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187 results on '"Mauro, F. R."'

2. The time to first treatment is an independent predictor of overall survival in chronic lymphocytic leukemia

Author

Morabito, Francesco, Tripepi, G., Mauro, F. R., Laurenti, Luca, Reda, G., Moia, R., Condoluci, A., Vincelli, I., Chiarenza, A., Vigna, E., Martino, E. A., Bruzzese, Maria Antonella, Mezzatesta, S., Laureana, R., Cutrona, G., Di Raimondo, F., Fronza, G., Zucchetto, A., Bomben, R., Rossi, Federica Maria, Olivieri, J., Zaja, F., Rossi, Dario, Gaidano, G., Del Principe, M. I., Ilariucci, F., Del Poeta, G., Ferrarini, M., Neri, A., Gattei, V., Gentile, M., Morabito F., Laurenti L. (ORCID:0000-0002-8327-1396), Bruzzese A., Rossi F. M., Rossi D., Morabito, Francesco, Tripepi, G., Mauro, F. R., Laurenti, Luca, Reda, G., Moia, R., Condoluci, A., Vincelli, I., Chiarenza, A., Vigna, E., Martino, E. A., Bruzzese, Maria Antonella, Mezzatesta, S., Laureana, R., Cutrona, G., Di Raimondo, F., Fronza, G., Zucchetto, A., Bomben, R., Rossi, Federica Maria, Olivieri, J., Zaja, F., Rossi, Dario, Gaidano, G., Del Principe, M. I., Ilariucci, F., Del Poeta, G., Ferrarini, M., Neri, A., Gattei, V., Gentile, M., Morabito F., Laurenti L. (ORCID:0000-0002-8327-1396), Bruzzese A., Rossi F. M., and Rossi D.

Abstract

NA

Published
2023

3. Ibrutinib in patients over 80 years old with CLL: a multicenter Italian cohort

Author

Reda, G., Mattiello, V., Frustaci, A. M., Visentin, A., Mauro, F. R., Innocenti, Idanna, Gentile, M., Giannarelli, Diana, Noto, A., Cassin, R., Neri, A., Laurenti, Luca, Tedeschi, Alessandra, Innocenti I., Giannarelli D., Laurenti L. (ORCID:0000-0002-8327-1396), Tedeschi A., Reda, G., Mattiello, V., Frustaci, A. M., Visentin, A., Mauro, F. R., Innocenti, Idanna, Gentile, M., Giannarelli, Diana, Noto, A., Cassin, R., Neri, A., Laurenti, Luca, Tedeschi, Alessandra, Innocenti I., Giannarelli D., Laurenti L. (ORCID:0000-0002-8327-1396), and Tedeschi A.

Abstract

NA

Published
2023

4. Efficacy of front-line ibrutinib versus fludarabine, cyclophosphamide, and rituximab in patients with chronic lymphocytic leukemia: A retrospective multicenter “Real-World” study

Author

Levi, S., Bronstein, Y., Goldschmidt, N., Morabito, Francesco, Ziv-Baran, T., Del Poeta, G., Bairey, O., Del Principe, M. I., Fineman, R., Mauro, F. R., Gutwein, O., Reda, G., Ruchlemer, R., Sportoletti, P., Laurenti, Luca, Shvidel, L., Coscia, M., Tadmor, T., Varettoni, M., Aviv, A., Murru, R., Braester, A., Chiarenza, A., Visentin, A., Pietrasanta, D., Loseto, G., Zucchetto, A., Bomben, R., Olivieri, J., Neri, A., Rossi, Dario, Gaidano, G., Trentin, L., Foa, Robin, Cuneo, A., Perry, C., Gattei, V., Gentile, M., Herishanu, Y., Morabito F., Laurenti L. (ORCID:0000-0002-8327-1396), Rossi D., Foa R., Levi, S., Bronstein, Y., Goldschmidt, N., Morabito, Francesco, Ziv-Baran, T., Del Poeta, G., Bairey, O., Del Principe, M. I., Fineman, R., Mauro, F. R., Gutwein, O., Reda, G., Ruchlemer, R., Sportoletti, P., Laurenti, Luca, Shvidel, L., Coscia, M., Tadmor, T., Varettoni, M., Aviv, A., Murru, R., Braester, A., Chiarenza, A., Visentin, A., Pietrasanta, D., Loseto, G., Zucchetto, A., Bomben, R., Olivieri, J., Neri, A., Rossi, Dario, Gaidano, G., Trentin, L., Foa, Robin, Cuneo, A., Perry, C., Gattei, V., Gentile, M., Herishanu, Y., Morabito F., Laurenti L. (ORCID:0000-0002-8327-1396), Rossi D., and Foa R.

Abstract

NA

Published
2023

5. SARS-CoV-2 infection in patients with chronic lymphocytic leukemia: The Italian Hematology Alliance on COVID-19 cohort

Author

Merli, M, Ferrarini, I, Merli, F, Busca, A, Mina, R, Falini, B, Bruna, R, Cairoli, R, Marchetti, M, Romano, A, Cavo, M, Arcaini, L, Trentin, L, Cattaneo, C, Derenzini, E, Fracchiolla, N, Marchesi, F, Scattolin, A, Billio, A, Bocchia, M, Massaia, M, Gambacorti-Passerini, C, Mauro, F, Gentile, M, Mohamed, S, Della Porta, M, Coviello, E, Cilloni, D, Visani, G, Federici, A, Tisi, M, Cudillo, L, Galimberti, S, Gherlinzoni, F, Pagano, L, Guidetti, A, Bertu, L, Corradini, P, Passamonti, F, Visco, C, Merli M., Ferrarini I., Merli F., Busca A., Mina R., Falini B., Bruna R., Cairoli R., Marchetti M., Romano A., Cavo M., Arcaini L., Trentin L., Cattaneo C., Derenzini E., Fracchiolla N. S., Marchesi F., Scattolin A., Billio A., Bocchia M., Massaia M., Gambacorti-Passerini C., Mauro F. R., Gentile M., Mohamed S., Della Porta M. G., Coviello E., Cilloni D., Visani G., Federici A. B., Tisi M. C., Cudillo L., Galimberti S., Gherlinzoni F., Pagano L., Guidetti A., Bertu L., Corradini P., Passamonti F., Visco C., Merli, M, Ferrarini, I, Merli, F, Busca, A, Mina, R, Falini, B, Bruna, R, Cairoli, R, Marchetti, M, Romano, A, Cavo, M, Arcaini, L, Trentin, L, Cattaneo, C, Derenzini, E, Fracchiolla, N, Marchesi, F, Scattolin, A, Billio, A, Bocchia, M, Massaia, M, Gambacorti-Passerini, C, Mauro, F, Gentile, M, Mohamed, S, Della Porta, M, Coviello, E, Cilloni, D, Visani, G, Federici, A, Tisi, M, Cudillo, L, Galimberti, S, Gherlinzoni, F, Pagano, L, Guidetti, A, Bertu, L, Corradini, P, Passamonti, F, Visco, C, Merli M., Ferrarini I., Merli F., Busca A., Mina R., Falini B., Bruna R., Cairoli R., Marchetti M., Romano A., Cavo M., Arcaini L., Trentin L., Cattaneo C., Derenzini E., Fracchiolla N. S., Marchesi F., Scattolin A., Billio A., Bocchia M., Massaia M., Gambacorti-Passerini C., Mauro F. R., Gentile M., Mohamed S., Della Porta M. G., Coviello E., Cilloni D., Visani G., Federici A. B., Tisi M. C., Cudillo L., Galimberti S., Gherlinzoni F., Pagano L., Guidetti A., Bertu L., Corradini P., Passamonti F., and Visco C.

Abstract

COVID-19, the disease caused by SARS-CoV-2, is still afflicting thousands of people across the globe. Few studies on COVID-19 in chronic lymphocytic leukemia (CLL) are available. Here, we analyzed data from the CLL cohort of the Italian Hematology Alliance on COVID-19 (NCT04352556), which included 256 CLL patients enrolled between 25 February 2020 and 1 February 2021. Median age was 70 years (range 38–94) with male preponderance (60.1%). Approximately half of patients (n = 127) had received at least one line of therapy for CLL, including 108 (83.7%) who were on active treatment at the time of COVID-19 or received their last therapy within 12 months. Most patients (230/256, 89.9%) were symptomatic at COVID-19 diagnosis and the majority required hospitalization (n = 176). Overall, after a median follow-up of 42 days (IQR 24–96), case fatality rate was 30.1%, and it was 37.5% and 24.4% in the first (25 February 2020–22 June 2020) and second wave (23 June 2020–1 February 2021), respectively (p = 0.03). At multivariate analysis, male sex (HR 1.82, 95% CI 1.03–3.24, p = 0.04), age over than 70 years (HR 2.23, 95% CI 1.23–4.05, p = 0.01), any treatment for CLL given in the last 12 months (HR 1.72, 95% CI 1.04–2.84, p = 0.04) and COVID-19 severity (severe: HR 5.66, 95% CI 2.62–12.33, p < 0.0001; critical: HR 15.99, 95% CI 6.93–36.90, p < 0.0001) were independently associated with poor survival. In summary, we report a dismal COVID-related outcome in a significant fraction of CLL patients, that can be nicely predicted by clinical parameters.

Published
2023

6. Chronic lymphocytic leukemia management in Italy during the COVID-19 pandemic: a Campus CLL report

Author

Cuneo, A., Scarfo, L., Reda, G., Varettoni, M., Quaglia, F. M., Marchetti, M., De Paoli, L., Re, F., Pietrasanta, D., Rigolin, G. M., Orsucci, L., Ibatici, A., Gattei, V., Mauro, F. R., Trentin, L., Laurenti, L., Marasca, R., Foa, R., Angeletti, I., Chiurazzi, F., Del Poeta, G., Rosaria De Paolis, M., Farina, L., Ferrari, A., Gentile, M., Gottardi, D., Gozzetti, A., Leone, M., Levato, L., Maccaferri, M., Malerba, L., Motta, M., Murru, R., Nocilli, L., Olivieri, J., Stefoni, V., Cuneo, A., Scarfo', L., Reda, G., Varettoni, M., Quaglia, F. M., Marchetti, M., De Paoli, L., Re, F., Pietrasanta, D., Rigolin, G. M., Orsucci, L., Ibatici, A., Gattei, V., Mauro, F. R., Trentin, L., Laurenti, L., Marasca, R., Foa, R., Angeletti, I., Chiurazzi, F., Del Poeta, G., Rosaria De Paolis, M., Farina, L., Ferrari, A., Gentile, M., Gottardi, D., Gozzetti, A., Leone, M., Levato, L., Maccaferri, M., Malerba, L., Motta, M., Murru, R., Nocilli, L., Olivieri, J., and Stefoni, V.

Subjects
Aged, Aged, 80 and over, Betacoronavirus, COVID-19, Coronavirus Infections, Disease Management, Humans, Italy, Leukemia, Lymphocytic, Chronic, B-Cell, Middle Aged, Pandemics, Pneumonia, Viral, SARS-CoV-2, Chronic lymphocytic leukemia, Biochemistry, chemistry.chemical_compound, Pandemic, 80 and over, Viral, Chronic, Disease management (health), Letter to Blood, Leukemia, Hematology, Lymphocytic, Ibrutinib, CLL, COVID-19, Campus CLL, medicine.medical_specialty, 2019-20 coronavirus outbreak, Coronavirus disease 2019 (COVID-19), Immunology, Cancer therapy, NO, Internal medicine, medicine, business.industry, B-Cell, Pneumonia, Cell Biology, Campus CLL, medicine.disease, Settore MED/15 - MALATTIE DEL SANGUE, chemistry, business, CLL
Published
2020
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7. A progression-risk score to predict treatment-free survival for early stage chronic lymphocytic leukemia patients

Author

Gentile, M, Shanafelt, T D, Cutrona, G, Molica, S, Tripepi, G, Alvarez, I, Mauro, F R, Di Renzo, N, Di Raimondo, F, Vincelli, I, Todoerti, K, Matis, S, Musolino, C, Fabris, S, Vigna, E, Levato, L, Zupo, S, Angrilli, F, Consoli, U, Festini, G, Longo, G, Cortelezzi, A, Arcari, A, Federico, M, Mannina, D, Recchia, A G, Neri, A, Kay, N E, Ferrarini, M, and Morabito, F

Published
2016
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9. P660: SEROLOGIC RESPONSE TO THE SECOND AND THIRD DOSE OF THE SARS-COV-2 VACCINE IN PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA: RESULTS OF A PROSPECTIVE, CENTRALIZED, MULTICENTER STUDY.

Author

Mauro, F. R., primary, Giannarelli, D., additional, Galluzzo, C., additional, Visentin, A., additional, Frustaci, A. M., additional, Sportoletti, P., additional, Vitale, C., additional, Reda, G., additional, Gentile, M., additional, Levato, L., additional, Murru, R., additional, Armiento, D., additional, Ielo, C., additional, Maglione, R., additional, Crisanti, E., additional, Cipiciani, A., additional, Mattiello, V., additional, Gianfelici, V., additional, Barabino, L., additional, Amici, R., additional, Coscia, M., additional, Tedeschi, A., additional, Trentin, L., additional, and Baroncelli, S., additional

Published
2022
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10. P664: GRADING QUALITY OF EVIDENCE AND STRENGTH OF RECOMMENDATIONS FOR THE TREATMENT OF RELAPSED/REFRACTORY CLL.

Author

Molica, S., primary, Patti, C., additional, Sportoletti, P., additional, Chiarenza, A., additional, Giordano, A. M., additional, Chiurazzi, F., additional, Di Renzo, N., additional, Musto, P., additional, Pane, F., additional, Di Raimondo, F., additional, Trentin, L., additional, Mauro, F. R., additional, and Giannarelli, D., additional

Published
2022
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11. Long-term benefit of IGHV mutated patients in a real-life multicenter cohort of FCR-treated chronic lymphocytic leukemia

Author

Moia, R., Dondolin, R., De Propris, M. S., Talotta, D., Mouhssine, S., Perutelli, F., Reda, G., Mattiello, V., Rigolin, G. M., Motta, M., Olivieri, J., Fanin, R., Perbellini, O., Ferrarini, I., Mauro, F. R., Del Giudice, I., Laurenti, Luca, Tomasso, Annamaria, Gentile, M., Frustaci, A. M., Tedeschi, Alessandra, Gozzetti, A., Stelitano, C., Visco, C., Moreno, C., Forconi, F., Marasca, R., Coscia, M., Rossi, Dario, Foa, Robin, Gaidano, G., Laurenti L. (ORCID:0000-0002-8327-1396), Tomasso A., Tedeschi A., Rossi D., Foa R., Moia, R., Dondolin, R., De Propris, M. S., Talotta, D., Mouhssine, S., Perutelli, F., Reda, G., Mattiello, V., Rigolin, G. M., Motta, M., Olivieri, J., Fanin, R., Perbellini, O., Ferrarini, I., Mauro, F. R., Del Giudice, I., Laurenti, Luca, Tomasso, Annamaria, Gentile, M., Frustaci, A. M., Tedeschi, Alessandra, Gozzetti, A., Stelitano, C., Visco, C., Moreno, C., Forconi, F., Marasca, R., Coscia, M., Rossi, Dario, Foa, Robin, Gaidano, G., Laurenti L. (ORCID:0000-0002-8327-1396), Tomasso A., Tedeschi A., Rossi D., and Foa R.

Abstract

NA

Published
2022

12. Obinutuzumab plus chlorambucil versus ibrutinib in previously untreated chronic lymphocytic leukemia patients without TP53 disruptions: A real-life CLL campus study

Author

Visentin, A., Mauro, F. R., Catania, G., Fresa, Alberto, Vitale, C., Sanna, A., Mattiello, V., Cibien, F., Sportoletti, P., Gentile, M., Rigolin, G. M., Quaglia, F. M., Murru, R., Gozzetti, A., Molica, Serena, Marchetti, M., Pravato, S., Angotzi, F., Cellini, A., Scarfo, L., Reda, G., Coscia, M., Laurenti, Luca, Ghia, P., Foa, Robin, Cuneo, A., Trentin, L., Fresa A., Molica S., Laurenti L. (ORCID:0000-0002-8327-1396), Foa R., Visentin, A., Mauro, F. R., Catania, G., Fresa, Alberto, Vitale, C., Sanna, A., Mattiello, V., Cibien, F., Sportoletti, P., Gentile, M., Rigolin, G. M., Quaglia, F. M., Murru, R., Gozzetti, A., Molica, Serena, Marchetti, M., Pravato, S., Angotzi, F., Cellini, A., Scarfo, L., Reda, G., Coscia, M., Laurenti, Luca, Ghia, P., Foa, Robin, Cuneo, A., Trentin, L., Fresa A., Molica S., Laurenti L. (ORCID:0000-0002-8327-1396), and Foa R.

Abstract

One of the main issues in the treatment of patients with chronic lymphocytic leukemia (CLL) deals with the choice between continuous or fixed-duration therapy. Continuous ibrutinib (IB), the first-in-class BTK inhibitor, and obinutuzumab-chlorambucil (G-CHL) are commonly used therapies for elderly and/or comorbid patients. No head-to-head comparison has been carried out. Within the Italian campus CLL network, we performed a retrospective study on CLL patients without TP53 disruption treated with IB or G-CHL as first-line therapy. Patients in the G-CHL arm had a higher CIRS score and the worst renal function. The overall response rates between the G-CHL and IB arms were similar, but more complete remissions (CRs) were achieved with G-CHL (p = 0.0029). After a median follow-up of 30 months, the progression-free survival (PFS, p = 0.0061) and time to next treatment (TTNT, p = 0.0043), but not overall survival (OS, p = 0.6642), were better with IB than with G-CHL. Similar results were found after propensity score matching and multivariate analysis. While PFS and TTNT were longer with IB than with G-CHL in IGHV unmutated patients (p = 0.0190 and 0.0137), they were superimposable for IGHV mutated patients (p = 0.1900 and 0.1380). In the G-CHL arm, the depth of response (79% vs. 68% vs. 38% for CR, PR and SD/PD; p < 0.0001) and measurable residual disease (MRD) influenced PFS (78% vs. 53% for undetectable MRD vs. detectable MRD, p = 0.0203). Hematological toxicities were common in the G-CHL arm, while IB was associated with higher costs. Although continuous IB provides better disease control in CLL, IGHV mutated patients and those achieving an undetectable MRD show a marked clinical and economic benefit from a fixed-duration obinutuzumab-based treatment.

Published
2022

14. Bendamustine in combination with Ofatumumab in relapsed or refractory chronic lymphocytic leukemia: a GIMEMA Multicenter Phase II Trial

Author

Cortelezzi, A, Sciumè, M, Liberati, A M, Vincenti, D, Cuneo, A, Reda, G, Laurenti, L, Zaja, F, Marasca, R, Chiarenza, A, Gritti, G, Orsucci, L, Storti, S, Angelucci, E, Cascavilla, N, Gobbi, M, Mauro, F R, Morabito, F, Fabris, S, Piciocchi, A, Vignetti, M, Neri, A, Rossi, D, Giannarelli, D, Guarini, A, and Foà, R

Published
2014
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15. EFFICACY AND DISCONTINUATION RATE OF IBRUTINIB IN TREATMENT NAIVE CHRONIC LYMPHOCYTIC LEUKEMIA PATIENTS WITH TP53 ABNORMALITIES. A REAL‐LIFE CAMPUS CLL STUDY

Author

Visentin, A., primary, Mauro, F. R., additional, Cibien, F., additional, Vitale, C., additional, Reda, G., additional, Fresa, A., additional, Ciolli, S., additional, Pietrasanta, D., additional, Marchetti, M., additional, Murru, R., additional, Gentile, M., additional, Rigolin, G. M., additional, Quaglia, F. M., additional, Scarfò, L., additional, Sportoletti, P., additional, Pravato, S., additional, Romano Gargarella, L., additional, Facco, M., additional, Piazza, F., additional, Coscia, M., additional, Laurenti, L., additional, Molica, S., additional, Pizzolo, G., additional, Foà, R., additional, Cuneo, A., additional, and Trentim, L., additional

Published
2021
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16. Efficacy of idelalisib and rituximab in relapsed/refractory chronic lymphocytic leukemia treated outside of clinical trials. A report of the Gimema Working Group

Author

Rigolin, G. M., Cavazzini, F., Piciocchi, A., Arena, V., Visentin, A., Reda, G., Zamprogna, G., Cibien, F., Vitagliano, O., Coscia, M., Farina, L., Gaidano, G., Murru, R., Varettoni, M., Paolini, R., Sportoletti, P., Pietrasanta, D., Molinari, A. L., Quaglia, F. M., Laurenti, L., Marasca, R., Marchetti, M., Mauro, F. R., Crea, E., Vignetti, M., Gentile, M., Montillo, M., Foa, R., Cuneo, A., Chiarenza, A., Perbellini, O., Mannina, D., Sancetta, R., Olivieri, A., Molica, S., Pane, F., Patti, C., Iliariucci, F., Gozzetti, A., Califano, C., Galieni, P., Augello, A. F., Vallisa, D., Cura, F., Frustaci, A. M., Fazi, P., Trentin, L., and Ferrara, F.

Subjects
Male, Oncology, Cancer Research, idelalisib, law.invention, 0302 clinical medicine, Randomized controlled trial, Recurrence, law, Original Research Articles, Antineoplastic Combined Chemotherapy Protocols, 80 and over, Original Research Article, Chronic, Aged, 80 and over, Leukemia, real‐world evidence, Hematology, General Medicine, Middle Aged, Lymphocytic, Survival Rate, 030220 oncology & carcinogenesis, Female, Rituximab, Refractory Chronic Lymphocytic Leukemia, Idelalisib, chronic lymphocytic leukemia, real-world evidence, Aged, Disease-Free Survival, Humans, Leukemia, Lymphocytic, Chronic, B-Cell, Purines, Quinazolinones, medicine.drug, medicine.medical_specialty, NO, 03 medical and health sciences, Internal medicine, medicine, Survival rate, Performance status, business.industry, B-Cell, Clinical trial, Settore MED/15 - MALATTIE DEL SANGUE, Regimen, business, 030215 immunology
Abstract

Because the efficacy of new drugs reported in trials may not translate into similar results when used in the real‐life, we analyzed the efficacy of idelalisib and rituximab (IR) in 149 patients with relapsed/refractory chronic lymphocytic leukemia treated at 34 GIMEMA centers. Median progression‐free survival (PFS) and overall survival were 22.9 and 44.5 months, respectively; performance status (PS) ≥2 and ≥3 previous lines of therapy were associated with shorter PFS and overall survival (OS). 48% of patients were on treatment at 12 months; the experience of the centers (≥5 treated patients) and PS 0–1 were associated with a significantly longer treatment duration (p = 0.015 and p = 0.002, respectively). TP53 disruption had no prognostic significance. The overall response rate to subsequent treatment was 49.2%, with median OS of 15.5 months and not reached in patients who discontinued, respectively, for progression and for toxicity (p

Published
2021

17. Do age, fitness, and concomitant medications influence management and outcomes of patients with CLL treated with ibrutinib?

Author

Tedeschi, A, Frustaci, A, Mauro, F, Chiarenza, A, Coscia, M, Ciolli, S, Reda, G, Laurenti, L, Varettoni, M, Murru, R, Barate, C, Sportoletti, P, Greco, A, Borella, C, Rossi, V, Deodato, M, Biagi, A, Zamprogna, G, Pelle, A, Lapietra, G, Vitale, C, Morelli, F, Cassin, R, Fresa, A, Cavalloni, C, Postorino, M, Ielo, C, Cairoli, R, Di Raimondo, F, Montillo, M, Del Poeta, G, Tedeschi A., Frustaci A. M., Mauro F. R., Chiarenza A., Coscia M., Ciolli S., Reda G., Laurenti L., Varettoni M., Murru R., Barate C., Sportoletti P., Greco A., Borella C., Rossi V., Deodato M., Biagi A., Zamprogna G., Pelle A. C., Lapietra G., Vitale C., Morelli F., Cassin R., Fresa A., Cavalloni C., Postorino M., Ielo C., Cairoli R., Di Raimondo F., Montillo M., Del Poeta G., Tedeschi, A, Frustaci, A, Mauro, F, Chiarenza, A, Coscia, M, Ciolli, S, Reda, G, Laurenti, L, Varettoni, M, Murru, R, Barate, C, Sportoletti, P, Greco, A, Borella, C, Rossi, V, Deodato, M, Biagi, A, Zamprogna, G, Pelle, A, Lapietra, G, Vitale, C, Morelli, F, Cassin, R, Fresa, A, Cavalloni, C, Postorino, M, Ielo, C, Cairoli, R, Di Raimondo, F, Montillo, M, Del Poeta, G, Tedeschi A., Frustaci A. M., Mauro F. R., Chiarenza A., Coscia M., Ciolli S., Reda G., Laurenti L., Varettoni M., Murru R., Barate C., Sportoletti P., Greco A., Borella C., Rossi V., Deodato M., Biagi A., Zamprogna G., Pelle A. C., Lapietra G., Vitale C., Morelli F., Cassin R., Fresa A., Cavalloni C., Postorino M., Ielo C., Cairoli R., Di Raimondo F., Montillo M., and Del Poeta G.

Abstract

Functional reserve of organs and systems is known to be relevant in predicting immunochemotherapy tolerance. Age and comorbidities, assessed by the cumulative illness rating scale (CIRS), have been used to address chemotherapy intensity. In the ibrutinib era, it is still unclear whether age, CIRS, and Eastern Cooperative Oncology Group performance status (ECOG-PS) retain their predictive role on treatment vulnerability. In this series of 712 patients with chronic lymphocytic leukemia (CLL) treated with ibrutinib outside clinical trials, baseline ECOG-PS and neutropenia resulted as the most accurate predictors of treatment feasibility and outcomes. Age did not independently influence survival and ibrutinib tolerance, indicating that not age per se, but age-related conditions, may affect drug management. We confirmed the role of CIRS . 6 as a predictor of a poorer progression- and event-free survival (PFS, EFS). The presence of a severe comorbidity was significantly associated with permanent dose reductions (PDRs), not translating into worse outcomes. As expected, del(17p) and/or TP53mut and previous therapies affected PFS, EFS, and overall survival. No study so far has analyzed the influence of concomitant medications and CYP3A inhibitors with ibrutinib. In our series, these factors had no impact, although CYP3A4 inhibitors use correlated with Cox regression analysis, with an increased risk of PDR. Despite the limitation of its retrospective nature, this large study confirmed the role of ECOG-PS as the most accurate predictor of ibrutinib feasibility and outcomes, and importantly, neutropenia emerged as a relevant tool influencing patients’ vulnerability. Although CIRS > 6 retained a significant impact on PFS and EFS, its value should be confirmed by prospective studies.

Published
2021

18. Effectiveness of ibrutinib as first-line therapy for chronic lymphocytic leukemia patients and indirect comparison with rituximab-bendamustine: Results of study on 486 cases outside clinical trials

Author

Morabito, F., Tripepi, G., Del Poeta, G., Mauro, F. R., Reda, G., Sportoletti, P., Laurenti, L., Coscia, M., Herishanu, Y., Bossio, S., Varettoni, M., Murru, R., Chiarenza, A., Visentin, A., Condoluci, A., Moia, R., Pietrasanta, D., Loseto, G., Consoli, U., Scortechini, I., Rossi, F. M., Zucchetto, A., Al-Janazreh, H., Vigna, E., Martino, E. A., Cassin, R., D'Arrigo, G., Galimberti, S., Rago, A., Angeletti, I., Biagi, A., Del Giudice, I., Bomben, R., Neri, A., Fronza, G., Monti, P., Menichini, P., Olivieri, J., Cutrona, G., Rossi, D., Cuneo, A., Di Raimondo, F., Gaidano, G., Polliack, A., Trentin, L., Foa, R., Ferrarini, M., Gattei, V., Gentile, M., Morabito F., Laurenti L. (ORCID:0000-0002-8327-1396), Rossi F. M., Galimberti S., Monti P. (ORCID:0000-0002-2586-1881), Rossi D., Foa R., Gentile M., Morabito, F., Tripepi, G., Del Poeta, G., Mauro, F. R., Reda, G., Sportoletti, P., Laurenti, L., Coscia, M., Herishanu, Y., Bossio, S., Varettoni, M., Murru, R., Chiarenza, A., Visentin, A., Condoluci, A., Moia, R., Pietrasanta, D., Loseto, G., Consoli, U., Scortechini, I., Rossi, F. M., Zucchetto, A., Al-Janazreh, H., Vigna, E., Martino, E. A., Cassin, R., D'Arrigo, G., Galimberti, S., Rago, A., Angeletti, I., Biagi, A., Del Giudice, I., Bomben, R., Neri, A., Fronza, G., Monti, P., Menichini, P., Olivieri, J., Cutrona, G., Rossi, D., Cuneo, A., Di Raimondo, F., Gaidano, G., Polliack, A., Trentin, L., Foa, R., Ferrarini, M., Gattei, V., Gentile, M., Morabito F., Laurenti L. (ORCID:0000-0002-8327-1396), Rossi F. M., Galimberti S., Monti P. (ORCID:0000-0002-2586-1881), Rossi D., Foa R., and Gentile M.

Abstract

n/a

Published
2021

19. Comparison of ibrutinib and idelalisib plus rituximab in real-life relapsed/resistant chronic lymphocytic leukemia cases

Author

Morabito, Francesco, Tripepi, G., Del Poeta, G., Mauro, F. R., Reda, G., Sportoletti, P., Laurenti, Luca, Coscia, M., Herishanu, Y., Bossio, S., Varettoni, M., Murru, R., Chiarenza, A., Visentin, A., Condoluci, A., Moia, R., Pietrasanta, D., Loseto, G., Consoli, U., Scortechini, I., Rossi, Federica Maria, Zucchetto, A., Al-Janazreh, H., Vigna, E., Martino, E. A., Mendicino, F., Cassin, R., D'Arrigo, G., Galimberti, Sofia, Rago, A., Angeletti, I., Biagi, A., Del Giudice, I., Bomben, R., Neri, A., Fronza, G., Monti, Paolo, Menichini, P., Cutrona, G., Jaksic, O., Rossi, Dario, Di Raimondo, F., Cuneo, A., Gaidano, G., Polliack, A., Trentin, L., Foa, Robin, Ferrarini, M., Gattei, V., Gentile, Marino, Morabito F., Laurenti L. (ORCID:0000-0002-8327-1396), Rossi F. M., Galimberti S., Monti P. (ORCID:0000-0002-2586-1881), Rossi D., Foa R., Gentile M., Morabito, Francesco, Tripepi, G., Del Poeta, G., Mauro, F. R., Reda, G., Sportoletti, P., Laurenti, Luca, Coscia, M., Herishanu, Y., Bossio, S., Varettoni, M., Murru, R., Chiarenza, A., Visentin, A., Condoluci, A., Moia, R., Pietrasanta, D., Loseto, G., Consoli, U., Scortechini, I., Rossi, Federica Maria, Zucchetto, A., Al-Janazreh, H., Vigna, E., Martino, E. A., Mendicino, F., Cassin, R., D'Arrigo, G., Galimberti, Sofia, Rago, A., Angeletti, I., Biagi, A., Del Giudice, I., Bomben, R., Neri, A., Fronza, G., Monti, Paolo, Menichini, P., Cutrona, G., Jaksic, O., Rossi, Dario, Di Raimondo, F., Cuneo, A., Gaidano, G., Polliack, A., Trentin, L., Foa, Robin, Ferrarini, M., Gattei, V., Gentile, Marino, Morabito F., Laurenti L. (ORCID:0000-0002-8327-1396), Rossi F. M., Galimberti S., Monti P. (ORCID:0000-0002-2586-1881), Rossi D., Foa R., and Gentile M.

Abstract

Objectives: To compare the capacity of ibrutinib (IB) and idelalisib-rituximab (IDELA-R) of prolonging overall survival (OS) as in CLL patients, previously treated with chemotherapy only. Methods: A real-life cohort of 675 cases has been identified and investigated in the database of the groups participating in the study. Results: At an unadjusted univariate analysis, a significant death risk reduction was observed favoring IB (IDELA-R vs IB HR = 0.5, 95% CI = 0.36-0.71) although with some limitations due to the non-randomized and retrospective nature of the study and to the lower number of patients in the IDELA-R group (112 cases) related to the current prescribing practice. To overcome the potential problem of confounding by indication, we adjusted the association between the type of therapy and mortality for all variables significantly associated with OS at Cox univariate analysis. Furthermore, those variables, differently distributed between the two study groups, were introduced into the multivariate Cox model to improve the effectiveness of the analysis. By introducing all these variables into the multiple Cox regression model, we confirmed the protective effect of IB vs IDELA-R (HR = 0.67, 95% CI = 0.45-0.98, P =.04) independent of potential confounders. Conclusions: Although our analysis presents some constraints, that is, the unavailability of additional potential confounders, and the retrospective nature of the study, this observation may be of help for the daily clinical practice, particularly in the absence of randomized trials comparing the two schedules.

Published
2021

20. Prognostic impact and risk factors of infections in patients with chronic lymphocytic leukemia treated with ibrutinib

Author

Mauro, F. R., Giannarelli, D., Visentin, A., Reda, G., Sportoletti, P., Frustaci, A. M., Chiarenza, A., Ciolli, S., Vitale, C., Laurenti, L., De Paoli, L., Murru, R., Gentile, M., Rigolin, G. M., Levato, L., Giordano, A., Del Poeta, G., Stelitano, C., Ielo, C., Noto, A., Guarente, V., Molica, S., Coscia, M., Tedeschi, A., Gaidano, G., Cuneo, A., Foa, R., Martelli, M., Girmenia, C., Gentile, G., Trentin, L., Laurenti L. (ORCID:0000-0002-8327-1396), Gentile M., Molica S., Tedeschi A., Foa R., Martelli M., Gentile G., Mauro, F. R., Giannarelli, D., Visentin, A., Reda, G., Sportoletti, P., Frustaci, A. M., Chiarenza, A., Ciolli, S., Vitale, C., Laurenti, L., De Paoli, L., Murru, R., Gentile, M., Rigolin, G. M., Levato, L., Giordano, A., Del Poeta, G., Stelitano, C., Ielo, C., Noto, A., Guarente, V., Molica, S., Coscia, M., Tedeschi, A., Gaidano, G., Cuneo, A., Foa, R., Martelli, M., Girmenia, C., Gentile, G., Trentin, L., Laurenti L. (ORCID:0000-0002-8327-1396), Gentile M., Molica S., Tedeschi A., Foa R., Martelli M., and Gentile G.

Abstract

Ibrutinib represents extraordinary progress in the treatment of chronic lymphocytic leukemia (CLL). However, treatment-related adverse events limit the benefit of this agent. This obser-vational, multicenter study focused on the incidence, risk factors, and prognostic impact of infections in 494 patients with CLL treated with an ibrutinib-based treatment. Ibrutinib was given to 89 (18%) previously untreated patients (combined with rituximab, 24) and 405 (82%) relapsed/refractory patients. Pneumonia (PN), grade ≥3 non-opportunistic infections (NOI), and opportunistic infections (OI) were recorded in 32% of patients with an overall incidence rate per 100 person-year of 15.3% (PN, 10%; NOI, 3.3%; OI, 2%). Infections were the reason for the permanent discontinuation of ibrutinib in 9% of patients. Patients who experienced pneumonia or a severe infection showed a significantly inferior survival than those who were infection-free (p < 0.0001). A scoring system based on the three factors associated with a significant and independent impact on infections—PN or severe infection in the year before starting ibrutinib, chronic obstructive pulmonary disease, ≥2 prior treatments—identified patients with a two-to threefold increase in the rate of infections. In conclusion, the results of this study highlight the adverse impact of infectious events on the outcomes of CLL patients treated with ibrutinib.

Published
2021

21. Management of chronic lymphocytic leukemia in Italy during a one year of the COVID-19 pandemic and at the start of the vaccination program. A Campus CLL report

Author

Cuneo, A., Rigolin, G. M., Coscia, M., Quaresmini, G., Scarfo, L., Mauro, F. R., Motta, M., Quaglia, F. M., Trentin, L., Ferrario, Alberto Alfredo, Laurenti, Luca, Reda, G., Ferrari, A., Pietrasanta, D., Sportoletti, P., Re, F., De Paoli, L., Foglietta, M., Giordano, A., Marchetti, M., Farina, L., Del Poeta, G., Varettoni, M., Chiurazzi, F., Marasca, R., Malerba, L., Ibatici, A., Tisi, Maria Chiara, Stefoni, V., Leone, M., Barate, C., Olivieri, J., Murru, R., Gentile, Marino, Sanna, A., Gozzetti, A., Gattei, V., Gottardi, D., Derenzini, E., Levato, L., Orsucci, L., Penna, G., Chiarenza, A., Foa, Robin, Ferrario A., Laurenti L. (ORCID:0000-0002-8327-1396), Tisi M. C., Gentile M., Foa R., Cuneo, A., Rigolin, G. M., Coscia, M., Quaresmini, G., Scarfo, L., Mauro, F. R., Motta, M., Quaglia, F. M., Trentin, L., Ferrario, Alberto Alfredo, Laurenti, Luca, Reda, G., Ferrari, A., Pietrasanta, D., Sportoletti, P., Re, F., De Paoli, L., Foglietta, M., Giordano, A., Marchetti, M., Farina, L., Del Poeta, G., Varettoni, M., Chiurazzi, F., Marasca, R., Malerba, L., Ibatici, A., Tisi, Maria Chiara, Stefoni, V., Leone, M., Barate, C., Olivieri, J., Murru, R., Gentile, Marino, Sanna, A., Gozzetti, A., Gattei, V., Gottardi, D., Derenzini, E., Levato, L., Orsucci, L., Penna, G., Chiarenza, A., Foa, Robin, Ferrario A., Laurenti L. (ORCID:0000-0002-8327-1396), Tisi M. C., Gentile M., and Foa R.

Abstract

n/a

Published
2021

22. Assessment of the 4-factor score: Retrospective analysis of 586 CLL patients receiving ibrutinib. A campus CLL study

Author

Morabito, Francesco, Tripepi, G., Del Poeta, G., Mauro, F. R., Reda, G., Sportoletti, P., Laurenti, Luca, Coscia, M., Herishanu, Y., Varettoni, M., Murru, R., Chiarenza, A., Visentin, A., Condoluci, A., Moia, R., Pietrasanta, D., Loseto, G., Consoli, U., Scortechini, I., Rossi, Federica Maria, Zucchetto, A., Vigna, E., Martino, E. A., Mendicino, F., Botta, C., Caracciolo, D., Cassin, R., D'Arrigo, G., Galimberti, Sofia, Rago, A., Angeletti, I., Biagi, A., Del Giudice, I., Bomben, R., Neri, A., Fronza, G., Cutrona, G., Rossi, Dario, Di Raimondo, F., Cuneo, A., Gaidano, G., Polliack, A., Trentin, L., Foa, Robin, Ferrarini, M., Gattei, V., Gentile, Marino, Morabito F., Laurenti L. (ORCID:0000-0002-8327-1396), Rossi F. M., Galimberti S., Rossi D., Foa R., Gentile M., Morabito, Francesco, Tripepi, G., Del Poeta, G., Mauro, F. R., Reda, G., Sportoletti, P., Laurenti, Luca, Coscia, M., Herishanu, Y., Varettoni, M., Murru, R., Chiarenza, A., Visentin, A., Condoluci, A., Moia, R., Pietrasanta, D., Loseto, G., Consoli, U., Scortechini, I., Rossi, Federica Maria, Zucchetto, A., Vigna, E., Martino, E. A., Mendicino, F., Botta, C., Caracciolo, D., Cassin, R., D'Arrigo, G., Galimberti, Sofia, Rago, A., Angeletti, I., Biagi, A., Del Giudice, I., Bomben, R., Neri, A., Fronza, G., Cutrona, G., Rossi, Dario, Di Raimondo, F., Cuneo, A., Gaidano, G., Polliack, A., Trentin, L., Foa, Robin, Ferrarini, M., Gattei, V., Gentile, Marino, Morabito F., Laurenti L. (ORCID:0000-0002-8327-1396), Rossi F. M., Galimberti S., Rossi D., Foa R., and Gentile M.

Abstract

n/a

Published
2021

23. Survival risk score for real-life relapsed/refractory chronic lymphocytic leukemia patients receiving ibrutinib. A campus CLL study

Author

Gentile, Marino, Morabito, Francesco, Del Poeta, G., Mauro, F. R., Reda, G., Sportoletti, P., Laurenti, Luca, Coscia, M., Herishanu, Y., Recchia, A. G., Varettoni, M., Murru, R., Chiarenza, A., Condoluci, A., Moia, R., Pietrasanta, D., Loseto, G., Consoli, U., Scortechini, I., Rossi, Federica Maria, Zucchetto, A., Fraticelli, V., Vigna, E., Botta, C., Tripepi, G., Arrigo, G. D., Rago, A., Angeletti, I., Biagi, A., Del Giudice, I., Bomben, R., Rigolin, G. M., Rossi, Dario, Di Raimondo, F., Gaidano, G., Polliack, A., Cuneo, A., Foa, Robin, Gattei, V., Gentile M., Morabito F., Laurenti L. (ORCID:0000-0002-8327-1396), Rossi F. M., Rossi D., Foa R., Gentile, Marino, Morabito, Francesco, Del Poeta, G., Mauro, F. R., Reda, G., Sportoletti, P., Laurenti, Luca, Coscia, M., Herishanu, Y., Recchia, A. G., Varettoni, M., Murru, R., Chiarenza, A., Condoluci, A., Moia, R., Pietrasanta, D., Loseto, G., Consoli, U., Scortechini, I., Rossi, Federica Maria, Zucchetto, A., Fraticelli, V., Vigna, E., Botta, C., Tripepi, G., Arrigo, G. D., Rago, A., Angeletti, I., Biagi, A., Del Giudice, I., Bomben, R., Rigolin, G. M., Rossi, Dario, Di Raimondo, F., Gaidano, G., Polliack, A., Cuneo, A., Foa, Robin, Gattei, V., Gentile M., Morabito F., Laurenti L. (ORCID:0000-0002-8327-1396), Rossi F. M., Rossi D., and Foa R.

Abstract

N/A

Published
2021

24. Preexisting and treatment-emergent autoimmune cytopenias in patients with CLL treated with targeted drugs

Author

Vitale, C., Salvetti, Maria Cristina, Griggio, V., Porrazzo, M., Schiattone, L., Zamprogna, G., Visentin, A., Vassallo, F., Cassin, R., Rigolin, G. M., Murru, R., Laurenti, Luca, Rivela, P., Marchetti, M., Pennese, E., Gentile, Marino, Boccellato, E., Perutelli, F., Montalbano, M. C., De Paoli, L., Reda, G., Orsucci, L., Trentin, L., Cuneo, A., Tedeschi, Alessandra, Scarfo, L., Gaidano, G., Mauro, F. R., Foa, Robin, Boccadoro, M., Coscia, M., Salvetti C., Laurenti L. (ORCID:0000-0002-8327-1396), Gentile M., Tedeschi A., Foa R., Vitale, C., Salvetti, Maria Cristina, Griggio, V., Porrazzo, M., Schiattone, L., Zamprogna, G., Visentin, A., Vassallo, F., Cassin, R., Rigolin, G. M., Murru, R., Laurenti, Luca, Rivela, P., Marchetti, M., Pennese, E., Gentile, Marino, Boccellato, E., Perutelli, F., Montalbano, M. C., De Paoli, L., Reda, G., Orsucci, L., Trentin, L., Cuneo, A., Tedeschi, Alessandra, Scarfo, L., Gaidano, G., Mauro, F. R., Foa, Robin, Boccadoro, M., Coscia, M., Salvetti C., Laurenti L. (ORCID:0000-0002-8327-1396), Gentile M., Tedeschi A., and Foa R.

Abstract

Autoimmune cytopenias (AICs) affect 5% to 9% of patients with chronic lymphocytic leukemia (CLL). Targeted drugs—ibrutinib, idelalisib, and venetoclax—have a prominent role in the treatment of CLL, but their impact on CLL-associated AICs is largely unknown. In this study, we evaluated the characteristics and outcome of preexisting AICs and described the incidence, quality, and management of treatment-emergent AICs during therapy with targeted drugs in patients with CLL. We collected data from 572 patients treated with ibrutinib (9% in combination with an anti-CD20 monoclonal antibody), 143 treated with idelalisib-rituximab, and 100 treated with venetoclax (12% in combination with an anti-CD20 monoclonal antibody). A history of preexisting AICs was reported in 104 (13%) of 815 patients. Interestingly, 80% of patients whose AICs had not resolved when treatment with a targeted drug was started experienced an improvement or a resolution during therapy. Treatment-emergent AICs occurred in 1% of patients during ibrutinib therapy, in 0.9% during idelalisib therapy, and in 7% during venetoclax therapy, with an estimated incidence rate of 5, 6, and 69 episodes per 1000 patients per year of exposure in the 3 treatment groups, respectively. The vast majority of patients who developed treatment-emergent AICs had unfavorable biological features such as an unmutated IGHV and a del(17p) and/or TP53 mutation. Notably, despite AICs, 83% of patients were able to continue the targeted drug, in some cases in combination with additional immunosuppressive agents. Overall, treatment with ibrutinib, idelalisib, or venetoclax seems to have a beneficial impact on CLL-associated AICs, inducing an improvement or even a resolution of preexisting AICs in most cases and eliciting treatment-emergent AICs in a negligible portion of patients.

Published
2021

26. HIF-1α is over-expressed in leukemic cells from TP53-disrupted patients and is a promising therapeutic target in chronic lymphocytic leukemia

Author

Griggio, V., Vitale, C., Todaro, M., Riganti, C., Kopecka, J., Salvetti, C., Bomben, R., M. D., Bo, Magliulo, D., Rossi, D., Pozzato, G., Bonello, L., Marchetti, M., Omede, P., Kodipad, A. A., Laurenti, L., Poeta, G. D., Mauro, F. R., Bernardi, R., Zenz, T., Gattei, V., Gaidano, G., Foa, R., Massaia, M., Boccadoro, M., and Coscia, M.

Subjects
Animals, Humans, Hypoxia-Inducible Factor 1, alpha Subunit, Mice, Phosphatidylinositol 3-Kinases, Tumor Microenvironment, Tumor Suppressor Protein p53, Von Hippel-Lindau Tumor Suppressor Protein, Leukemia, Lymphocytic, Chronic, B-Cell
Published
2020

27. Validation of a survival-risk score (SRS) in relapsed/refractory CLL patients treated with idelalisib–rituximab

Author

Gentile, Marino, Martino, E. A., Visentin, A., Coscia, M., Reda, G., Sportoletti, P., Mauro, F. R., Laurenti, Luca, Varettoni, M., Murru, R., Chiarenza, A., Vigna, E., Mendicino, F., Lucia, E., Bossio, S., Recchia, A. G., Moia, R., Pietrasanta, D., Loseto, G., Consoli, U., Scortechini, I., Rossi, Federica Maria, Zucchetto, A., Al-Janazreh, H., Vitale, C., Tripepi, G., D'Arrigo, G., Angeletti, I., Bomben, R., Neri, A., Cutrona, G., Fronza, G., Di Raimondo, F., Gaidano, G., Cuneo, A., Foa, Robin, Ferrarini, M., Trentin, L., Gattei, V., Morabito, Francesco, Gentile M., Laurenti L. (ORCID:0000-0002-8327-1396), Rossi F. M., Foa R., Morabito F., Gentile, Marino, Martino, E. A., Visentin, A., Coscia, M., Reda, G., Sportoletti, P., Mauro, F. R., Laurenti, Luca, Varettoni, M., Murru, R., Chiarenza, A., Vigna, E., Mendicino, F., Lucia, E., Bossio, S., Recchia, A. G., Moia, R., Pietrasanta, D., Loseto, G., Consoli, U., Scortechini, I., Rossi, Federica Maria, Zucchetto, A., Al-Janazreh, H., Vitale, C., Tripepi, G., D'Arrigo, G., Angeletti, I., Bomben, R., Neri, A., Cutrona, G., Fronza, G., Di Raimondo, F., Gaidano, G., Cuneo, A., Foa, Robin, Ferrarini, M., Trentin, L., Gattei, V., Morabito, Francesco, Gentile M., Laurenti L. (ORCID:0000-0002-8327-1396), Rossi F. M., Foa R., and Morabito F.

Abstract

N/a

Published
2020

28. Frontline treatment with the combination obinutuzumab ± chlorambucil for chronic lymphocytic leukemia outside clinical trials: Results of a multinational, multicenter study by ERIC and the Israeli CLL study group

Author

Herishanu, Y., Shaulov, A., Fineman, R., Basic-Kinda, S., Aviv, A., Wasik-Szczepanek, E., Jaksic, O., Zdrenghea, M., Greenbaum, U., Mandac, I., Simkovic, M., Morawska, M., Benjamini, O., Spacek, M., Nemets, A., Bairey, O., Trentin, L., Ruchlemer, R., Laurenti, Luca, Stanca Ciocan, O., Doubek, M., Shvidel, L., Dali, N., Miras, F., De Meuter, A., Dimou, M., Mauro, F. R., Coscia, M., Bumbea, H., Szasz, R., Tadmor, T., Gutwein, O., Gentile, Marino, Scarfo, L., Tedeschi, Alessandra, Sportoletti, P., Gimeno Vazquez, E., Marquet, J., Assouline, S., Papaioannou, M., Braester, A., Levato, L., Gregor, M., Rigolin, G. M., Loscertales, J., Medina Perez, A., Nijziel, M. R., Popov, V. M., Collado, R., Slavutsky, I., Itchaki, G., Ringelstein, S., Goldschmidt, N., Perry, C., Levi, S., Polliack, A., Ghia, P., Laurenti L. (ORCID:0000-0002-8327-1396), Gentile M., Tedeschi A., Herishanu, Y., Shaulov, A., Fineman, R., Basic-Kinda, S., Aviv, A., Wasik-Szczepanek, E., Jaksic, O., Zdrenghea, M., Greenbaum, U., Mandac, I., Simkovic, M., Morawska, M., Benjamini, O., Spacek, M., Nemets, A., Bairey, O., Trentin, L., Ruchlemer, R., Laurenti, Luca, Stanca Ciocan, O., Doubek, M., Shvidel, L., Dali, N., Miras, F., De Meuter, A., Dimou, M., Mauro, F. R., Coscia, M., Bumbea, H., Szasz, R., Tadmor, T., Gutwein, O., Gentile, Marino, Scarfo, L., Tedeschi, Alessandra, Sportoletti, P., Gimeno Vazquez, E., Marquet, J., Assouline, S., Papaioannou, M., Braester, A., Levato, L., Gregor, M., Rigolin, G. M., Loscertales, J., Medina Perez, A., Nijziel, M. R., Popov, V. M., Collado, R., Slavutsky, I., Itchaki, G., Ringelstein, S., Goldschmidt, N., Perry, C., Levi, S., Polliack, A., Ghia, P., Laurenti L. (ORCID:0000-0002-8327-1396), Gentile M., and Tedeschi A.

Abstract

In recent years, considerable progress has been made in frontline therapy for elderly/physically unfit patients with CLL. The combination of obinutuzumab and chlorambucil (O-Clb) has been shown to prolong progression free survival (PFS, median PFS-31.5 months) and overall survival (OS) compared to chlorambucil alone. More recently, obinutuzumab given in combination with either ibrutinib or venetoclax improved PFS but not OS when compared to O-Clb. In this retrospective multinational, multicenter co-operative study, we evaluated the efficacy and safety of frontline treatment with O ± Clb in unfit patients with CLL, in a “real-world” setting. Patients with documented del (17p13.1)/TP53 mutation were excluded. A total of 437 patients (median age, 75.9 years; median CIRS score, 8; median creatinine clearance, 61.1 mL/min) were included. The clinical overall response rate was 80.3% (clinical complete and partial responses in 38.7% and 41.6% of patients, respectively). Median observation time was 14.1 months and estimated median PFS was 27.6 months (95% CI, 24.2-31.0). In a multivariate analysis, high-risk disease [del (11q22.3) and/or IGHV-unmutated], lymph nodes of diameter > 5 cm, obinutuzumab monotherapy and reduced cumulative dose of obinutuzumab, were all independently associated with shorter PFS. The median OS has not yet been reached and estimated 2-year OS is 88%. In conclusion, in a “real-world” setting, frontline treatment with O-Clb achieves PFS comparable to that reported in clinical trials. Inferior outcomes were noted in patients with del (11q22.3) and/or unmutated IGHV and those treated with obinutuzumab-monotherapy. Thus, O-Clb can be still considered as legitimate frontline therapy for unfit CLL patients with low-risk disease.

Published
2020

29. COVID-19 severity and mortality in patients with chronic lymphocytic leukemia: a joint study by ERIC, the European Research Initiative on CLL, and CLL Campus

Author

Scarfo, L., Chatzikonstantinou, T., Rigolin, G. M., Quaresmini, G., Motta, M., Vitale, C., Garcia-Marco, J. A., Hernandez-Rivas, J. A., Miras, F., Baile, M., Marquet, J., Niemann, C. U., Reda, G., Munir, T., Gimeno, E., Marchetti, M., Quaglia, F. M., Varettoni, M., Delgado, J., Iyengar, S., Janssens, A., Marasca, R., Ferrari, A., Cuellar-Garcia, C., Itchaki, G., Spacek, M., De Paoli, L., Laurenti, Luca, Levin, M. -D., Lista, E., Mauro, F. R., Simkovic, M., Van Der Spek, E., Vandenberghe, E., Trentin, L., Wasik-Szczepanek, E., Ruchlemer, R., Bron, D., De Paolis, M. R., Del Poeta, G., Farina, L., Foglietta, M., Gentile, Marino, Herishanu, Y., Herold, T., Jaksic, O., Kater, A. P., Kersting, S., Malerba, L., Orsucci, L., Popov, V. M., Sportoletti, P., Yassin, M., Pocali, B., Barna, G., Chiarenza, A., dos Santos, G., Nikitin, E., Andres, M., Dimou, M., Doubek, M., Enrico, A., Hakobyan, Y., Kalashnikova, O., Ortiz Pareja, M., Papaioannou, M., Rossi, Dario, Shah, N., Shrestha, A., Stanca, O., Stavroyianni, N., Strugov, V., Tam, C., Zdrenghea, M., Coscia, M., Stamatopoulos, K., Rossi, G., Rambaldi, A., Montserrat, E., Foa, Robin, Cuneo, A., Ghia, P., Laurenti L. (ORCID:0000-0002-8327-1396), Gentile M., Rossi D., Foa R., Scarfo, L., Chatzikonstantinou, T., Rigolin, G. M., Quaresmini, G., Motta, M., Vitale, C., Garcia-Marco, J. A., Hernandez-Rivas, J. A., Miras, F., Baile, M., Marquet, J., Niemann, C. U., Reda, G., Munir, T., Gimeno, E., Marchetti, M., Quaglia, F. M., Varettoni, M., Delgado, J., Iyengar, S., Janssens, A., Marasca, R., Ferrari, A., Cuellar-Garcia, C., Itchaki, G., Spacek, M., De Paoli, L., Laurenti, Luca, Levin, M. -D., Lista, E., Mauro, F. R., Simkovic, M., Van Der Spek, E., Vandenberghe, E., Trentin, L., Wasik-Szczepanek, E., Ruchlemer, R., Bron, D., De Paolis, M. R., Del Poeta, G., Farina, L., Foglietta, M., Gentile, Marino, Herishanu, Y., Herold, T., Jaksic, O., Kater, A. P., Kersting, S., Malerba, L., Orsucci, L., Popov, V. M., Sportoletti, P., Yassin, M., Pocali, B., Barna, G., Chiarenza, A., dos Santos, G., Nikitin, E., Andres, M., Dimou, M., Doubek, M., Enrico, A., Hakobyan, Y., Kalashnikova, O., Ortiz Pareja, M., Papaioannou, M., Rossi, Dario, Shah, N., Shrestha, A., Stanca, O., Stavroyianni, N., Strugov, V., Tam, C., Zdrenghea, M., Coscia, M., Stamatopoulos, K., Rossi, G., Rambaldi, A., Montserrat, E., Foa, Robin, Cuneo, A., Ghia, P., Laurenti L. (ORCID:0000-0002-8327-1396), Gentile M., Rossi D., and Foa R.

Abstract

Chronic lymphocytic leukemia (CLL) is a disease of the elderly, characterized by immunodeficiency. Hence, patients with CLL might be considered more susceptible to severe complications from COVID-19. We undertook this retrospective international multicenter study to characterize the course of COVID-19 in patients with CLL and identify potential predictors of outcome. Of 190 patients with CLL and confirmed COVID-19 diagnosed between 28/03/2020 and 22/05/2020, 151 (79%) presented with severe COVID-19 (need of oxygen and/or intensive care admission). Severe COVID-19 was associated with more advanced age (≥65 years) (odds ratio 3.72 [95% CI 1.79–7.71]). Only 60 patients (39.7%) with severe COVID-19 were receiving or had recent (≤12 months) treatment for CLL at the time of COVID-19 versus 30/39 (76.9%) patients with mild disease. Hospitalization rate for severe COVID-19 was lower (p < 0.05) for patients on ibrutinib versus those on other regimens or off treatment. Of 151 patients with severe disease, 55 (36.4%) succumbed versus only 1/38 (2.6%) with mild disease; age and comorbidities did not impact on mortality. In CLL, (1) COVID-19 severity increases with age; (2) antileukemic treatment (particularly BTK inhibitors) appears to exert a protective effect; (3) age and comorbidities did not impact on mortality, alluding to a relevant role of CLL and immunodeficiency.

Published
2020

30. Efficacy of bendamustine and rituximab in unfit patients with previously untreated chronic lymphocytic leukemia. Indirect comparison with ibrutinib in a real-world setting. A GIMEMA-ERIC and US study

Author

Cuneo, A., Mato, A. R., Rigolin, G. M., Piciocchi, A., Gentile, Marino, Laurenti, Luca, Allan, J. N., Pagel, J. M., Brander, D. M., Hill, B. T., Winter, A., Lamanna, N., Tam, C. S., Jacobs, R., Lansigan, F., Barr, P. M., Shadman, M., Skarbnik, A. P., Pu, J. J., Sehgal, A. R., Schuster, S. J., Shah, N. N., Ujjani, C. S., Roeker, L., Orlandi, E. M., Billio, Atto, Trentin, L., Spacek, M., Marchetti, M., Tedeschi, Alessandra, Ilariucci, F., Gaidano, G., Doubek, M., Farina, L., Molica, Serena, Di Raimondo, F., Coscia, M., Mauro, F. R., de la Serna, J., Medina Perez, A., Ferrarini, I., Cimino, Giovanni, Cavallari, M., Cucci, R., Vignetti, M., Foa, Robin, Ghia, P., Gentile M., Laurenti L. (ORCID:0000-0002-8327-1396), Billio A., Tedeschi A., Molica S., Cimino G., Foa R., Cuneo, A., Mato, A. R., Rigolin, G. M., Piciocchi, A., Gentile, Marino, Laurenti, Luca, Allan, J. N., Pagel, J. M., Brander, D. M., Hill, B. T., Winter, A., Lamanna, N., Tam, C. S., Jacobs, R., Lansigan, F., Barr, P. M., Shadman, M., Skarbnik, A. P., Pu, J. J., Sehgal, A. R., Schuster, S. J., Shah, N. N., Ujjani, C. S., Roeker, L., Orlandi, E. M., Billio, Atto, Trentin, L., Spacek, M., Marchetti, M., Tedeschi, Alessandra, Ilariucci, F., Gaidano, G., Doubek, M., Farina, L., Molica, Serena, Di Raimondo, F., Coscia, M., Mauro, F. R., de la Serna, J., Medina Perez, A., Ferrarini, I., Cimino, Giovanni, Cavallari, M., Cucci, R., Vignetti, M., Foa, Robin, Ghia, P., Gentile M., Laurenti L. (ORCID:0000-0002-8327-1396), Billio A., Tedeschi A., Molica S., Cimino G., and Foa R.

Abstract

Limited information is available on the efficacy of front-line bendamustine and rituximab (BR) in chronic lymphocytic leukemia (CLL) with reduced renal function or coexisting conditions. We therefore analyzed a cohort of real-world patients and performed a matched adjusted indirect comparison with a cohort of patients treated with ibrutinib. One hundred and fifty-seven patients with creatinine clearance (CrCl) <70 mL/min and/or CIRS score >6 were treated with BR. The median age was 72 years; 69% of patients had ≥2 comorbidities and the median CrCl was 59.8 mL/min. 17.6% of patients carried TP53 disruption. The median progression-free survival (PFS) was 45 months; TP53 disruption was associated with a shorter PFS (P = 0.05). The overall survival (OS) at 12, 24, and 36 months was 96.2%, 90.1%, and 79.5%, respectively. TP53 disruption was associated with an increased risk of death (P = 0.01). Data on 162 patients ≥65 years treated with ibrutinib were analyzed and compared with 165 patients ≥65 years treated with BR. Factors predicting for a longer PFS at multivariable analysis in the total patient population treated with BR and ibrutinib were age (HR 1.06, 95% CI 1.02-1.10, P < 0.01) and treatment with ibrutinib (HR 0.55, 95% CI 0.33-0.93, P = 0.03). In a post hoc analysis of patients in advanced stage, a significant PFS advantage was observed in patient who had received ibrutinib (P = 0.03), who showed a trend for OS advantage (P = 0.08). We arrived at the following conclusions: (a) BR is a relatively effective first-line regimen in a real-world population of unfit patients without TP53 disruption, (b) ibrutinib provided longer disease control than BR in patients with advanced disease stage.

Published
2020

31. Front-Line Therapy for Elderly Chronic Lymphocytic Leukemia Patients: Bendamustine Plus Rituximab or Chlorambucil Plus Rituximab? Real-Life Retrospective Multicenter Study in the Lazio Region

Author

Autore, Francesco, Innocenti, Idanna, Corrente, Francesco, Del Principe, M. I., Rosati, S., Falcucci, P., Fresa, Alberto, Conte, Eliana, Limongiello, M. A., Renzi, D., De Padua, L., Andriani, A., Pisani, F., Cimino, G., Tafuri, A., Montanaro, M., Mauro, F. R., Del Poeta, G., Laurenti, Luca, Autore F., Innocenti I., Corrente F., Fresa A., Conte E., Laurenti L. (ORCID:0000-0002-8327-1396), Autore, Francesco, Innocenti, Idanna, Corrente, Francesco, Del Principe, M. I., Rosati, S., Falcucci, P., Fresa, Alberto, Conte, Eliana, Limongiello, M. A., Renzi, D., De Padua, L., Andriani, A., Pisani, F., Cimino, G., Tafuri, A., Montanaro, M., Mauro, F. R., Del Poeta, G., Laurenti, Luca, Autore F., Innocenti I., Corrente F., Fresa A., Conte E., and Laurenti L. (ORCID:0000-0002-8327-1396)

Abstract

Previous studies investigated the efficacy and the safety of bendamustine (B) vs. chlorambucil (Chl) associated with rituximab (R) in fludarabine-ineligible patients with treated and untreated chronic lymphocytic leukemia (CLL). We conducted a retrospective multicenter study in the Lazio region to further evaluate and compare the efficacy and the toxicity of Chl-R and B-R regimen in CLL patients over the age of 65. We enrolled 192 untreated CLL patients: 111 treated with B-R and 81 with Chl-R. The overall response rates (ORR; 93.6% in B-R and 86.5% in Chl-R) were not statistically different between the two groups, such as progression-free survival (PFS), time to retreatment (TTR), and overall survival (OS). The B-R group showed a higher hematological (p = 0.007) and extra-hematological (p = 0.008) toxicity. When comparing the toxicities according to age, we noted that the extra-hematological toxicity was higher in patients over the age of 75 who were treated with B-R than those treated with Chl-R (p = 0.03). This retrospective study confirms the feasibility of B-R and Chl-R in elderly untreated CLL patients. Currently, patients who are over 75 and unfit are usually treated with Chl-R. This scheme allows achieving the same ORR, PFS, TTR, and OS when compared with B-R because of hematological and extra-hematological toxicities due to B, in which a greater dose reduction has been shown in comparison to Chl.

Published
2020

34. TP53 disruption as a risk factor in the era of targeted therapies: A multicenter retrospective study of 525 chronic lymphocytic leukemia cases

Author

Morabito, Francesco, Del Poeta, G., Mauro, F. R., Reda, G., Sportoletti, P., Laurenti, Luca, Coscia, M., Herishanu, Y., Bossio, S., Varettoni, M., Murru, R., Chiarenza, A., Visentin, A., Condoluci, A., Moia, R., Pietrasanta, D., Loseto, G., Consoli, U., Scortechini, I., Recchia, A. G., Rossi, Federica Maria, Zucchetto, A., Al-Janazreh, H., Martino, E. A., Vigna, E., Tripepi, G., D'Arrigo, G., Galimberti, Sofia, Rago, A., Angeletti, I., Biagi, A., Del Giudice, I., Bomben, R., Neri, A., Fronza, G., Cutrona, G., Jaksic, O., Olivieri, J., Rossi, Dario, Di Raimondo, F., Cuneo, A., Gaidano, G., Polliack, A., Trentin, L., Foa, Robin, Ferrarini, M., Gattei, V., Gentile, Marino, Morabito F., Laurenti L. (ORCID:0000-0002-8327-1396), Rossi F. M., Galimberti S., Rossi D., Foa R., Gentile M., Morabito, Francesco, Del Poeta, G., Mauro, F. R., Reda, G., Sportoletti, P., Laurenti, Luca, Coscia, M., Herishanu, Y., Bossio, S., Varettoni, M., Murru, R., Chiarenza, A., Visentin, A., Condoluci, A., Moia, R., Pietrasanta, D., Loseto, G., Consoli, U., Scortechini, I., Recchia, A. G., Rossi, Federica Maria, Zucchetto, A., Al-Janazreh, H., Martino, E. A., Vigna, E., Tripepi, G., D'Arrigo, G., Galimberti, Sofia, Rago, A., Angeletti, I., Biagi, A., Del Giudice, I., Bomben, R., Neri, A., Fronza, G., Cutrona, G., Jaksic, O., Olivieri, J., Rossi, Dario, Di Raimondo, F., Cuneo, A., Gaidano, G., Polliack, A., Trentin, L., Foa, Robin, Ferrarini, M., Gattei, V., Gentile, Marino, Morabito F., Laurenti L. (ORCID:0000-0002-8327-1396), Rossi F. M., Galimberti S., Rossi D., Foa R., and Gentile M.

Abstract

n/a

Published
2019

39. Refined karyotype-based prognostic stratification of chronic lymphocytic leukemia with a low-and very-low-risk genetic profile

Author

Giudice, I Del, Rigolin, G. M., Raponi, S., Cafforio, L., Ilari, C., Wang, Jiguang, Bordyuh, M., Piciocchi, A., Marinelli, M., Nanni, M., Tavolaro, S., Filetti, M., Bardi, A., Tammiso, E., Volta, E., Negrini, M., Saccenti, E., Mauro, F. R., Rossi, D., Gaidano, G., Guarini, A., Rabadan, R., Cuneo, A., Foà, R., Giudice, I Del, Rigolin, G. M., Raponi, S., Cafforio, L., Ilari, C., Wang, Jiguang, Bordyuh, M., Piciocchi, A., Marinelli, M., Nanni, M., Tavolaro, S., Filetti, M., Bardi, A., Tammiso, E., Volta, E., Negrini, M., Saccenti, E., Mauro, F. R., Rossi, D., Gaidano, G., Guarini, A., Rabadan, R., Cuneo, A., and Foà, R.

Published
2018

40. LDH AS PREDICTIVE PARAMETER IN TREATMENT-NAIVE PATIENTS WITH TRISOMY 12 CHRONIC LYMPHOCYTIC LEUKEMIA

Author

Autore, F., Strati, P., Innocenti, I., Corrente, F., Trentin, L., Cortelezzi, A., Visco, C., Coscia, M., Cuneo, A., Gozzetti, A., Mauro, F. R., Montillo, M., Gentile, M., Morabito, F., Molica, S., Falcucci, P., D Arena, G., Murru, R., Vincelli, D., Galieni, P., Reda, G., Maria Chiara Tisi, Vitale, C., Rigolin, G. M., Ferrajoli, A., and Laurenti, L.

Subjects
trisomy 12, LDH, prognosis, CLL, trisomy 12, prognosis, LDH, CLL, NO
Published
2017

41. AB0163 Increased eryptosis levels in erythrocytes treated with antibodies from aps patients: eryptosis as new actor in aps pathogenesis

Author

Vomero, M., primary, Ceccarelli, F., additional, Finucci, A., additional, Barbati, C., additional, Colasanti, T., additional, Pensa, C., additional, Spinelli, F. R., additional, Perricone, C., additional, Novelli, L., additional, Massaro, L., additional, Mauro, F. R., additional, Foà, R., additional, Conti, F., additional, Valesini, G., additional, and Alessandri, C., additional

Published
2018
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42. Refined karyotype-based prognostic stratification of chronic lymphocytic leukemia with a low- and very-low-risk genetic profile

Author

Giudice, I Del, primary, Rigolin, G M, additional, Raponi, S, additional, Cafforio, L, additional, Ilari, C, additional, Wang, J, additional, Bordyuh, M, additional, Piciocchi, A, additional, Marinelli, M, additional, Nanni, M, additional, Tavolaro, S, additional, Filetti, M, additional, Bardi, A, additional, Tammiso, E, additional, Volta, E, additional, Negrini, M, additional, Saccenti, E, additional, Mauro, F R, additional, Rossi, D, additional, Gaidano, G, additional, Guarini, A, additional, Rabadan, R, additional, Cuneo, A, additional, and Foà, R, additional

Published
2017
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43. A GLOBAL PROGRESSION RISK SCORE FOR EARLY STAGE CHRONIC LYMPHOCYTIC LEUKEMIA PATIENTS: THE NEVER-ENDING STORY

Author

Gentile, M., Shanafelt, T. D., Giovanna Cutrona, Molica, S., Tripepi, G., Ilariucci, F., Mauro, F. R., Di Renzo, N., Di Raimondo, F., Vincelli, I., Todoerti, K., Matis, S., Musolino, C., Maura, F., Fabris, S., Lionetti, M., Levato, L., Zupo, S., Angrilli, F., Consoli, U., Festini, G., Longo, G., Cortelezzi, A., Musto, P., Federico, M., Mannina, D., Neri, A., Kay, N. E., Ferrarini, M., and Morabito, F.

Published
2015

45. A progression-risk score to predict treatment-free survival for early stage chronic lymphocytic leukemia patients

Author

Gentile, M, primary, Shanafelt, T D, additional, Cutrona, G, additional, Molica, S, additional, Tripepi, G, additional, Alvarez, I, additional, Mauro, F R, additional, Di Renzo, N, additional, Di Raimondo, F, additional, Vincelli, I, additional, Todoerti, K, additional, Matis, S, additional, Musolino, C, additional, Fabris, S, additional, Vigna, E, additional, Levato, L, additional, Zupo, S, additional, Angrilli, F, additional, Consoli, U, additional, Festini, G, additional, Longo, G, additional, Cortelezzi, A, additional, Arcari, A, additional, Federico, M, additional, Mannina, D, additional, Recchia, A G, additional, Neri, A, additional, Kay, N E, additional, Ferrarini, M, additional, and Morabito, F, additional

Published
2015
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47. INCLUSION OF TOTAL BODY CT SCAN IN THE INITIAL WORK-UP OF CLL PATIENTS WITH EARLY-STAGE ON CLINICAL GROUNDS: PRELIMINARY RESULTS OF A PROSPECTIVE, MULTICENTER O-CLL1- GISL STUDY

Author

Gentile, M., Giovanna Cutrona, Fabris, S., Pesce, E., Di Raimondo, F., Di Renzo, N., Mauro, F. R., Cantaffa, R., Brugiatelli, M., Merli, F., Baldini, L., Quintana, G., Iannitto, E., Di Tonno, P., Fragasso, A., Molica, S., Callea, V., Sacchi, S., Federico, M., Neri, A., Ferrarini, M., and Morabito, F.

Subjects
nd
Published
2009

48. INCIDENCE OF CYTOGENETIC ABNORMALITIES IN NEWLY DIAGNOSED BINET STAGE A B-CLL AND RELATIONSHIP WITH PROGNSOTIC BIOMARKERS: PRELIMINARY RESULTS ON 240 PATIENTS INCLUDED IN THE PROSPECTIVE, MULTICENTER O-CLL1 GISL STUDY

Author

Fabris, S, Cutrona, G, Gentile, M, Matis, S, Pesce, E. A., DI RAIMONDO, Francesco, Musolino, C, Gobbi, M, DI RENZO, N, Mauro, F. R., Cantaffa, R, Brugiatelli, M, Merli, F, Zupo, S, Mammi, C, Baldini, L, Angrilli, F, Quintana, G, Consoli, U, Bertoldero, G, Iannitto, E, DI TONNO, P, Fragasso, A, Molica, S, Musto, P, Cox, M. C., Festini, G, Callea, V, Sacchi, S, Cortellezzi, A, LAMBERTENGHI DELILIERS, G, FEDERICO M, FOÀ R., Ferrarini, M, Morabito, F, and Neri, A.

Published
2009

49. Efficacy and Safety of a First-Line Combined Therapeutic Approach for Young CLL Patients Stratified According to the Biological Prognostic Features: First Analysis of the GIMEMA Multicenter LLC0405 Study

Author

Mauro, F. R., Cortelezzi, A., Molica, S., Laurenti, L., Liso, V., Rizzi, R., Carella, A. M., DI RAIMONDO, Francesco, Marasca, R., Fioritoni, G., Brugiatelli, M., Musolino, C., Lauria, F., Buccisano, F., Zaja, F., Callea, V., Morabito, F., Massaia, M., Gentile, G., DEL GIUDICE, I., DE PROPRIS, M. S., DELLA STARZA, I., Marinelli, M., Santangelo, S., Nanni, M., Vignetti, M., Graziosi, A., Specchia, G., Cuneo, A., Guarini, A., Blood, AND R. FOÀ ., and Vol, P.

Published
2008

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