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1. A phase 1/2 clinical trial of invariant natural killer T cell therapy in moderate-severe acute respiratory distress syndrome

Author

Hammond, Terese C., Purbhoo, Marco A., Kadel, Sapana, Ritz, Jerome, Nikiforow, Sarah, Daley, Heather, Shaw, Kit, van Besien, Koen, Gomez-Arteaga, Alexandra, Stevens, Don, Ortuzar, Waldo, Michelet, Xavier, Smith, Rachel, Moskowitz, Darrian, Masakayan, Reed, Yigit, Burcu, Boi, Shannon, Soh, Kah Teong, Chamberland, John, Song, Xin, Qin, Yu, Mishchenko, Ilya, Kirby, Maurice, Nasonenko, Valeriia, Buffa, Alexa, Buell, Jennifer S., Chand, Dhan, van Dijk, Marc, Stebbing, Justin, and Exley, Mark A.

Published
2024
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3. Elranatamab in relapsed or refractory multiple myeloma: phase 2 MagnetisMM-3 trial results

Author

Lesokhin, Alexander M., Tomasson, Michael H., Arnulf, Bertrand, Bahlis, Nizar J., Miles Prince, H., Niesvizky, Ruben, Rodrίguez-Otero, Paula, Martinez-Lopez, Joaquin, Koehne, Guenther, Touzeau, Cyrille, Jethava, Yogesh, Quach, Hang, Depaus, Julien, Yokoyama, Hisayuki, Gabayan, Afshin Eli, Stevens, Don A., Nooka, Ajay K., Manier, Salomon, Raje, Noopur, Iida, Shinsuke, Raab, Marc-Steffen, Searle, Emma, Leip, Eric, Sullivan, Sharon T., Conte, Umberto, Elmeliegy, Mohamed, Czibere, Akos, Viqueira, Andrea, and Mohty, Mohamad

Published
2023
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5. Venetoclax combinations delay the time to deterioration of HRQoL in unfit patients with acute myeloid leukemia

Author

Pratz, Keith W, Panayiotidis, Panayiotis, Recher, Christian, Wei, Xudong, Jonas, Brian A, Montesinos, Pau, Ivanov, Vladimir, Schuh, Andre C, DiNardo, Courtney D, Novak, Jan, Pejsa, Vlatko, Stevens, Don, Yeh, Su-Peng, Kim, Inho, Turgut, Mehmet, Fracchiolla, Nicola, Yamamoto, Kazuhito, Ofran, Yishai, Wei, Andrew H, Bui, Cat N, Benjamin, Katy, Kamalakar, Rajesh, Potluri, Jalaja, Mendes, Wellington, Devine, Jacob, and Fiedler, Walter

Subjects
Biomedical and Clinical Sciences, Cardiovascular Medicine and Haematology, Oncology and Carcinogenesis, Clinical Research, Rare Diseases, Cancer, Antineoplastic Combined Chemotherapy Protocols, Bridged Bicyclo Compounds, Heterocyclic, Cytarabine, Fatigue, Humans, Leukemia, Myeloid, Acute, Quality of Life, Sulfonamides, Cardiorespiratory Medicine and Haematology, Cardiovascular medicine and haematology, Oncology and carcinogenesis
Abstract

Phase 3 trials Viale-A and Viale-C evaluated health-related quality of life (HRQoL) in patients with AML unfit for intensive chemotherapy who received venetoclax (VEN) + (AZA) (Viale-A) or low-dose cytarabine (LDAC) (Viale-C) or placebo (PBO) + AZA or LDAC. Patient-reported outcomes included: EORTC QLQ-C30 global health status (GHS/QoL) and physical functioning (PF), PROMIS Cancer Fatigue Short Form 7a (Fatigue), and EQ-5D-5L health status visual analog scale (HS-VAS). Time to deterioration (TTD), defined as worsening from baseline in meaningful change thresholds (MCT) of ≥10, 5, or 7 points for GHS/QoL or PF, fatigue, and HS-VAS, respectively, was assessed; differences between groups were analyzed using Kaplan-Meier and unadjusted log-rank analyses. VEN + AZA vs PBO + AZA patients had longer TTD in GHS/QoL (P = 0.066) and fatigue (P = 0.189), and significantly longer TTD in PF (P = 0.028) and HS-VAS (P MCT in GHS/QoL. Overall, VEN may positively impact HRQoL in patients with AML ineligible for intensive chemotherapy, leading to longer preservation of functioning and overall health status.

Published
2022

6. Selinexor, bortezomib, and dexamethasone versus bortezomib and dexamethasone in previously treated multiple myeloma: Outcomes by cytogenetic risk.

Author

Richard, Shambavi, Chari, Ajai, Delimpasi, Sosana, Simonova, Maryana, Spicka, Ivan, Pour, Ludek, Kriachok, Iryna, Dimopoulos, Meletios, Pylypenko, Halyna, Auner, Holger, Leleu, Xavier, Usenko, Ganna, Hajek, Roman, Benjamin, Reuben, Dolai, Tuphan, Sinha, Dinesh, Venner, Christopher, Garg, Mamta, Stevens, Don, Quach, Hang, Jagannath, Sundar, Moreau, Phillipe, Levy, Moshe, Badros, Ashraf, Anderson, Larry, Bahlis, Nizar, Facon, Thierry, Mateos, Maria, Cavo, Michele, Chang, Hua, Landesman, Yosef, Chai, Yi, Arazy, Melina, Shah, Jatin, Shacham, Sharon, Kauffman, Michael, Grosicki, Sebastian, and Richardson, Paul

Subjects
Adult, Aged, Antineoplastic Agents, Antineoplastic Combined Chemotherapy Protocols, Bortezomib, Cytogenetic Analysis, Dexamethasone, Female, Humans, Hydrazines, Male, Middle Aged, Multiple Myeloma, Progression-Free Survival, Treatment Outcome, Triazoles, Young Adult
Abstract

In the phase 3 BOSTON study, patients with multiple myeloma (MM) after 1-3 prior regimens were randomized to once-weekly selinexor (an oral inhibitor of exportin 1 [XPO1]) plus bortezomib-dexamethasone (XVd) or twice-weekly bortezomib-dexamethasone (Vd). Compared with Vd, XVd was associated with significant improvements in median progression-free survival (PFS), overall response rate (ORR), and lower rates of peripheral neuropathy, with trends in overall survival (OS) favoring XVd. In BOSTON, 141 (35.1%) patients had MM with high-risk (presence of del[17p], t[4;14], t[14;16], or ≥4 copies of amp1q21) cytogenetics (XVd, n = 70; Vd, n = 71), and 261 (64.9%) exhibited standard-risk cytogenetics (XVd, n = 125; Vd, n = 136). Among patients with high-risk MM, median PFS was 12.91 months for XVd and 8.61 months for Vd (HR, 0.73 [95% CI, (0.4673, 1.1406)], p = 0.082), and ORRs were 78.6% and 57.7%, respectively (OR 2.68; p = 0.004). In the standard-risk subgroup, median PFS was 16.62 months for XVd and 9.46 months for Vd (HR 0.61; p = 0.004), and ORRs were 75.2% and 64.7%, respectively (OR 1.65; p = 0.033). The safety profiles of XVd and Vd in both subgroups were consistent with the overall population. These data suggest that selinexor can confer benefits to patients with MM regardless of cytogenetic risk. ClinicalTrials.gov identifier: NCT03110562.

Published
2021

7. Safety and efficacy of tafasitamab with or without lenalidomide added to first-line R-CHOP for DLBCL: the phase 1b First-MIND study

Author

Belada, David, Kopeckova, Katerina, Bergua Burgues, Juan Miguel, Stevens, Don, André, Marc, Persona, Ernesto Perez, Pichler, Petra, Staber, Philipp B., Trneny, Marek, Duell, Johannes, Waldron-Lynch, Maeve, Wagner, Steve, Mukhopadhyay, Amitava, Dirnberger-Hertweck, Maren, Burke, John M., and Nowakowski, Grzegorz S.

Published
2023
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8. Single-agent ibrutinib versus chemoimmunotherapy regimens for treatment-naïve patients with chronic lymphocytic leukemia: A cross-trial comparison of phase 3 studies.

Author

Robak, Tadeusz, Burger, Jan A, Tedeschi, Alessandra, Barr, Paul M, Owen, Carolyn, Bairey, Osnat, Hillmen, Peter, Simpson, David, Grosicki, Sebastian, Devereux, Stephen, McCarthy, Helen, Coutre, Steven E, Quach, Hang, Gaidano, Gianluca, Maslyak, Zvenyslava, Stevens, Don A, Moreno, Carol, Gill, Devinder S, Flinn, Ian W, Gribben, John G, Mokatrin, Ahmad, Cheng, Mei, Styles, Lori, James, Danelle F, Kipps, Thomas J, and Ghia, Paolo

Subjects
Humans, Pyrazoles, Pyrimidines, Antineoplastic Combined Chemotherapy Protocols, Treatment Outcome, Immunotherapy, Survival Analysis, Retrospective Studies, Aged, Middle Aged, Female, Male, Clinical Trials as Topic, Leukemia, Lymphocytic, Chronic, B-Cell, Cancer, Clinical Trials and Supportive Activities, Lymphoma, Rare Diseases, Clinical Research, Hematology, 6.1 Pharmaceuticals, Immunology, Cardiorespiratory Medicine and Haematology
Abstract

Chemoimmunotherapy (CIT) and targeted therapy with single-agent ibrutinib are both recommended first-line treatments for chronic lymphocytic leukemia (CLL), although their outcomes have not been directly compared. Using ibrutinib data from the RESONATE-2 (PCYC-1115/1116) study conducted in patients ≥65 years without del(17p), we performed a cross-trial comparison with CIT data from published phase 3 studies in first-line treatment of CLL. Progression-free survival (PFS), overall survival (OS), and safety data for ibrutinib (median follow-up 35.7 months) were evaluated alongside available CIT data. CIT regimens included: fludarabine + cyclophosphamide + rituximab (CLL8, CLL10), bendamustine + rituximab (CLL10), obinutuzumab + chlorambucil and rituximab + chlorambucil (CLL11), and ofatumumab + chlorambucil (COMPLEMENT-1). Median age across studies was 61-74 years, with older populations receiving ibrutinib, obinutuzumab + chlorambucil, or rituximab + chlorambucil. Median follow-up varied across studies/regimens (range 14.5-37.4 months). Among all patients, PFS appeared longer with ibrutinib relative to CIT and OS appeared comparable. Relative to CIT studies that similarly excluded patients with del(17p) (CLL10) or enrolled older/less-fit patients (CLL11), PFS appeared favorable for ibrutinib in high-risk subgroups, including advanced disease, bulky lymph nodes, unmutated IGHV status, and presence of del(11q). Grade ≥ 3 infections ranged from 9% (ofatumumab + chlorambucil) to 40% (fludarabine + cyclophosphamide + rituximab), and was 25% with ibrutinib. Grade ≥ 3 neutropenia was 12% for ibrutinib and 26%-84% for CIT. Although definitive conclusions cannot be made due to inherent limitations of cross-trial comparisons, this report suggests that ibrutinib has a favorable benefit/risk profile and may potentially eliminate the need for chemotherapy in some patients. Randomized, comparative studies are needed to support these findings.

Published
2018

11. Venetoclax plus LDAC for newly diagnosed AML ineligible for intensive chemotherapy: a phase 3 randomized placebo-controlled trial

Author

Wei, Andrew H., Montesinos, Pau, Ivanov, Vladimir, DiNardo, Courtney D., Novak, Jan, Laribi, Kamel, Kim, Inho, Stevens, Don A., Fiedler, Walter, Pagoni, Maria, Samoilova, Olga, Hu, Yu, Anagnostopoulos, Achilles, Bergeron, Julie, Hou, Jing-Zhou, Murthy, Vidhya, Yamauchi, Takahiro, McDonald, Andrew, Chyla, Brenda, Gopalakrishnan, Sathej, Jiang, Qi, Mendes, Wellington, Hayslip, John, and Panayiotidis, Panayiotis

Published
2020
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12. Ibrutinib as Initial Therapy for Patients with Chronic Lymphocytic Leukemia

Author

Burger, Jan A, Tedeschi, Alessandra, Barr, Paul M, Robak, Tadeusz, Owen, Carolyn, Ghia, Paolo, Bairey, Osnat, Hillmen, Peter, Bartlett, Nancy L, Li, Jianyong, Simpson, David, Grosicki, Sebastian, Devereux, Stephen, McCarthy, Helen, Coutre, Steven, Quach, Hang, Gaidano, Gianluca, Maslyak, Zvenyslava, Stevens, Don A, Janssens, Ann, Offner, Fritz, Mayer, Jiří, O'Dwyer, Michael, Hellmann, Andrzej, Schuh, Anna, Siddiqi, Tanya, Polliack, Aaron, Tam, Constantine S, Suri, Deepali, Cheng, Mei, Clow, Fong, Styles, Lori, James, Danelle F, and Kipps, Thomas J

Subjects
Biomedical and Clinical Sciences, Cardiovascular Medicine and Haematology, Oncology and Carcinogenesis, Clinical Research, Lymphoma, Hematology, Orphan Drug, Cancer, Rare Diseases, Clinical Trials and Supportive Activities, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Adenine, Aged, Antineoplastic Agents, Chlorambucil, Diarrhea, Disease-Free Survival, Fatigue, Female, Humans, Leukemia, Lymphocytic, Chronic, B-Cell, Male, Neutropenia, Piperidines, Pyrazoles, Pyrimidines, Survival Analysis, RESONATE-2 Investigators, Medical and Health Sciences, General & Internal Medicine, Biomedical and clinical sciences, Health sciences
Abstract

BackgroundChronic lymphocytic leukemia (CLL) primarily affects older persons who often have coexisting conditions in addition to disease-related immunosuppression and myelosuppression. We conducted an international, open-label, randomized phase 3 trial to compare two oral agents, ibrutinib and chlorambucil, in previously untreated older patients with CLL or small lymphocytic lymphoma.MethodsWe randomly assigned 269 previously untreated patients who were 65 years of age or older and had CLL or small lymphocytic lymphoma to receive ibrutinib or chlorambucil. The primary end point was progression-free survival as assessed by an independent review committee.ResultsThe median age of the patients was 73 years. During a median follow-up period of 18.4 months, ibrutinib resulted in significantly longer progression-free survival than did chlorambucil (median, not reached vs. 18.9 months), with a risk of progression or death that was 84% lower with ibrutinib than that with chlorambucil (hazard ratio, 0.16; P

Published
2015

13. Effect of prior treatments on selinexor, bortezomib, and dexamethasone in previously treated multiple myeloma

Author

Mateos, Maria V., Gavriatopoulou, Maria, Facon, Thierry, Auner, Holger W., Leleu, Xavier, Hájek, Roman, Dimopoulos, Meletios A., Delimpasi, Sosana, Simonova, Maryana, Špička, Ivan, Pour, Ludĕk, Kriachok, Iryna, Pylypenko, Halyna, Doronin, Vadim, Usenko, Ganna, Benjamin, Reuben, Dolai, Tuphan K., Sinha, Dinesh K., Venner, Christopher P., Garg, Mamta, Stevens, Don A., Quach, Hang, Jagannath, Sundar, Moreau, Philippe, Levy, Moshe, Badros, Ashraf Z., Anderson, Jr., Larry D., Bahlis, Nizar J., Cavo, Michele, Chai, Yi, Jeha, Jacqueline, Arazy, Melina, Shah, Jatin, Shacham, Sharon, Kauffman, Michael G., Richardson, Paul G., and Grosicki, Sebastian

Published
2021
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14. Author Correction: 6-month follow-up of VIALE-C demonstrates improved and durable efficacy in patients with untreated AML ineligible for intensive chemotherapy

Author

Wei, Andrew H., Panayiotidis, Panayiotis, Montesinos, Pau, Laribi, Kamel, Ivanov, Vladimir, Kim, Inho, Novak, Jan, Stevens, Don A., Fiedler, Walter, Pagoni, Maria, Bergeron, Julie, Ting, Stephen B., Hou, Jing-Zhou, Anagnostopoulos, Achilles, McDonald, Andrew, Murthy, Vidhya, Yamauchi, Takahiro, Wang, Jianxiang, Chyla, Brenda, Sun, Yan, Jiang, Qi, Mendes, Wellington, Hayslip, John, and DiNardo, Courtney D.

Published
2021
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15. 6-month follow-up of VIALE-C demonstrates improved and durable efficacy in patients with untreated AML ineligible for intensive chemotherapy

Author

Wei, Andrew H., Panayiotidis, Panayiotis, Montesinos, Pau, Laribi, Kamel, Ivanov, Vladimir, Kim, Inho, Novak, Jan, Stevens, Don A., Fiedler, Walter, Pagoni, Maria, Bergeron, Julie, Ting, Stephen B., Hou, Jing-Zhou, Anagnostopoulos, Achilles, McDonald, Andrew, Murthy, Vidhya, Yamauchi, Takahiro, Wang, Jianxiang, Chyla, Brenda, Sun, Yan, Jiang, Qi, Mendes, Wellington, Hayslip, John, and DiNardo, Courtney D.

Published
2021
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17. S101: OMISSION OF RADIOTHERAPY IN PRIMARY MEDIASTINAL B-CELL LYMPHOMA PATIENTS FOLLOWING COMPLETE METABOLIC RESPONSE TO STANDARD IMMUNOCHEMOTHERAPY: RESULTS OF THE IELSG37 RANDOMISED TRIAL (NCT01599559)

Author

Martelli, Maurizio, primary, Ceriani, Luca, additional, Zucca, Emanuele, additional, Kryachok, Irina, additional, Ciccone, Giovannino, additional, Ricardi, Umberto, additional, Botto, Barbara, additional, Balzarotti, Monica, additional, Tucci, Alessandra, additional, Veronica Usai, Sara, additional, Pennese, Elsa, additional, Arcaini, Luca, additional, Dabrowska-Iwanicka, Anna, additional, José María Ferreri, Andrés, additional, Marli, Francesco, additional, Zhao, Weili, additional, Hodgson, David, additional, Ionescu, Codruta, additional, Rigacci, Luigi, additional, Cellini, Claudia, additional, Stelitano, Caterina, additional, Zaja, Francesco, additional, Guarini, Attilio, additional, Spina, Michele, additional, Fossa, Alexander, additional, Cwynarski, Kate, additional, Mikhaeel, N. George, additional, Jerkeman, Mats, additional, Janíková, Andrea, additional, Huettmann, Andreas, additional, Silva, Maria Gomes Da, additional, Stevens, Don, additional, Petrucci, Luigi, additional, Barrington, Sally, additional, Malkowski, Bogdan, additional, Metser, Ur, additional, Versari, Annibale, additional, Bagni, Oreste, additional, Chauvie, Stephane, additional, Cozens, Kelly, additional, Perticone, Sonia, additional, Ielmini, Nicoletta, additional, Cavalli, Franco, additional, Gosodarowicz, Mary, additional, Johnson, Peter W., additional, and Davies, Andrew, additional

Published
2023
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18. P1125: DURABLES RESPONSES ACHIEVED WITH ANTI-CD19 ALLOGENEIC CAR T ALLO-501/501A IN PHASE 1 TRIALS OF AUTOLOGOUS CAR T-NAÏVE PATIENTS WITH RELAPSED/REFRACTORY LARGE B-CELL LYMPHOMA (R/R LBCL)

Author

Munoz, Javier, primary, Locke, Frederick, additional, Lekakis, Lazaros, additional, Eradat, Herbert, additional, Tees, Michael, additional, de Vos, Sven, additional, Nath, Rajneesh, additional, Stevens, Don, additional, Malik, Shahbaz, additional, Popplewell, Leslie, additional, Hamadani, Mehdi, additional, Oluwole, Olalekan, additional, Perales, Miguel-Angel, additional, Miklos, David, additional, Fisher, Paul, additional, Goyal, Lovely, additional, Navale, Lynn, additional, Kaufman, Gregory, additional, Kai, Kazuharu, additional, Balakumaran, Arun, additional, and Neelapu, Sattva, additional

Published
2023
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19. P1094: SAFETY AND EFFICACY OF ACALABRUTINIB, BENDAMUSTINE, AND RITUXIMAB IN PATIENTS WITH TREATMENT-NAIVE OR RELAPSED/REFRACTORY MANTLE CELL LYMPHOMA: PHASE IB TRIAL

Author

Phillips, Tycel, primary, Wang, Michael, additional, Robak, Tadeusz, additional, Gallinson, David, additional, Stevens, Don, additional, Patel, Krish, additional, Ramadan, Safaa, additional, Wun, Chuan-Chaun, additional, Jurczak, Wojciech, additional, and Smith, Stephen D., additional

Published
2023
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20. P644: IBRUTINIB DOSE MODIFICATIONS FOR MANAGEMENT OF CARDIAC ADVERSE EVENTS IN PATIENTS WITH B-CELL MALIGNANCIES: POOLED ANALYSIS OF 10 CLINICAL TRIALS

Author

Stephens, Deborah, primary, R. Brown, Jennifer, additional, MA, Shuo, additional, Wang, Michael, additional, Moreno, Carol, additional, Robak, Tadeusz, additional, Stevens, Don, additional, Lee, Shane, additional, Saifan, Chadi, additional, Hsu, Emily, additional, Patel, Sima, additional, and Burger, Jan, additional

Published
2023
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21. S224: HIGH COMPLETE RESPONSE RATE WITH TNB-486, A NOVEL CD19XCD3 T-CELL ENGAGER, IN RELAPSED/REFRACTORY FOLLICULAR LYMPHOMA: INTERIM RESULTS FROM AN ONGOING PHASE 1 STUDY

Author

Jacobs, Ryan, primary, Nair, Ranjit, additional, Cho, Seok-Goo, additional, Devata, Sumana, additional, Gaballa, Sameh, additional, Yoon, Dok Hyun, additional, Stevens, Don, additional, Kim, Jin Seok, additional, Shah, Nirav N, additional, Brennan, Denise Marie, additional, Law, Jason, additional, Lesley, Robin, additional, Chen, Rob, additional, Forcina, Alessandra, additional, Buelow, Ben, additional, and Hou, Jing-Zhou, additional

Published
2023
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25. Impact of Minimal Residual Disease on Progression-Free Survival Outcomes after Fixed-Duration Ibrutinib-Venetoclax Versus Chlorambucil-Obinutuzumab in the GLOW Study

Author

Munir, Talha, Moreno, Carol, Owen, Carolyn, Follows, George, Benjamini, Ohad, Janssens, Ann, Levin, Mark David, Osterborg, Anders, Robak, Tadeusz, Simkovic, Martin, Stevens, Don, Voloshin, Sergey, Vorobyev, Vladimir, Yagci, Munci, Ysebaert, Loic, Qi, Keqin, Qi, Qianya, Parisi, Lori, Srinivasan, Srimathi, Schuier, Natasha, Baeten, Kurt, Howes, Angela, Caces, Donne Bennett, Niemann, Carsten U., Kater, Arnon P., Munir, Talha, Moreno, Carol, Owen, Carolyn, Follows, George, Benjamini, Ohad, Janssens, Ann, Levin, Mark David, Osterborg, Anders, Robak, Tadeusz, Simkovic, Martin, Stevens, Don, Voloshin, Sergey, Vorobyev, Vladimir, Yagci, Munci, Ysebaert, Loic, Qi, Keqin, Qi, Qianya, Parisi, Lori, Srinivasan, Srimathi, Schuier, Natasha, Baeten, Kurt, Howes, Angela, Caces, Donne Bennett, Niemann, Carsten U., and Kater, Arnon P.

Abstract

PURPOSE In GLOW, fixed-duration ibrutinib + venetoclax showed superior progression-free survival (PFS) versus chlorambucil + obinutuzumab in older/comorbid patients with previously untreated chronic lymphocytic leukemia (CLL). The current analysis describes minimal residual disease (MRD) kinetics and any potential predictive value for PFS, as it has not yet been evaluated for ibrutinib + venetoclax treatment. METHODS Undetectable MRD (uMRD) was assessed by next-generation sequencing at <1 CLL cell per 10,000 (<10−4) and <1 CLL cell per 100,000 (<10−5) leukocytes. PFS was analyzed by MRD status at 3 months after treatment (EOT+3). RESULTS Ibrutinib + venetoclax achieved deeper uMRD (<10−5) rates in bone marrow (BM) and peripheral blood (PB), respectively, in 40.6% and 43.4% of patients at EOT+3 versus 7.6% and 18.1% of patients receiving chlorambucil + obinutuzumab. Of these patients, uMRD (<10−5) in PB was sustained during the first year post-treatment (EOT+12) in 80.4% of patients receiving ibrutinib + venetoclax and 26.3% receiving chlorambucil + obinutuzumab. Patients with detectable MRD (dMRD; ≥10−4) in PB at EOT+3 were more likely to sustain MRD levels through EOT+12 with ibrutinib + venetoclax versus chlorambucil + obinutuzumab. PFS rates at EOT+12 were high among patients treated with ibrutinib + venetoclax regardless of MRD status at EOT+3: 96.3% and 93.3% in patients with uMRD (<10−4) and dMRD (≥10−4) in BM, respectively, versus 83.3% and 58.7% for patients receiving chlorambucil + obinutuzumab. PFS rates at EOT+12 also remained high in patients with unmutated immunoglobulin heavy-chain variable region (IGHV) receiving ibrutinib + venetoclax, independent of MRD status in BM. CONCLUSION Molecular and clinical relapses were less frequent during the first year post-treatment with ibrutinib + venetoclax versus chlorambucil + obinutuzumab regardless of MRD status at EOT+3 and IGHV status. Even for p, PURPOSEIn GLOW, fixed-duration ibrutinib + venetoclax showed superior progression-free survival (PFS) versus chlorambucil + obinutuzumab in older/comorbid patients with previously untreated chronic lymphocytic leukemia (CLL). The current analysis describes minimal residual disease (MRD) kinetics and any potential predictive value for PFS, as it has not yet been evaluated for ibrutinib + venetoclax treatment.METHODSUndetectable MRD (uMRD) was assessed by next-generation sequencing at <1 CLL cell per 10,000 (<10-4) and <1 CLL cell per 100,000 (<10-5) leukocytes. PFS was analyzed by MRD status at 3 months after treatment (EOT+3).RESULTSIbrutinib + venetoclax achieved deeper uMRD (<10-5) rates in bone marrow (BM) and peripheral blood (PB), respectively, in 40.6% and 43.4% of patients at EOT+3 versus 7.6% and 18.1% of patients receiving chlorambucil + obinutuzumab. Of these patients, uMRD (<10-5) in PB was sustained during the first year post-treatment (EOT+12) in 80.4% of patients receiving ibrutinib + venetoclax and 26.3% receiving chlorambucil + obinutuzumab. Patients with detectable MRD (dMRD; ≥10-4) in PB at EOT+3 were more likely to sustain MRD levels through EOT+12 with ibrutinib + venetoclax versus chlorambucil + obinutuzumab. PFS rates at EOT+12 were high among patients treated with ibrutinib + venetoclax regardless of MRD status at EOT+3: 96.3% and 93.3% in patients with uMRD (<10-4) and dMRD (≥10-4) in BM, respectively, versus 83.3% and 58.7% for patients receiving chlorambucil + obinutuzumab. PFS rates at EOT+12 also remained high in patients with unmutated immunoglobulin heavy-chain variable region (IGHV) receiving ibrutinib + venetoclax, independent of MRD status in BM.CONCLUSIONMolecular and clinical relapses were less frequent during the first year post-treatment with ibrutinib + venetoclax versus chlorambucil + obinutuzumab regardless of MRD status at EOT+3 and IGHV status. Even for patients not achieving uMRD (<10-4), PFS rate

Published
2023

27. A Phase 1 Study of ADI-001: Anti-CD20 CAR-Engineered Allogeneic Gamma Delta1 (γδ) T Cells in Adults with B-Cell Malignancies

Author

Neelapu, Sattva S., primary, Stevens, Don A., additional, Hamadani, Mehdi, additional, Frank, Matthew J., additional, Holmes, Houston, additional, Jacobovits, Aya, additional, Hinkle, John, additional, Kennedy-Wilde, Jackie, additional, Maller, Ori, additional, Weinstein, Bayarmagnai, additional, Galimi, Francesco, additional, Lai, Rose K, additional, and Miklos, David B., additional

Published
2023
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31. Safety and efficacy of tafasitamab ± lenalidomide added to first-line R‑CHOP for DLBCL: Phase 1b First-MIND study

Author

Belada, David, Kopeckova, Katerina, Bergua Burgues, Juan Miguel, Stevens, Don, André, Marc, Perez Persona, Ernesto, Pichler, Petra, Staber, Philipp B, Trněný, Marek, Duell, Johannes, Waldron-Lynch, Maeve, Wagner, Steve, Mukhopadhyay, Amitava, Dirnberger-Hertweck, Maren, Burke, John M, Nowakowski, Grzegorz S, UCL - SSS/IREC/MONT - Pôle Mont Godinne, and UCL - (MGD) Service d'hématologie

Abstract

Anti-CD19 immunotherapy tafasitamab in combination with lenalidomide is used in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) ineligible for autologous stem cell transplant. Open-label, phase 1b, First-MIND study assessed safety and preliminary efficacy of tafasitamab + R-CHOP ± lenalidomide as first-line therapy in patients with DLBCL. Adults with newly-diagnosed, untreated DLBCL (ECOG PS 0-2, IPI 2-5), were randomly assigned to R-CHOP+tafasitamab (Arm T) or R-CHOP+tafasitamab+lenalidomide (Arm T/L) for six cycles. Primary endpoint was safety; secondary endpoints included overall response rate (ORR) and complete response (CR) rate at end of treatment (EoT). From Dec2019-Aug2020, 83 patients were screened, 66 treated (n=33 per arm). All patients had ≥1 treatment-emergent adverse event, mostly grade 1/2. Grade ≥3 neutropenia and thrombocytopenia occurred in 57.6% and 12.1% of patients (Arm T), and 84.8% and 36.4% (Arm T/L). Non-hematologic toxicities occurred at similar rates between arms. Mean relative dose intensity of R-CHOP was 89% or higher in both arms. ORR at EoT was 75.8% (CR 72.7%) in Arm T and 81.8% (CR 66.7%) in Arm T/L; best ORR across visits was 90.0% and 93.9%. Eighteen-month duration of response and duration of CR rates were 72.7% and 74.5% (Arm T), and 78.7% and 86.5% (Arm T/L); 24-month progression-free survival and overall survival rates were 72.7% and 90.3% (Arm T), and 76.8% and 93.8% (Arm T/L). Manageable safety and promising signals of efficacy were observed in both arms. Potential benefit of adding tafasitamab+lenalidomide to R-CHOP is being investigated in phase 3 frontMIND (NCT04824092).

Published
2023

33. A Phase 1 Study of KT-333, a Targeted Protein Degrader of STAT3, in Patients with Relapsed or Refractory Lymphomas, Large Granular Lymphocytic Leukemia, and Solid Tumors

Author

Smith, Stephen D, primary, Starodub, Alexander, additional, Stevens, Don A., additional, Shastri, Aditi, additional, Porcu, Pierluigi, additional, Feldman, Tatyana, additional, Ewesuedo, Reggie, additional, DeSavi, Chris, additional, Dey, Joyoti, additional, Agarwal, Sagar, additional, Donohue, Sean, additional, Perea, Rachelle, additional, Klaus, Christine, additional, and Gollob, Jared, additional

Published
2022
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34. A Phase 1 Study of ADI-001: Anti-CD20 CAR-Engineered Allogeneic Gamma Delta1 (γδ) T Cells in Adults with B-Cell Malignancies

Author

Neelapu, Sattva S., primary, Stevens, Don A., additional, Hamadani, Mehdi, additional, Frank, Matthew J., additional, Holmes, Houston, additional, Jacobovits, Aya, additional, Hinkle, John, additional, Kennedy-Wilde, Jackie, additional, Maller, Ori, additional, Weinstein, Bayarmagnai, additional, Galimi, Francesco, additional, Lai, Rose K., additional, and Miklos, David B., additional

Published
2022
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35. Enitociclib (VIP152/formerly BAY1251152) Is a Selective and Active CDK9 Inhibitor : Preliminary Safety and Early Signs of Efficacy in Patients with Non-Hodgkin Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL)

Author

Shadman, Mazyar, primary, Mato, Anthony R., additional, Batlevi, Connie Lee, additional, Flinn, Ian W., additional, Gutierrez, Martin, additional, Uemura, Marc, additional, Stevens, Don A., additional, Morillo, Daniel, additional, Byrd, John C., additional, Frigault, Melanie M., additional, Clemens, George, additional, Huang, Xin, additional, Izumi, Raquel, additional, Wong, Harvey, additional, Breed, Renee, additional, Garban, Hermes, additional, Johnson, Amy J., additional, Stelte-Ludwig, Beatrix, additional, Mithal, Arushi, additional, Birkett, Joseph, additional, Hamdy, Ahmed, additional, and Rogers, Kerry A., additional

Published
2022
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36. Phase 1 Study of KT-413, a Targeted Protein Degrader of IRAK4 and IMiD Substrates, in Adult Patients with Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma

Author

Lue, Jennifer Kimberly, primary, Stevens, Don A., additional, Williams, Michael E., additional, Westin, Jason, additional, Ewesuedo, Reggie, additional, McDonald, Alice, additional, Agarwal, Sagar, additional, Henrick, Patrick, additional, Perea, Rachelle, additional, and Gollob, Jared, additional

Published
2022
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39. Postremission cytopenia management in patients with acute myeloid leukemia treated with venetoclax and azacitidine in VIALE‐A

Author

Pratz, Keith W., primary, DiNardo, Courtney D., additional, Selleslag, Dominik, additional, Li, Junmin, additional, Yamamoto, Kazuhito, additional, Konopleva, Marina, additional, Stevens, Don, additional, Kantarjian, Hagop, additional, Traina, Fabiola, additional, Venditti, Adriano, additional, Mayer, Jiri, additional, Montez, Melissa, additional, Jin, Huan, additional, Duan, Yinghui, additional, Brackman, Deanna, additional, Zha, Jiuhong, additional, Potluri, Jalaja, additional, Werner, Michael, additional, and Jonas, Brian A., additional

Published
2022
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40. CLL-106 First Prospective Data on Minimal Residual Disease Outcomes After Fixed-Duration Ibrutinib Plus Venetoclax Versus Chlorambucil Plus Obinutuzumab for First-Line Treatment of CLL in Older Adult or Unfit Patients:The GLOW Study

Author

Munir, Talha, Moreno, Carol, Owen, Carolyn, Follows, George, Benjamini, Ohad, Janssens, Ann, Levin, Mark David, Osterborg, Anders, Robak, Tadeusz, Simkovic, Martin, Stevens, Don, Voloshin, Sergey, Vorobyev, Vladimir, Yagci, Munci, Ysebaert, Loic, Qi, Qianya, Steele, Andrew, Schuier, Natasha, Baeten, Kurt, Caces, Donne Bennett, Niemann, Carsten, Kater, Arnon, Munir, Talha, Moreno, Carol, Owen, Carolyn, Follows, George, Benjamini, Ohad, Janssens, Ann, Levin, Mark David, Osterborg, Anders, Robak, Tadeusz, Simkovic, Martin, Stevens, Don, Voloshin, Sergey, Vorobyev, Vladimir, Yagci, Munci, Ysebaert, Loic, Qi, Qianya, Steele, Andrew, Schuier, Natasha, Baeten, Kurt, Caces, Donne Bennett, Niemann, Carsten, and Kater, Arnon

Abstract

Context: Minimal residual disease (MRD) is a predictive marker for progression-free survival (PFS) in chronic leukocytic leukemia (CLL) following chemoimmunotherapy and fixed-duration treatment with venetoclax and anti-CD20 antibodies. This has not been explored for ibrutinib+venetoclax (Ibr+Ven), a fixed-duration treatment with mechanisms of action that synergistically eliminate CLL subpopulations in distinct tumor compartments. Objective: Investigate MRD outcomes at primary analysis of phase 3 GLOW study (NCT03462719). Design: Randomized, open-label, active-control study. Patients: Patients aged ≥65 years or 18–64 years with a CIRS score >6 or creatinine clearance <70 mL/min were randomized 1:1, stratified by IGHV mutational and del11q status, to Ibr+Ven (n=106) or chlorambucil+obinutuzumab (Clb+O) (n=105). Excluded: patients with del17p or known TP53 mutations. Interventions: Ibr+Ven (3 cycles of ibrutinib lead-in, then 12 cycles of Ibr+Ven) or 6 cycles of Clb+O. Main Outcome Measures: Primary endpoint: independent review committee–assessed PFS; secondary endpoint: rate of undetectable MRD (uMRD; <10–4); exploratory endpoints: MRD analyses. MRD results are by next-generation sequencing, reported 3 months after end of treatment (EOT+3) unless otherwise noted. Results: Rates of uMRD<10–4 were higher for Ibr+Ven versus Clb+O in bone marrow (BM) (51.9% vs. 17.1%; P<0.0001) and peripheral blood (PB) (54.7% vs. 39.0%; P=0.0259). For Ibr+Ven, BM uMRD was higher for uIGHV (58.2%) versus mutated IGHV (44.4%). With Ibr+Ven, 84.5% (49/58) of patients maintained PB uMRD from EOT+3 to EOT+12 versus 29.3% (12/41) with Clb+O. Rates of uMRD<10–5 were higher for Ibr+Ven versus Clb+O in BM (40.6% vs. 7.6%), including patients with uIGHV (45.5% vs. 5.6%). uMRD<10–5 in PB was largely sustained from EOT+3 to EOT+12 with Ibr+Ven (80.4% [37/46]) but not Clb+O (26.3% [5/19]). PFS rates for Ibr+Ven during the 12 months a

Published
2022

45. Clinical Outcomes in Patients (Pts) with Dose Reduction of Selinexor in Combination with Bortezomib, and Dexamethasone (XVd) in Previously Treated Multiple Myeloma from the Boston Study

Author

Jagannath, Sundar, primary, Facon, Thierry, additional, Badros, Ashraf Z., additional, Levy, Moshe, additional, Moreau, Philippe, additional, Delimpasi, Sosana, additional, Simonova, Maryana, additional, Spicka, Ivan, additional, Kriachok, Iryna, additional, Gavriatopoulou, Maria, additional, Pylypenko, Halyna, additional, Auner, Holger W, additional, Leleu, Xavier, additional, Doronin, Vadim, additional, Usenko, Ganna, additional, Hajek, Roman, additional, Benjamin, Reuben, additional, Dolai, Tuphan Kanti, additional, Sinha, Dinesh Kumar, additional, Venner, Chris P., additional, Garg, Mamta, additional, Gironella Mesa, Mercedes, additional, Jurczyszyn, Artur, additional, Robak, Tadeusz, additional, Galli, Monica, additional, Wallington-Beddoe, Craig Thomas, additional, Radinoff, Atanas, additional, Salogub, Galina, additional, Stevens, Don, additional, Basu, Supratik, additional, Liberati, Anna Marina, additional, Quach, Hang, additional, Goranova Marinova, Veselina S, additional, Bila, Jelena Sreten, additional, Katodritou, Eirini, additional, DeCastro, Andrew, additional, Chai, Yi, additional, Van Domelen, Dane R., additional, Mishal, Moran, additional, Bentur, Ohad S., additional, Shah, Jatin, additional, Shacham, Sharon, additional, Kauffman, Michael G., additional, Grosicki, Sebastian, additional, and Richardson, Paul G., additional

Published
2021
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46. Safety and Efficacy of Tenalisib Given in Combination with Romidepsin in Patients with Relapsed/Refractory T-Cell Lymphoma: Final Results from a Phase I/II Open Label Multi-Center Study

Author

Iyer, Swaminathan P, primary, Huen, Auris, additional, Ai, Weiyun Z., additional, Jagadeesh, Deepa, additional, Lechowicz, Mary Jo, additional, Okada, Craig, additional, Feldman, Tatyana A., additional, Sundaram, Suchitra, additional, Alderuccio, Juan Pablo, additional, Reddy, Nishitha, additional, Stevens, Don, additional, Kuzel, Timothy M., additional, Mohrbacher, Ann, additional, Routhu, Kasi Viswanath, additional, Barde, Prajak, additional, Nair, Ajit Mohanchandran, additional, and Haverkos, Brad M., additional

Published
2021
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47. A Phase 2/3, Multicenter Randomized Study of Rituximab-Gemcitabine-Dexamethasone-Platinum (R-GDP) with or without Selinexor in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (RR DLBCL)

Author

Lee, Seung Tae, primary, Pinto, Antonio, additional, Yimer, Habte, additional, Stevens, Don, additional, Knopinska Posluszny, Wanda, additional, Shum, Merrill Kingman, additional, Manda, Sudhir, additional, Leiba, Merav, additional, Canales, Miguel, additional, Kaźmierczak, Maciej, additional, Jurczak, Wojciech, additional, Sureda, Anna, additional, Ma, Xiwen, additional, Li, Kai, additional, Ingalls, Kimberly, additional, Arriola, Tara, additional, Arazy, Melina, additional, Shah, Jatin J., additional, Shacham, Sharon, additional, Kauffman, Michael G., additional, and Nowakowski, Grzegorz S., additional

Published
2021
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48. First-Mind: Primary Analysis from a Phase Ib, Open-Label, Randomized Study to Assess Safety of Tafasitamab or Tafasitamab + Lenalidomide in Addition to R-CHOP in Patients with Newly Diagnosed Diffuse Large B-Cell Lymphoma

Author

Belada, David, primary, Kopeckova, Katerina, additional, Bergua Burgues, Juan Miguel, additional, Stevens, Don, additional, André, Marc, additional, Pérez Persona, Ernesto, additional, Pichler, Petra, additional, Staber, Philipp B., additional, Trneny, Marek, additional, Brackertz, Bettina, additional, Shah, Neha, additional, Sporchia, Andrea, additional, Burke, John M., additional, and Nowakowski, Grzegorz S., additional

Published
2021
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49. Safety and Efficacy of Cusatuzumab in Combination with Venetoclax and Azacitidine (CVA) in Patients with Previously Untreated Acute Myeloid Leukemia (AML) Who Are Not Eligible for Intensive Chemotherapy; An Open-Label, Multicenter, Phase 1b Study

Author

Roboz, Gail J., primary, Pabst, Thomas, additional, Aribi, Ahmed, additional, Brandwein, Joseph M., additional, Döhner, Hartmut, additional, Fiedler, Walter, additional, Gandini, Domenica, additional, Geddes, Michelle, additional, Hou, Jing-Zhou, additional, Howes, Angela J., additional, Hultberg, Anna, additional, Huselton, Eric, additional, Jacobs, Julie, additional, Kane, Colleen, additional, Lech-Marańda, Ewa, additional, Louwers, Marieke, additional, Nottage, Kerri, additional, Platzbecker, Uwe, additional, Rampal, Raajit, additional, Salman, Mariya, additional, Shah, Priya, additional, Stevens, Don, additional, Stuart, Monic, additional, Subklewe, Marion, additional, Sumbul, Anne, additional, Wang, Eunice S., additional, Wierzbowska, Agnieszka, additional, Yao, Bin, additional, Yee, Karen, additional, Kantarjian, Hagop, additional, and Borthakur, Gautam, additional

Published
2021
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50. ALPHA Study: ALLO-501 Produced Deep and Durable Responses in Patients with Relapsed/Refractory Non-Hodgkin's Lymphoma Comparable to Autologous CAR T

Author

Neelapu, Sattva S., primary, Nath, Rajneesh, additional, Munoz, Javier, additional, Tees, Michael, additional, Miklos, David B., additional, Frank, Matthew J., additional, Malik, Shahbaz A., additional, Stevens, Don, additional, Shin, Chu Ri, additional, Balakumaran, Arun, additional, Loomis-Navale, Lynn, additional, Goyal, Lovely, additional, Nguyen, Anh, additional, and Locke, Frederick L., additional

Published
2021
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