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3. Past-directed scalar field gradients and scalar-tensor thermodynamics

Author

Giusti, A., Giardino, S., and Faraoni, V.

Subjects
Modified gravity, Scalar-tensor gravity, Thermodynamics, Scalar field, Physics and Astronomy (miscellaneous), FOS: Physical sciences, General Relativity and Quantum Cosmology (gr-qc), General Relativity and Quantum Cosmology
Abstract

We refine and slightly enlarge the recently proposed first-order thermodynamics of scalar-tensor gravity to include gravitational scalar fields with timelike and past-directed gradients. The implications and subtleties arising in this situation are discussed and an exact cosmological solution of scalar-tensor theory in first-order thermodynamics is revisited in light of these results., General Relativity and Gravitation, 55 (3), ISSN:0001-7701, ISSN:1572-9532

Published
2023

11. Outcome of patients with Fanconi anemia developing myelodysplasia and acute leukemia who received allogeneic hematopoietic stem cell transplantation: A retrospective analysis on behalf of EBMT group

Author

Giardino, S., de Latour, R. P., Aljurf, M., Eikema, D. -J., Bosman, P., Bertrand, Y., Tbakhi, A., Holter, W., Bornhauser, M., Rossig, C., Burkhardt, B., Zecca, M., Afanasyev, B., Michel, G., Ganser, A., Alseraihy, A., Ayas, M., Uckan-Cetinkaya, D., Bruno, B., Patrick, K., Bader, P., Itala-Remes, M., Rocha, V., Jubert, C., Diaz, M. A., Shaw, P. J., Junior, L. G. D., Locatelli, Franco, Kroger, N., Faraci, M., Pierri, F., Lanino, E., Miano, M., Risitano, A., Robin, M., Dufour, C., Locatelli F. (ORCID:0000-0002-7976-3654), Giardino, S., de Latour, R. P., Aljurf, M., Eikema, D. -J., Bosman, P., Bertrand, Y., Tbakhi, A., Holter, W., Bornhauser, M., Rossig, C., Burkhardt, B., Zecca, M., Afanasyev, B., Michel, G., Ganser, A., Alseraihy, A., Ayas, M., Uckan-Cetinkaya, D., Bruno, B., Patrick, K., Bader, P., Itala-Remes, M., Rocha, V., Jubert, C., Diaz, M. A., Shaw, P. J., Junior, L. G. D., Locatelli, Franco, Kroger, N., Faraci, M., Pierri, F., Lanino, E., Miano, M., Risitano, A., Robin, M., Dufour, C., and Locatelli F. (ORCID:0000-0002-7976-3654)

Abstract

Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is curative for bone marrow failure in patients with Fanconi anemia (FA), but the presence of a malignant transformation is associated with a poor prognosis and the management of these patients is still challenging. We analyzed outcome of 74 FA patients with a diagnosis of myelodysplastic syndrome (n = 35), acute leukemia (n = 35) or with cytogenetic abnormalities (n = 4), who underwent allo-HSCT from 1999 to 2016 in EBMT network. Type of diagnosis, pre-HSCT cytoreductive therapies and related toxicities, disease status pre-HSCT, donor type, and conditioning regimen were considered as main variables potentially influencing outcome. The 5-year OS and EFS were 42% (30-53%) and 39% (27-51%), respectively. Patients transplanted in CR showed better OS compared with those transplanted in presence of an active malignant disease (OS:71%[48-95] vs 37% [24-50],P =.04), while none of the other variables considered had an impact. Twenty-two patients received pre-HSCT cytoreduction and 9/22 showed a grade 3-4 toxicity, without any lethal event or negative influence on survival after HSCT(OS:toxicity pre-HSCT 48% [20-75%] vs no-toxicity 51% [25-78%],P =.98). The cumulative incidence of day-100 grade II-IV a-GvHD and of 5-year c-GvHD were 38% (26-50%) and 40% (28-52%). Non-relapse-related mortality and incidence of relapse at 5-years were 40% (29-52%) and 21% (11-30%) respectively, without any significant impact of the tested variables. Causes of death were transplant-related events in most patients (34 out of the 42 deaths, 81%). This analysis confirms the poor outcome of transformed FA patients and identifies the importance of achieving CR pre-HSCT, suggesting that, in a newly diagnosed transformed FA patient, a cytoreductive approach pre-HSCT should be considered if a donor have been secured.

Published
2020

15. Gonadal Function after Busulfan Compared with Treosulfan in Children and Adolescents Undergoing Allogeneic Hematopoietic Stem Cell Transplant

Author

Faraci, M., Diesch, T., Labopin, M., Dalissier, A., Lankester, A., Gennery, A., Sundin, M., Uckan-Cetinkaya, D., Bierings, M., Peters, A.M.J., Garwer, M., Schulz, A., Michel, G., Giorgiani, G., Gruhn, B., Locatelli, F., Giardino, S., Uyttebroeck, A., Rialland, F., Itala-Remes, M., Dreger, P., Shaw, P.J., Bordon, V., Schlegel, P.G., Mellgren, K., Moraleda, J.M., Patrick, K., Schneider, P., Jubert, C., Lawitschka, A., Salooja, N., Basak, G.W., Corbacioglu, S., Duarte, R., Bader, P., and Pediat Transplant Complications Wo

Subjects
Treo, Adult, Male, Pediatrics, medicine.medical_specialty, Cyclophosphamide, Adolescent, Puberty, Precocious, Treosulfan, medicine, Humans, pubertal stage, Child, Gonads, Busulfan, Retrospective Studies, Transplantation, business.industry, Late effect, Hematopoietic Stem Cell Transplantation, gonadal damage, Hematology, Allografts, Settore MED/38 - PEDIATRIA GENERALE E SPECIALISTICA, Prepubertal stage, Child, Preschool, Female, busulfan, treosulfan, Transplantation Conditioning, medicine.symptom, business, Chemoradiotherapy, medicine.drug
Abstract

Gonadal impairment is an important late effect with a significant impact on quality of life of transplanted patients. The aim of this study was to compare gonadal function after busulfan (Bu) or treosulfan (Treo) conditioning regimens in pre- and postpubertal children. This retrospective, multicenter study included children transplanted in pediatric European Society for Blood and Marrow Transplantation (EBMT) centers between 1992 and 2012 who did not receive gonadotoxic chemoradiotherapy before the transplant. We evaluated 137 patients transplanted in 25 pediatric EBMT centers. Median age at transplant was 11.04 years (range, 5 to 18); 89 patients were boys and 48 girls. Eighty-nine patients were prepubertal at transplant and 48 postpubertal. One hundred eighteen children received Bu and 19 Treo. A higher proportion of girls treated with Treo in the prepubertal stage reached spontaneous puberty compared with those treated with Bu (P = .02). Spontaneous menarche was more frequent after Treo than after Bu (P < .001). Postpubertal boys and girls treated with Treo had significantly lower luteinizing hormone levels (P = .03 and P = .04, respectively) compared with the Bu group. Frequency of gonadal damage associated with Treo was significantly lower than that observed after Bu. These results need to be confirmed in a larger population.

Published
2019

16. Two pregnancies shortly after transplantation with reduced intensity conditioning in chronic myeloid leukemia

Author

Faraci, M, Matthes-Martin, S, Lanino, E, Morreale, G, Ferretti, M, Giardino, S, Micalizzi, C, Balduzzi, A, Faraci M, Matthes-Martin S, Lanino E, Morreale G, Ferretti M, Giardino S, Micalizzi C, Balduzzi A, Faraci, M, Matthes-Martin, S, Lanino, E, Morreale, G, Ferretti, M, Giardino, S, Micalizzi, C, Balduzzi, A, Faraci M, Matthes-Martin S, Lanino E, Morreale G, Ferretti M, Giardino S, Micalizzi C, and Balduzzi A

Abstract

POI is a relevant late complication after HSCT and occurring more frequently after MAC than after RIC regimens. Reports on the frequency of POI after RIC in a large pediatric and adolescent population are lacking. In this study, we describe a girl affected by CML diagnosed at the age of 15 yr and treated with oncarbide and interferon followed by imatinib and dasatinib. She had two pregnancies shortly after RIC performed according to the CML-SCT I-BFM protocol including TT, FLU, and MEL. Hypergonadotropic hypogonadism occurred four months after HSCT; menstruations resumed regularly six months after HSCT. Eight and 20 months after HSCT, the patient became pregnant and then delivered, respectively, two babies at term by cesarean section. Both newborns had no neonatal complications. Donor chimerism at time of two pregnancies and five yr after transplantation demonstrated complete donor engraftment. These findings suggest that I-BFM CML-SCT protocol could be a promising treatment option for adolescents or young adults with CML eligible for HSCT.

Published
2016

17. Outcomes of Children with Hemophagocytic Lymphohistiocytosis Given Allogeneic Hematopoietic Stem Cell Transplantation in Italy

Author

Messina, C., Zecca, M., Fagioli, F., Rovelli, A., Giardino, S., Merli, P., Porta, F., Arico, M., Sieni, E., Basso, G., Ripaldi, M., Favre, C., Pillon, M., Marzollo, A., Rabusin, M., Cesaro, S., Algeri, M., Caniglia, M., Di Bartolomeo, P., Ziino, O., Saglio, F., Prete, A., Locatelli, Franco, Locatelli F. (ORCID:0000-0002-7976-3654), Messina, C., Zecca, M., Fagioli, F., Rovelli, A., Giardino, S., Merli, P., Porta, F., Arico, M., Sieni, E., Basso, G., Ripaldi, M., Favre, C., Pillon, M., Marzollo, A., Rabusin, M., Cesaro, S., Algeri, M., Caniglia, M., Di Bartolomeo, P., Ziino, O., Saglio, F., Prete, A., Locatelli, Franco, and Locatelli F. (ORCID:0000-0002-7976-3654)

Abstract

We report on 109 patients with hemophagocytic lymphohistiocytosis (HLH) undergoing 126 procedures of allogeneic hematopoietic stem cell transplantation (HSCT) between 2000 and 2014 in centers associated with the Italian Pediatric Hematology Oncology Association. Genetic diagnosis was FHL2 (32%), FHL3 (33%), or other defined disorders known to cause HLH (15%); in the remaining patients no genetic abnormality was found. Donor for first transplant was an HLA-matched sibling for 25 patients (23%), an unrelated donor for 73 (67%), and an HLA-partially matched family donor for 11 children (10%). Conditioning regimen was busulfan-based for 61 patients (56%), treosulfan-based for 21 (20%), and fludarabine-based for 26 children (24%). The 5-year probabilities of overall survival (OS) and event-free survival (EFS) were 71% and 60%, respectively. Twenty-six patients (24%) died due to transplant-related causes, whereas 14 (13%) and 10 (9%) patients experienced graft rejection and/or relapse, respectively. Twelve of 14 children given a second HSCT after graft failure/relapse are alive and disease-free. Use of HLA-partially matched family donors was associated with higher risk of graft failure and thus with lower EFS (but not with lower OS) in multivariable analysis. Active disease at transplantation did not significantly affect prognosis. These data confirm that HSCT can cure most HLH patients, active disease not precluding successful transplantation. Because in HLH patients HLA-haploidentical HSCT performed through CD34 + cell positive selection was found to be associated with poor sustained engraftment of donor cells, innovative approaches able to guarantee a more robust engraftment are warranted in patients given this type of allograft.

Published
2018

18. Unrelated Cord Blood Transplantation for Acute Leukemia Diagnosed in the First Year of Life: Outcomes and Risk Factor Analysis

Author

Ruggeri, A., Volt, F., Locatelli, Franco, Michel, G., Diaz de Heredia, C., Abecasis, M., Zecca, M., Vora, A., Yakouben, K., O'Brien, T. A., Giardino, S., Cornish, J., Rocha, V., Peters, C., Bader, P., Gluckman, E., Dalle, J. H., Locatelli F. (ORCID:0000-0002-7976-3654), Ruggeri, A., Volt, F., Locatelli, Franco, Michel, G., Diaz de Heredia, C., Abecasis, M., Zecca, M., Vora, A., Yakouben, K., O'Brien, T. A., Giardino, S., Cornish, J., Rocha, V., Peters, C., Bader, P., Gluckman, E., Dalle, J. H., and Locatelli F. (ORCID:0000-0002-7976-3654)

Abstract

Infant acute leukemia still has a poor prognosis, and allogeneic hematopoietic stem cell transplantation is indicated in selected patients. Umbilical cord blood (UCB) is an attractive cell source for this population because of the low risk of chronic graft-versus-host disease (GVHD), the strong graft-versus-leukemia effect, and prompt donor availability. This retrospective, registry-based study reported UCB transplantation (UCBT) outcomes in 252 children with acute lymphoblastic leukemia (ALL; n = 157) or acute myelogenous leukemia (AML; n = 95) diagnosed before 1 year of age who received a single-unit UCBT after myeloablative conditioning between 1996 and 2012 in European Society for Blood and Marrow Transplantation centers. Median age at UCBT was 1.1 years, and median follow-up was 42 months. Most patients (57%) received a graft with 1 HLA disparity and were transplanted in first complete remission (CR; 55%). Cumulative incidence function (CIF) of day 100 acute GVHD (grades II to IV) was 40% ± 3% and of 4-year chronic GVHD was 13% ± 2%. CIF of 1-year transplant-related mortality was 23% ± 3% and of 4-year relapse was 27% ± 3%. Leukemia-free-survival (LFS) at 4 years was 50% ± 3%; it was 40% and 66% for those transplanted for ALL and AML, respectively (P = .001). LFS was better for patients transplanted in first CR, regardless of diagnosis. In multivariate model, diagnosis of ALL (P = .001), advanced disease status at UCBT (<.001), age at diagnosis younger than 3 months (P = .012), and date of transplant before 2004 were independently associated with worse LFS. UCBT is a suitable option for patients diagnosed with infant acute leukemia who achieve CR. In this cohort, patients with AML had better survival than those with ALL.

Published
2017

19. Nuovi dati sui flysch del Cilento (Appennino Meridionale, Italia)

Author

CAMMAROSANO A., CAVUOTO G., DANNA M., DE RIENZO F., DI STASO A., GIARDINO S., MARTELLI L., SGROSSO A., TOCCACELI R. M. VALENTE A. ., DE CAPOA, PAOLA, NARDI, GIUSEPPE, Cammarosano, A., Cavuoto, G., Danna, M., DE CAPOA, Paola, DE RIENZO, F., DI STASO, A., Giardino, S., Martelli, L., Nardi, Giuseppe, Sgrosso, A., and Toccaceli, R. M. VALENTE A. .

Published
2004

21. Nuovi dati sui flysch del Cilento (Appennino meridionale, Italia)

Author

CAMMAROSANO, ANTONELLA, CAVUOTO, GIUSEPPE, DANNA, MASSIMO, DE CAPOA, PAOLA, DI STASO, ANGELIDA, NARDI, GIUSEPPE, SGROSSO, ANDREA, DE RIENZO F., GIARDINO S., MARTELLI L., TOCCACELI R. M., VALENTE A., Cammarosano, Antonella, Cavuoto, Giuseppe, Danna, Massimo, DE CAPOA, Paola, DE RIENZO, F., DI STASO, Angelida, Giardino, S., Martelli, L., Nardi, Giuseppe, Sgrosso, Andrea, Toccaceli, R. M., and Valente, A.

Subjects
Flysch del Cilento, stratigrafia, biostratigrafia
Published
2004

44. The role of pharmacies in haematopoietic stem cell transplantation process: A nationwide survey by Gruppo Italiano Trapianto di Midollo Osseo

Author

Fabio Ciceri, Valentina Iurilli, Sonia Mammoliti, Stefano Giardino, Chiara Cannici, Nicola Serra, Maura Faraci, Stefano Botti, Ines Lorenzi, Massimo Martino, Faraci, M., Lorenzi, I., Martino, M., Mammoliti, S., Iurilli, V., Serra, N., Giardino, S., Cannici, C., Ciceri, F., and Botti, S.

Subjects
pharmacy, medicine.medical_specialty, Attitude of Health Personnel, haematopoietic stem cell transplantation, pharmacist, education, Pharmacist, Pharmacy, Computer-assisted web interviewing, Hospitals, Special, GITMO, Autologous stem-cell transplantation, Adverse Drug Reaction Reporting Systems, Humans, Medicine, Pharmacology (medical), Cooperative Behavior, Adverse effect, Pharmacology, Univariate analysis, business.industry, Hematopoietic Stem Cell Transplantation, Transplantation, side effects, surgical procedures, operative, Parenteral nutrition, Italy, Pharmaceutical Services, Family medicine, business
Abstract

What is known and objective The aim of this survey, conducted by the Gruppo Italiano per il Trapianto di Midollo Osseo (GITMO), was to evaluate the involvement of pharmacists in the haematopoietic stem cell transplant (HSCT) program in Italian adult and paediatric centres. Methods A 63-item online questionnaire was developed and sent to the Italian Transplant Programs on behalf of GITMO. Results and discussion Overall, 54.7% of the Italian HSCT centres participated in the survey (88.5% adult, 7.7% paediatric, 3.8% mixed), of which 50% were in public hospitals and 50% affiliated with public universities. Just over 80% declared that a pharmacist is involved in the HSCT centre, and 86.5% reported the presence of a documentation system to signal of adverse events, accessible by physicians, nurses and pharmacists in 57.7%. Chemotherapy drugs were centralized in the pharmacy in 98.1% of HSCT centres, while parenteral nutrition was centralized in 55.8%. The use of off-label drugs was authorized by an internal committee and by the regional health authorities in 88.5% of the centres. On univariate analysis, few statistically significant differences were found on response frequencies between public hospitals and university centres or between HSCT centres performing only autologous stem cell transplantation versus other centres performing autologous and allogeneic stem cell transplantation. What is new and conclusion This survey suggests that there is good collaboration between pharmacists and physicians and nurses in Italian HSCT transplantation centres. The enhancement of pharmacists dedicated to HSCT programs could improve some problems, for example, the centralization of parenteral nutrition.

Published
2021

45. Outcome of patients with Fanconi anemia developing myelodysplasia and acute leukemia who received allogeneic hematopoietic stem cell transplantation: A retrospective analysis on behalf of EBMT group

Author

Charlotte Jubert, Wolfgang Holter, Mahmoud Aljurf, Bénédicte Bruno, Claudia Rossig, Miguel Angel Diaz, Maura Faraci, Duygu Uckan-Cetinkaya, Birgit Burkhardt, Marco Zecca, Marie Robin, Peter Bader, Paul Bosman, Antonio M. Risitano, Katharine Patrick, Dirk-Jan Eikema, Edoardo Lanino, Luiz Guilherme Darrigo Junior, Gérard Michel, Vanderson Rocha, Franco Locatelli, Arnold Ganser, Carlo Dufour, Filomena Pierri, Maurizio Miano, Nicolaus Kröger, Abdelghani Tbakhi, Stefano Giardino, Amal Al-Seraihy, Maija Itälä-Remes, Mouhab Ayas, Boris V. Afanasyev, Yves Bertrand, Peter J. Shaw, Régis Peffault de Latour, Martin Bornhäuser, Giardino, S., de Latour, R. P., Aljurf, M., Eikema, D. -J., Bosman, P., Bertrand, Y., Tbakhi, A., Holter, W., Bornhauser, M., Rossig, C., Burkhardt, B., Zecca, M., Afanasyev, B., Michel, G., Ganser, A., Alseraihy, A., Ayas, M., Uckan-Cetinkaya, D., Bruno, B., Patrick, K., Bader, P., Itala-Remes, M., Rocha, V., Jubert, C., Diaz, M. A., Shaw, P. J., Junior, L. G. D., Locatelli, F., Kroger, N., Faraci, M., Pierri, F., Lanino, E., Miano, M., Risitano, A., Robin, M., and Dufour, C.

Subjects
Male, medicine.medical_specialty, medicine.medical_treatment, Hematopoietic stem cell transplantation, Gastroenterology, Disease-Free Survival, 03 medical and health sciences, 0302 clinical medicine, Fanconi anemia, Internal medicine, medicine, Humans, Cumulative incidence, Survival rate, Retrospective Studies, Acute leukemia, Leukemia, business.industry, Myelodysplastic syndromes, Bone marrow failure, Hematopoietic Stem Cell Transplantation, Hematology, medicine.disease, Allografts, Survival Rate, surgical procedures, operative, Fanconi Anemia, Settore MED/38 - PEDIATRIA GENERALE E SPECIALISTICA, leukemia, stem cell transplantation, 030220 oncology & carcinogenesis, Myelodysplastic Syndromes, Acute Disease, Female, business, 030215 immunology, Follow-Up Studies
Abstract

Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is curative for bone marrow failure in patients with Fanconi anemia (FA), but the presence of a malignant transformation is associated with a poor prognosis and the management of these patients is still challenging. We analyzed outcome of 74 FA patients with a diagnosis of myelodysplastic syndrome (n = 35), acute leukemia (n = 35) or with cytogenetic abnormalities (n = 4), who underwent allo-HSCT from 1999 to 2016 in EBMT network. Type of diagnosis, pre-HSCT cytoreductive therapies and related toxicities, disease status pre-HSCT, donor type, and conditioning regimen were considered as main variables potentially influencing outcome. The 5-year OS and EFS were 42% (30-53%) and 39% (27-51%), respectively. Patients transplanted in CR showed better OS compared with those transplanted in presence of an active malignant disease (OS:71%[48-95] vs 37% [24-50],P = .04), while none of the other variables considered had an impact. Twenty-two patients received pre-HSCT cytoreduction and 9/22 showed a grade 3-4 toxicity, without any lethal event or negative influence on survival after HSCT(OS:toxicity pre-HSCT 48% [20-75%] vs no-toxicity 51% [25-78%],P = .98). The cumulative incidence of day-100 grade II-IV a-GvHD and of 5-year c-GvHD were 38% (26-50%) and 40% (28-52%). Non-relapse-related mortality and incidence of relapse at 5-years were 40% (29-52%) and 21% (11-30%) respectively, without any significant impact of the tested variables. Causes of death were transplant-related events in most patients (34 out of the 42 deaths, 81%). This analysis confirms the poor outcome of transformed FA patients and identifies the importance of achieving CR pre-HSCT, suggesting that, in a newly diagnosed transformed FA patient, a cytoreductive approach pre-HSCT should be considered if a donor have been secured.

Published
2020

46. Two pregnancies shortly after transplantation with reduced intensity conditioning in chronic myeloid leukemia

Author

Adriana Balduzzi, Stefano Giardino, Concetta Micalizzi, Edoardo Lanino, Susanne Matthes-Martin, Giuseppe Morreale, Marta Ferretti, Maura Faraci, Faraci, M, Matthes-Martin, S, Lanino, E, Morreale, G, Ferretti, M, Giardino, S, Micalizzi, C, and Balduzzi, A

Subjects
Pediatrics, medicine.medical_specialty, Transplantation Conditioning, premature ovarian insufficiency, Adolescent, medicine.medical_treatment, Dasatinib, Antineoplastic Agents, Hematopoietic stem cell transplantation, hematopoietic stem cell transplantation, chronic myeloid leukemia, pregnancy, fertility, childhood, Primary Ovarian Insufficiency, Premature ovarian insufficiency, Disease-Free Survival, Drug Administration Schedule, Menstruations, Young Adult, 03 medical and health sciences, 0302 clinical medicine, Hypergonadotropic hypogonadism, Pregnancy, immune system diseases, chronic myeloid leukemia, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, hemic and lymphatic diseases, medicine, Humans, Hydroxyurea, Young adult, Transplantation, business.industry, Hematopoietic Stem Cell Transplantation, medicine.disease, Treatment Outcome, surgical procedures, operative, reduced intensity conditioning regimen, 030220 oncology & carcinogenesis, Pediatrics, Perinatology and Child Health, Imatinib Mesylate, Female, Interferons, business, 030215 immunology, medicine.drug
Abstract

POI is a relevant late complication after HSCT and occurring more frequently after MAC than after RIC regimens. Reports on the frequency of POI after RIC in a large pediatric and adolescent population are lacking. In this study, we describe a girl affected by CML diagnosed at the age of 15 yr and treated with oncarbide and interferon followed by imatinib and dasatinib. She had two pregnancies shortly after RIC performed according to the CML-SCT I-BFM protocol including TT, FLU, and MEL. Hypergonadotropic hypogonadism occurred four months after HSCT; menstruations resumed regularly six months after HSCT. Eight and 20 months after HSCT, the patient became pregnant and then delivered, respectively, two babies at term by cesarean section. Both newborns had no neonatal complications. Donor chimerism at time of two pregnancies and five yr after transplantation demonstrated complete donor engraftment. These findings suggest that I-BFM CML-SCT protocol could be a promising treatment option for adolescents or young adults with CML eligible for HSCT.

Published
2016

47. Monitoring and Management of Cytomegalovirus Reactivations After Allogeneic Hematopoietic Stem Cell Transplantation in Children: Experience from a Single Pediatric Center.

Author

Ferrando G, Bagnasco F, Giardino S, Pierri F, Pestarino S, Di Marco E, Santaniello M, Castagnola E, and Faraci M

Abstract

Background: CMV reactivation represents a frequent complication after HSCT. The aim of this study was to describe the incidence of CMV reactivation in a pediatric HSCT cohort and analyze the potential impact of recipient/donor-related or transplant-related factors on this complication. Furthermore, we analyzed the management of CMV reactivation in order to purpose criteria for pre-emptive therapy., Methods: Allogeneic HSCTs, performed at IRCCS Istituto Gaslini between 2012 and 2022, were included in this analysis. CMV-DNAemia was regularly monitored. Risk stratification was based on donor/recipient serological status and additional potential risk factors were considered: haploidentical transplant; any HSCT subsequent to the first; acute and chronic GvHD; steroids; and other immunosuppressive therapies. We described also the approach for pre-emptive therapy during the period 2012-2019., Results: A total of 214 allogeneic HSCTs were performed in 189 patients. In total, 100 (46.7%) HSCTs were complicated by at least one reactivation. CMV reactivation was significantly associated with high serological risk and steroid treatment. Pre-emptive therapy was administered in 59/69 (85.5%) HSCTs during 2012-2019. In the presence of predefined risk conditions, therapy was started at a median viremia of 2050 copies/mL. No difference was observed in OS between patients with CMV reactivation versus patients who did not present this complication., Conclusions: These results suggest the potential effectiveness of the approach used in providing pre-emptive therapy based on viral load monitoring and individualized risk factors.

Published
2024
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48. Epstein-Barr virus reactivation in pediatric allogeneic stem cell transplant recipients: an 11-year experience on viral load and B lymphocyte monitoring strategy.

Author

Ferrando G, Bagnasco F, Pierri F, Pestarino S, Dell'Orso G, Giardino S, Di Marco E, Santaniello M, Castagnola E, and Faraci M

Subjects
Humans, Child, Female, Male, Child, Preschool, Adolescent, Retrospective Studies, Infant, Young Adult, Lymphoproliferative Disorders etiology, Rituximab therapeutic use, Rituximab adverse effects, Viral Load, Herpesvirus 4, Human immunology, Herpesvirus 4, Human physiology, Epstein-Barr Virus Infections immunology, Epstein-Barr Virus Infections virology, Virus Activation, Hematopoietic Stem Cell Transplantation adverse effects, Transplantation, Homologous adverse effects, B-Lymphocytes immunology
Abstract

Background: Epstein-Barr virus (EBV) reactivation represents a frequent condition after allogeneic hematopoietic stem cell transplantation (allo-HCT) and can cause the development of a severe complication: post-transplant lymphoproliferative disease (PTLD). This retrospective study aims at investigating the incidence of EBV reactivations and analyzing the potential impact of recipient/donor-related transplant-related factors in pediatric patients. The secondary objective was to study the consequences of the approach used at our center regarding the initiation of pre-emptive therapy., Methods: This study used a retrospective evaluation of patients aged ≤25 years who received an allo-HCT at IRCCS (Istituto di Ricovero e Cura a Carattere Scientifico) Istituto Giannina Gaslini, between 2012 and 2022, with follow-up censored in July 2023. Criteria to start rituximab were as follows: a viral load ≥20,000 copies/10 5 PBMCs or ≥10,000/10 5 PBMCs associated with a rise in the proportion of CD 20+ lymphocytes., Results: Overall, 214 allo-HCTs were performed in 189 patients. A total of 127 (59.3%) procedures were complicated by at least one EBV reactivation, but in only one rituximab was administered. All other reactivations were characterized by viremia below reference ranges and no increase in CD20+ lymphocytes, without clinical consequences. Risk factors for EBV reactivation identified were associated with delayed immune reconstitution., Conclusion: These results could suggest the effectiveness of the approach used in providing pre-emptive therapy. The strategy adopted differs from that highlighted by other studies and allowed the reduction of the number of children who received rituximab. It has proven effective considering the low incidence rate of PTLD and reduces the risk of rituximab-related adverse events., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Ferrando, Bagnasco, Pierri, Pestarino, Dell’Orso, Giardino, Di Marco, Santaniello, Castagnola and Faraci.)

Published
2024
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49. Interleukin-1 blockade in patients with Wiskott-Aldrich syndrome: a retrospective multinational case series.

Author

Naviglio S, Cicalese MP, Rivers E, Ferrua F, Bonfim C, Cenciarelli S, Cheong KN, Faraci M, Giardino S, Ghosh S, Lee PP, Lyra PT, Meisel R, Sofia V, Tessitore A, Tommasini A, Valencic E, Vallée TC, Volpi S, Worth AJ, Rabusin M, Albert MH, Thrasher AJ, and Aiuti A

Subjects
Humans, Retrospective Studies, Male, Female, Infant, Child, Preschool, Hematopoietic Stem Cell Transplantation, Child, Adolescent, Antibodies, Monoclonal therapeutic use, Antibodies, Monoclonal adverse effects, Interleukin 1 Receptor Antagonist Protein therapeutic use, Wiskott-Aldrich Syndrome therapy, Antibodies, Monoclonal, Humanized therapeutic use, Interleukin-1 antagonists & inhibitors
Abstract

Abstract: Up to 70% of patients with Wiskott-Aldrich syndrome (WAS) develop autoimmune and inflammatory manifestations. Dysregulation of interleukin 1 (IL-1) may be involved in their pathogenesis, yet there is little evidence on treatment with anti-IL-1 agents in these patients. We conducted a multicenter retrospective analysis of 9 patients with WAS treated with anti-IL-1 agents (anakinra or canakinumab). All patients had prominent inflammatory manifestations, including systemic, cutaneous, articular, and intestinal symptoms; 3 patients presented with a severe systemic inflammatory syndrome since the first months of life. Corticosteroid therapy was associated with partial or no response, whereas treatment with anakinra or canakinumab resulted in prompt, often dramatic, responses in all patients, allowing bridging to gene therapy (4 patients) or hematopoietic stem cell transplantation (HSCT; 5 patients). Treatment was overall well tolerated. Low donor myeloid chimerism developed in 4 patients after HSCT and was associated with the appearance or the recurrence of inflammatory manifestations. A second HSCT was performed in 2 patients, achieving full-donor chimerism and resolution of inflammatory manifestation, whereas the other 2 patients were treated with prolonged therapy with anti-IL-1 agents. Our experience demonstrates that some inflammatory manifestations of WAS are dependent on IL-1 and respond well to its pharmacologic blockade., (© 2024 American Society of Hematology. Published by Elsevier Inc. All rights are reserved, including those for text and data mining, AI training, and similar technologies.)

Published
2024
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50. Outcomes of HLA-mismatched HSCT with TCRαβ/CD19 depletion or post-HSCT cyclophosphamide for inborn errors of immunity.

Author

Lum SH, Albert MH, Gilbert P, Sirait T, Algeri M, Muratori R, Fournier B, Laberko A, Karakukcu M, Unal E, Ayas M, Yadav SP, Fisgin T, Elfeky R, Fernandes J, Faraci M, Cole T, Schulz A, Meisel R, Zecca M, Ifversen M, Biffi A, Diana JS, Vallée T, Giardino S, Ersoy GZ, Moshous D, Gennery AR, Balashov D, Bonfim C, Locatelli F, Lankester A, Neven B, and Slatter M

Subjects
Humans, Child, Child, Preschool, Female, Male, Infant, Adolescent, Retrospective Studies, Young Adult, Lymphocyte Depletion, Transplantation Conditioning methods, HLA Antigens immunology, Adult, Treatment Outcome, Infant, Newborn, Hematopoietic Stem Cell Transplantation adverse effects, Hematopoietic Stem Cell Transplantation methods, Cyclophosphamide therapeutic use, Cyclophosphamide administration & dosage, Receptors, Antigen, T-Cell, alpha-beta, Antigens, CD19, Graft vs Host Disease etiology, Graft vs Host Disease prevention & control
Abstract

Abstract: HLA-mismatched transplants with either in vitro depletion of CD3+ T-cell receptor (TCR)αβ/CD19 (TCRαβ) cells or in vivo T-cell depletion using posttransplant cyclophosphamide (PTCY) have been increasingly used for patients with inborn errors of immunity (IEIs). We performed a retrospective multicenter study via the EBMT registry on 306 children with IEIs undergoing their first transplant between 2010 and 2019 from an HLA-mismatched donor using TCRαβ (n = 167) or PTCY (n = 139). The median age for hematopoietic stem cell transplantation (HSCT) was 1.2 years (range, 0.03-19.6 years). The 3-year overall survival (OS) was 78% (95% confidence interval (CI), 71-84) after TCRαβ and 66% (57-74) after PTCY (P = .013). Pre-HSCT morbidity score (hazard ratio [HR], 2.27; 1.07-4.80, P = .032) and non-busulfan/treosulfan conditioning (HR, 3.12; 1.98-4.92, P < .001) were the only independent predictors of unfavorable OS. The 3-year event-free survival (EFS) was 58% (50%-66%) after TCRαβ and 57% (48%-66%) after PTCY (P = .804). The cumulative incidence of severe acute graft-versus-host disease (GvHD) was higher after PTCY (15%, 9%-21%) than TCRαβ (6%, 2%-9%, P = .007), with no difference in chronic GvHD (PTCY, 11%, 6%-17%; TCRαβ, 7%, 3%-11%, P = .173). The 3-year GvHD-free EFS was 53% (44%-61%) after TCRαβ and 41% (32%-50%) after PTCY (P = .080). PTCY had significantly higher rates of veno-occlusive disease (14.4% vs TCRαβ 4.9%, P = .009), acute kidney injury (12.7% vs 4.6%, P = .032), and pulmonary complications (38.2% vs 24.1%, P = .017). Adenoviremia (18.3% vs PTCY 8.0%, P = .015), primary graft failure (10% vs 5%, P = .048), and second HSCT (17.4% vs 7.9%, P = .023) were significantly higher in TCRαβ. In conclusion, this study demonstrates that both approaches are suitable options in patients with IEIs, although they are characterized by different advantages and outcomes., (© 2024 American Society of Hematology. Published by Elsevier Inc. All rights are reserved, including those for text and data mining, AI training, and similar technologies.)

Published
2024
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