Allogeneic Stem Cell Transplantation for Relapsed/Refractory B Cell Lymphomas: Results of a Multicenter Phase II Prospective Trial including Rituximab in the Reduced-Intensity Conditioning Regimen

Anna Dodero, Francesca Patriarca, Giuseppe Milone, Barbara Sarina, Rosalba Miceli, Anna Iori, Francesco Barretta, Elisabetta Terruzzi, Alberto Mussetti, Massimo Pini, Alberto Bosi, Alida Dominietto, Nicola Cascavilla, Francesco Onida, Franco Narni, Lucia Farina, Alessandro Rambaldi, Paolo Corradini

Research output: Contribution to journalArticle

Abstract

The treatment of patients with refractory/relapsed B cell non-Hodgkin lymphoma (NHL) is evolving because of the availability of novel drugs. Allogeneic stem cell transplantation (alloSCT) can be curative, but its morbidity and mortality remain a matter of concern. We conducted a multicenter prospective phase II trial to evaluate the benefit of including only 1 dose of rituximab in the conditioning regimen before alloSCT. The primary endpoint was progression-free survival. The study enrolled 121 patients with relapsed/refractory B cell lymphomas. The conditioning regimen consisted of thiotepa, cyclophosphamide, fludarabine, and rituximab (500 mg/m2). Rabbit antithymocyte globulin was administered only in case of unrelated donors. Sixty-seven (55%) and 54 (45%) patients received grafts from related and unrelated donors, respectively. The crude cumulative incidence (CCI) of nonrelapse mortality (NRM) was 21% at 3 years. The CCIs of chronic graft-verus-host disease (GVHD) at 3 years were 54% and 31% in recipients of matched sibling and unrelated grafts, respectively. At a median follow-up of 41 months, the estimated 3-year progression-free and overall survival were 50% and 61%, respectively. Long-term outcome was also evaluated with the composite endpoint of GVHD-free and relapse-free survival (GRFS). This is the first work evaluating the GRFS in a prospective trial of lymphoma patients: the 1-year and 3-year GRFS were 40% and 34%, respectively. AlloSCT can cure a fraction of patients with rather low NRM and an encouraging PFS and GRFS.

Original languageEnglish
Pages (from-to)1102-1109
Number of pages8
JournalBiology of Blood and Marrow Transplantation
Volume23
Issue number7
DOIs
Publication statusPublished - Jul 2017

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Stem Cell Transplantation
B-Cell Lymphoma
Transplants
Recurrence
Unrelated Donors
Survival
Disease-Free Survival
Mortality
Thiotepa
Antilymphocyte Serum
Non-Hodgkin's Lymphoma
Cyclophosphamide
Siblings
Lymphoma
Rituximab
Conditioning (Psychology)
Rabbits
Morbidity
Incidence
Pharmaceutical Preparations

Keywords

  • Journal Article

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Allogeneic Stem Cell Transplantation for Relapsed/Refractory B Cell Lymphomas : Results of a Multicenter Phase II Prospective Trial including Rituximab in the Reduced-Intensity Conditioning Regimen. / Dodero, Anna; Patriarca, Francesca; Milone, Giuseppe; Sarina, Barbara; Miceli, Rosalba; Iori, Anna; Barretta, Francesco; Terruzzi, Elisabetta; Mussetti, Alberto; Pini, Massimo; Bosi, Alberto; Dominietto, Alida; Cascavilla, Nicola; Onida, Francesco; Narni, Franco; Farina, Lucia; Rambaldi, Alessandro; Corradini, Paolo.

In: Biology of Blood and Marrow Transplantation, Vol. 23, No. 7, 07.2017, p. 1102-1109.

Research output: Contribution to journalArticle

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abstract = "The treatment of patients with refractory/relapsed B cell non-Hodgkin lymphoma (NHL) is evolving because of the availability of novel drugs. Allogeneic stem cell transplantation (alloSCT) can be curative, but its morbidity and mortality remain a matter of concern. We conducted a multicenter prospective phase II trial to evaluate the benefit of including only 1 dose of rituximab in the conditioning regimen before alloSCT. The primary endpoint was progression-free survival. The study enrolled 121 patients with relapsed/refractory B cell lymphomas. The conditioning regimen consisted of thiotepa, cyclophosphamide, fludarabine, and rituximab (500 mg/m2). Rabbit antithymocyte globulin was administered only in case of unrelated donors. Sixty-seven (55{\%}) and 54 (45{\%}) patients received grafts from related and unrelated donors, respectively. The crude cumulative incidence (CCI) of nonrelapse mortality (NRM) was 21{\%} at 3 years. The CCIs of chronic graft-verus-host disease (GVHD) at 3 years were 54{\%} and 31{\%} in recipients of matched sibling and unrelated grafts, respectively. At a median follow-up of 41 months, the estimated 3-year progression-free and overall survival were 50{\%} and 61{\%}, respectively. Long-term outcome was also evaluated with the composite endpoint of GVHD-free and relapse-free survival (GRFS). This is the first work evaluating the GRFS in a prospective trial of lymphoma patients: the 1-year and 3-year GRFS were 40{\%} and 34{\%}, respectively. AlloSCT can cure a fraction of patients with rather low NRM and an encouraging PFS and GRFS.",
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T1 - Allogeneic Stem Cell Transplantation for Relapsed/Refractory B Cell Lymphomas

T2 - Results of a Multicenter Phase II Prospective Trial including Rituximab in the Reduced-Intensity Conditioning Regimen

AU - Dodero, Anna

AU - Patriarca, Francesca

AU - Milone, Giuseppe

AU - Sarina, Barbara

AU - Miceli, Rosalba

AU - Iori, Anna

AU - Barretta, Francesco

AU - Terruzzi, Elisabetta

AU - Mussetti, Alberto

AU - Pini, Massimo

AU - Bosi, Alberto

AU - Dominietto, Alida

AU - Cascavilla, Nicola

AU - Onida, Francesco

AU - Narni, Franco

AU - Farina, Lucia

AU - Rambaldi, Alessandro

AU - Corradini, Paolo

N1 - Copyright © 2017 The American Society for Blood and Marrow Transplantation. Published by Elsevier Inc. All rights reserved.

PY - 2017/7

Y1 - 2017/7

N2 - The treatment of patients with refractory/relapsed B cell non-Hodgkin lymphoma (NHL) is evolving because of the availability of novel drugs. Allogeneic stem cell transplantation (alloSCT) can be curative, but its morbidity and mortality remain a matter of concern. We conducted a multicenter prospective phase II trial to evaluate the benefit of including only 1 dose of rituximab in the conditioning regimen before alloSCT. The primary endpoint was progression-free survival. The study enrolled 121 patients with relapsed/refractory B cell lymphomas. The conditioning regimen consisted of thiotepa, cyclophosphamide, fludarabine, and rituximab (500 mg/m2). Rabbit antithymocyte globulin was administered only in case of unrelated donors. Sixty-seven (55%) and 54 (45%) patients received grafts from related and unrelated donors, respectively. The crude cumulative incidence (CCI) of nonrelapse mortality (NRM) was 21% at 3 years. The CCIs of chronic graft-verus-host disease (GVHD) at 3 years were 54% and 31% in recipients of matched sibling and unrelated grafts, respectively. At a median follow-up of 41 months, the estimated 3-year progression-free and overall survival were 50% and 61%, respectively. Long-term outcome was also evaluated with the composite endpoint of GVHD-free and relapse-free survival (GRFS). This is the first work evaluating the GRFS in a prospective trial of lymphoma patients: the 1-year and 3-year GRFS were 40% and 34%, respectively. AlloSCT can cure a fraction of patients with rather low NRM and an encouraging PFS and GRFS.

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VL - 23

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JO - Biology of Blood and Marrow Transplantation

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ER -