title: A phase II study of a nonmyeloablative allogeneic stem cell transplant with peritransplant rituximab in patients with B cell lymphoid malignancies: favorably durable event-free survival in chemosensitive patients.
abstract: The aim of this prospective phase II trial was to determine the safety and efficacy of a nonmyeloablative conditioning program incorporating peritransplant rituximab in patients with CD20+ B cell non-Hodgkin lymphoma (B-NHL) receiving an allogeneic stem cell transplant (allo-SCT). Fifty-one adult B-NHL patients, with a median age of 54 years, were treated with cyclophosphamide, fludarabine, and 200 cGy of total body irradiation. Rituximab 375 mg/m(2) was given on day -8 and in 4 weekly doses beginning day +21. Equine antithymocyte globulin was given to recipients of volunteer unrelated donor grafts. Graft-versus-host disease (GVHD) prophylaxis consisted of cyclosporine and mycophenolate mofetil and tacrolimus, sirolimus, and methotrexate in 8 and 43 patients, respectively. Thirty-three patients received grafts from unrelated donors, and 18 received grafts from matched related donors. All patients engrafted. Full donor chimerism in bone marrow and peripheral T cells was seen in 92% and 89% of patients, respectively, at 3 months after allo-SCT. The cumulative incidence of grades II to IV acute GVHD at 6 months was 25% (95% confidence interval [CI], 13% to 38%) and grades III to IV was 11% (95% CI, 2% to 20%). The 2-year cumulative incidence of chronic GVHD was 29% (95% CI, 15% to 44%). The 2-year event-free and overall survival for all patients was 72% (95% CI, 59% to 85%) and 78% (95% CI, 66% to 90%), respectively. The 2-year event-free survival for chemosensitive patients was 84% (95% CI, 72% to 96%) compared with 30% (95% CI, 2% to 58%) for chemorefractory patients before allo-SCT (P < .001). This nonmyeloablative regimen, with peritransplant rituximab, is safe and effective in patients with B-NHL.
authors: Adult Bone Marrow Transplant Service, Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, New York; Department of Medicine, Weill Cornell Medical College, New York, New York. Electronic address: sauterc@mskcc.org.
authors: Craig S
authors: CS
authors: Sauter
authors: Adult Bone Marrow Transplant Service, Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, New York; Department of Medicine, Weill Cornell Medical College, New York, New York.
authors: Juliet N
authors: JN
authors: Barker
authors: Adult Bone Marrow Transplant Service, Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, New York.
authors: Lauren
authors: L
authors: Lechner
authors: Department of Biostatistics and Epidemiology, Memorial Sloan-Kettering Cancer Center, New York, New York.
authors: Junting
authors: J
authors: Zheng
authors: Department of Biostatistics and Epidemiology, Memorial Sloan-Kettering Cancer Center, New York, New York.
authors: Sean M
authors: SM
authors: Devlin
authors: Adult Bone Marrow Transplant Service, Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, New York; Department of Medicine, Weill Cornell Medical College, New York, New York.
authors: Esperanza B
authors: EB
authors: Papadopoulos
authors: Adult Bone Marrow Transplant Service, Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, New York; Department of Medicine, Weill Cornell Medical College, New York, New York.
authors: Miguel-Angel
authors: MA
authors: Perales
authors: Adult Bone Marrow Transplant Service, Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, New York; Department of Medicine, Weill Cornell Medical College, New York, New York.
authors: Ann A
authors: AA
authors: Jakubowski
authors: Adult Bone Marrow Transplant Service, Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, New York; Department of Medicine, Weill Cornell Medical College, New York, New York.
authors: Jenna D
authors: JD
authors: Goldberg
authors: Adult Bone Marrow Transplant Service, Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, New York; Department of Medicine, Weill Cornell Medical College, New York, New York.
authors: Guenther
authors: G
authors: Koehne
authors: Adult Bone Marrow Transplant Service, Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, New York; Hematology Department of Complejo Hospitalario de Navarra, Pamplona, Spain.
authors: Izaskun
authors: I
authors: Ceberio
authors: Adult Bone Marrow Transplant Service, Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, New York; Department of Medicine, Weill Cornell Medical College, New York, New York.
authors: Sergio
authors: S
authors: Giralt
authors: Department of Medicine, Weill Cornell Medical College, New York, New York; Lymphoma Service, Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, New York.
authors: Andrew D
authors: AD
authors: Zelenetz
authors: Adult Bone Marrow Transplant Service, Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, New York; Department of Medicine, Weill Cornell Medical College, New York, New York; Lymphoma Service, Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, New York.
authors: Craig H
authors: CH
authors: Moskowitz
authors: Adult Bone Marrow Transplant Service, Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, New York; Department of Medicine, Weill Cornell Medical College, New York, New York.
authors: Hugo
authors: H
authors: Castro-Malaspina
mesh_terms: D000328:Adult; D000368:Aged; D058846:Antibodies, Monoclonal, Murine-Derived / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D003520:Cyclophosphamide / Q000627:therapeutic use; D005260:Female; D006086:Graft vs Host Disease / Q000517:prevention & control; D018380:Hematopoietic Stem Cell Transplantation; D006801:Humans; D016393:Lymphoma, B-Cell / Q000276:immunology / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D000069283:Rituximab; D016019:Survival Analysis; D018183:Transplantation Chimera; D019172:Transplantation Conditioning / Q000379:methods*; D014184:Transplantation, Homologous; D016896:Treatment Outcome; D061349:Unrelated Donors; D014740:Vidarabine / Q000031:analogs & derivatives / Q000627:therapeutic use; D014916:Whole-Body Irradiation
chemical_list: D058846:Antibodies, Monoclonal, Murine-Derived; D000970:Antineoplastic Agents; D000069283:Rituximab; D003520:Cyclophosphamide; D014740:Vidarabine; C024352:fludarabine
keywords: Allogeneic stem cell transplant; Non-Hodgkin lymphoma; Nonmyeloablative; Rituximab