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

• Published in: Biology of blood and marrow transplantation 2014-03, Vol.20 (3), p.354-360
• Main Authors: Sauter, Craig S, Barker, Juliet N, Lechner, Lauren, Zheng, Junting, Devlin, Sean M, Papadopoulos, Esperanza B, Perales, Miguel-Angel, Jakubowski, Ann A, Goldberg, Jenna D, Koehne, Guenther, Ceberio, Izaskun, Giralt, Sergio, Zelenetz, Andrew D, Moskowitz, Craig H, Castro-Malaspina, Hugo
• Format: Article
• Language: English
• Subjects: Adult; Aged; Allogeneic stem cell transplant; Antibodies, Monoclonal, Murine-Derived - therapeutic use; Antineoplastic Agents - therapeutic use; Cyclophosphamide - therapeutic use; Female; Graft vs Host Disease - prevention & control; Hematology, Oncology and Palliative Medicine; Hematopoietic Stem Cell Transplantation; Humans; Lymphoma, B-Cell - immunology; Lymphoma, B-Cell - mortality; Lymphoma, B-Cell - pathology; Lymphoma, B-Cell - therapy; Male; Middle Aged; Non-Hodgkin lymphoma; Nonmyeloablative; Prospective Studies; Rituximab; Survival Analysis; Transplantation Chimera; Transplantation Conditioning - methods; Transplantation, Homologous; Treatment Outcome; Unrelated Donors; Vidarabine - analogs & derivatives; Vidarabine - therapeutic use; Whole-Body Irradiation
• ISSN: 1083-8791; 1523-6536
• DOI: 10.1016/j.bbmt.2013.11.029

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/m2 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