A Phase II study of a nonmyeloablative allogeneic stem cell transplant with peritransplant rituximab in patients with BCell lymphoid malignancies: Favorably durable event-free survival in chemosensitive patients Journal Article

   

Authors:	Sauter, C. S.; Barker, J. N.; Lechner, L.; Zheng, J.; Devlin, S. M.; Papadopoulos, E. B.; Perales, M. A.; Jakubowski, A. A.; Goldberg, J. D.; Koehne, G.; Ceberio, I.; Giralt, S.; Zelenetz, A. D.; Moskowitz, C. H.; Castro-Malaspina, H.
Article Title:	A Phase II study of a nonmyeloablative allogeneic stem cell transplant with peritransplant rituximab in patients with BCell 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 54years, were treated with cyclophosphamide, fludarabine, and 200cGy of total body irradiation. Rituximab 375mg/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 3months after allo-SCT. The cumulative incidence of grades II to IV acute GVHD at 6months 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. © 2014 American Society for Blood and Marrow Transplantation.
Keywords:	adult; controlled study; event free survival; aged; major clinical study; overall survival; fludarabine; neutropenia; treatment duration; methotrexate; rituximab; follow up; prospective study; t lymphocyte; phase 2 clinical trial; bone marrow; thrombocytopenia; cyclophosphamide; chemosensitivity; alanine aminotransferase blood level; fever; chimera; alanine aminotransferase; b cell lymphoma; acute graft versus host disease; chronic graft versus host disease; engraftment; nonmyeloablative conditioning; whole body radiation; prophylaxis; patient safety; donor lymphocyte infusion; clinical effectiveness; large cell lymphoma; cd4 lymphocyte count; recombinant granulocyte colony stimulating factor; tacrolimus; mycophenolic acid 2 morpholinoethyl ester; rapamycin; ganciclovir; cytomegalovirus infection; cyclosporin; thymocyte antibody; stevens johnson syndrome; non-hodgkin lymphoma; valganciclovir; nonmyeloablative stem cell transplantation; unrelated donors; allogeneic stem cell transplant; human; male; female; article; nonmyeloablative
Journal Title:	Biology of Blood and Marrow Transplantation
Volume:	20
Issue:	3
ISSN:	1083-8791
Publisher:	Elsevier Inc.
Date Published:	2014-03-01
Start Page:	354
End Page:	360
Language:	English
DOI:	10.1016/j.bbmt.2013.11.029
PROVIDER:	scopus
PUBMED:	24315843
PMCID:	PMC4374345
DOI/URL:	http://www.scopus.com/inward/record.url?eid=2-s2.0-84896846970&partnerID=40&md5=60ae405c181463a1a515c3bd036d8e14
Notes:	Export Date: 2 April 2014 -- CODEN: BBMTF -- Source: Scopus

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