Title | Tacrolimus/sirolimus vs tacrolimus/methotrexate as GVHD prophylaxis after matched, related donor allogeneic HCT. |
Publication Type | Journal Article |
Year of Publication | 2014 |
Authors | Cutler, C, Logan, B, Nakamura, R, Johnston, L, Choi, S, Porter, D, Hogan, WJ, Pasquini, M, MacMillan, ML, Hsu, JW, Waller, EK, Grupp, S, McCarthy, P, Wu, J, Hu, Z-H, Carter, SL, Horowitz, MM, Antin, JH |
Journal | Blood |
Volume | 124 |
Issue | 8 |
Pagination | 1372-7 |
Date Published | 2014 Aug 21 |
ISSN | 1528-0020 |
Keywords | Adolescent, Adult, Allografts, Disease-Free Survival, Female, Follow-Up Studies, Graft vs Host Disease, Hematopoietic Stem Cell Transplantation, Humans, Immunosuppressive Agents, Male, Methotrexate, Middle Aged, Sirolimus, Stomatitis, Survival Rate, Tacrolimus, Time Factors |
Abstract | Grades 2-4 acute graft-versus-host disease (GVHD) occurs in approximately 35% of matched, related donor (MRD) allogeneic hematopoietic cell transplantation (HCT) recipients. We sought to determine if the combination of tacrolimus and sirolimus (Tac/Sir) was more effective than tacrolimus and methotrexate (Tac/Mtx) in preventing acute GVHD and early mortality after allogeneic MRD HCT in a phase 3, multicenter trial. The primary end point of the trial was to compare 114-day grades 2-4 acute GVHD-free survival using an intention-to-treat analysis of 304 randomized subjects. There was no difference in the probability of day 114 grades 2-4 acute GVHD-free survival (67% vs 62%, P = .38). Grades 2-4 GVHD was similar in the Tac/Sir and Tac/Mtx arms (26% vs 34%, P = .48). Neutrophil and platelet engraftment were more rapid in the Tac/Sir arm (14 vs 16 days, P |
DOI | 10.1182/blood-2014-04-567164 |
Alternate Journal | Blood |
PubMed ID | 24982504 |
PubMed Central ID | PMC4141519 |
Grant List | U10 HL069294 / HL / NHLBI NIH HHS / United States UG1 HL069286 / HL / NHLBI NIH HHS / United States U10 HL069290 / HL / NHLBI NIH HHS / United States U10 HL069278 / HL / NHLBI NIH HHS / United States U10 HL069301 / HL / NHLBI NIH HHS / United States U10 HL069330 / HL / NHLBI NIH HHS / United States U10 HL069291 / HL / NHLBI NIH HHS / United States U10 HL109137 / HL / NHLBI NIH HHS / United States U01 HL069294 / HL / NHLBI NIH HHS / United States U10 HL109322 / HL / NHLBI NIH HHS / United States P01 CA049605 / CA / NCI NIH HHS / United States U24 CA076518 / CA / NCI NIH HHS / United States U10 HL069286 / HL / NHLBI NIH HHS / United States U01HL069294 / HL / NHLBI NIH HHS / United States UG1 HL069278 / HL / NHLBI NIH HHS / United States U10 HL069249 / HL / NHLBI NIH HHS / United States |