Unmanipulated Haploidentical Reduced-Intensity Stem Cell Transplantation Using @entity3118 , XXXX , Low-Dose Antithymocyte Globulin, and Steroids for @entity1 in Non-Complete Remission or at High Risk of Relapse: A Prospective Multicenter Phase I/II Study in Japan.

@entity1 @entity1667 @entity3118 @entity2132 @entity1583 @entity1863 @entity1140 @entity204 @entity479
UNASSIGNED: This prospective, multicenter phase I/II study of unmanipulated HLA-haploidentical reduced-intensity stem cell  transplantation using a low dose of anti-T lymphocyte globulin (ATG) and @entity479 was conducted in 5 institutions in Japan. Thirty-four @entity1 with @entity1583 who were in an advanced stage or at a high risk of relapse at the time of transplantation were enrolled. Among them, 7 @entity1 underwent transplantation as a second transplantation because of relapse after the previous allogeneic stem cell transplantation. The conditioning regimen consisted of @entity3118 , @entity1863 , and ATG (Fresenius, 8 mg/kg), and @entity2132 ( @entity2132 ) prophylaxis consisted of @entity1140 and @entity1667 (1 mg/kg). All @entity1 except 1 (97.1%) achieved donor-type engraftment. Rapid hematopoietic engraftment was achieved, with neutrophils > .5  * 10(9)/L on day 11 and platelets > 20  * 10(9)/L on day 17.5. Treatment was started for >= grade I @entity2132 , and the cumulative incidences of acute grade I and grade II to IV @entity2132 were 27.5% and 30.7%, respectively. The incidence of chronic @entity2132 (extensive type) was 20%. Fourteen @entity1 (41.2%) had a relapse. The cumulative incidence of transplantation-related mortality at 1 year after transplantation was 26.5%. The  survival rate at day 100 was 88.2%. The survival rates at 1 year for @entity1 with complete remission (CR)/chronic phase (n  = 8) and non-CR (n  = 26) status before transplantation were 62.5% and 42.3%, respectively. In the multivariate analysis, non-CR status before transplantation was the only factor significant prognostic factor of increased relapse (P  = .0424), which tended to be associated with a lower survival rate (P  =  .0524). This transplantation protocol is safe and feasible, if a suitable donor is not available in a timely manner. As the main cause of @entity204 was relapse and not @entity2132 , more intensified conditioning or attenuation of @entity2132 prophylaxis and/or donor lymphocyte infusion may be desirable for @entity1 with non-CR status.
