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Reduced-Intensity Fludarabine, Melphalan, and Total Body Irradiation Conditioning for Transplantation of HLA-Haploidentical Related Hematopoietic Cells (Haplo-HCT) For Patients With Hematologic Malignancies
This is a single arm, phase II trial of HLA-haploidentical related hematopoietic cells transplant (Haplo-HCT) using reduced intensity conditioning (fludarabine and melphalan and total body irradiation). Peripheral blood is the donor graft source.
Primary Objective: The primary objective is to estimate probability of the 18 months DFS after a HLA-haploidentical related hematopoietic cells transplant (Haplo-HCT) using a reduced intensity conditioning regimen with fludarabine/melphalan/total body irradiation (TBI) conditioning for patients with advanced age or comorbidities. Secondary Objectives: > Incidence of day 100 grade II-IV and grade III-IV acute graft versus-host-disease (GVHD) * Probability of 6 month and 18 months treatment-related mortality (TRM) * Probability of 18 months relapse incidence * Probability of 18 months overall survival (OS)
Alkeran (Melphalan); Cellcept (Mycophenolate Mofetil); FK506 (Tacrolimus); G-CSF (); Melphalan (); Mycophenolate Mofetil (); Rapamune (Sirolimus); Rapamycin (Sirolimus); Sirolimus (); Tacrolimus (); cyclophosphamide (); cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate)