drugset / Trial / NCT01509300

HLA-haploidentical Hematopoietic Stem Cell Transplantation for Children and Adolescents With Acute Leukemia, Myelodysplastic Syndrome and Solid Tumors

NCT01509300

Phase 1/2 Unknown 10 enrolled Asan Medical Center
NaSingle-groupOpen-labelTreatment

Summary

RATIONALE: Conditioning with total body irradiation (TBI) and fludarabine, cyclophosphamide and anti-thymocyte globulin may induce the engraftment cross the immunologic barrier in the setting of HLA-haploidentical allogeneic hematopoietic cell transplantation. In addition, T-cell depletion may contribute to prevent developing severe acute graft versus host disease (GVHD) in haploidentical transplantation. PURPOSE: This phase I/II trial is to evaluate the safety and efficacy of TBI, fludarabine, cyclophosphamide and antithymocyte globulin with T-cell depleted graft from haploidentical donors in treating patients with acute leukemia and myelodysplastic syndrome.

Timeline

Start
2012-01
Primary completion
2013-12
Completion
2014-03

Drugs

EvaluationDrugModalityDoseRoute
Subject ANTILYMPHOCYTE IMMUNOGLOBULIN (HORSE) Protein / enzyme biologic
Subject Cyclophosphamide Other / unclassified 60 mg/kg Intravenous
Subject Fludarabine Small molecule 30 mg/m2 Intravenous
Background Mycophenolate Mofetil Small molecule
Background Rituximab Monoclonal antibody 375 mg/m2
Background Tacrolimus Small molecule
Background filgrastim Protein / enzyme biologic