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

• Status: Unknown status
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Asan Medical Center
• Treatments: Antilymphocyte Serum; Cyclophosphamide; Fludarabine; Fludarabine phosphate; Mycophenolate mofetil; Mycophenolic Acid; Rituximab; Tacrolimus; Vidarabine

Criteria

Inclusion Criteria

1. Disease characteristics

• Acute lymphoblastic leukemia (first remission, high risk; beyond first remission; refractory)

• Acute myeloblastic leukemia (first remission, high risk; beyond first remission; refractory)

• Myelodysplastic syndrome

• Solid tumors (Refractory/relapse)

2. No HLA-identical family member or closely matched (8 or 7 of 8 HLA-locus match) unrelated marrow donor available

3. HLA-haploidentical related donor available

Exclusion criteria

1. Active fungal infections

2. HIV positive

3. Pregnant or nursing