Trial Information
HLA-haploidentical Allogeneic Hematopoietic Cell Transplantation Using CD3 Depletion for Children and Adolescents With Acute Leukemia, Myelodysplastic Syndrome and Solid Tumors After Conditioning of TBI, Fludarabine, Cyclophosphamide and Antithymocyte Globulin
Inclusion 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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Transplantation-related mortality and overall survival of TBI, Fludarabine, Cyclophosphamide and anti-thymocyte globulin for engraftment of CD3 depleted haploidentical peripheral blood stem cells.
Outcome Time Frame:
2 years post-transplant
Safety Issue:
Yes
Principal Investigator
Ho Joon Im, MD & PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Asan Medical Center
Authority:
Korea: Institutional Review Board
Study ID:
AMCPHO-SCT0902
NCT ID:
NCT01509300
Start Date:
January 2012
Completion Date:
March 2014
Related Keywords:
- Acute Leukemia
- Myelodysplastic Syndrome
- Solid Tumors
- TBI
- Fludarabine
- CD3 depletion
- Children and adolescents
- Haploidentical hematopoietic stem cell transplantation
- Leukemia
- Myelodysplastic Syndromes
- Preleukemia
- Acute Disease
- Neoplasms