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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
On days -10 to -9
Beginning on day 4 and continuing until blood counts recover
2Gy D-6 to D-4
30mg/M2 once daily IV on days -8 to -4
60 mg/kg IV on day-3 and -2
begin on 0
begin on 0
375mg/m2 on day +21
Asan Medical Center
Seoul, South Korea
RECRUITINGTransplantation-related mortality and overall survival of TBI, Fludarabine, Cyclophosphamide and anti-thymocyte globulin for engraftment of CD3 depleted haploidentical peripheral blood stem cells.
Time frame: 2 years post-transplant
Engraftment and graft failure rates
Number of patients who failed to stable engraftment by 28 days
Time frame: 28 days engraftment and graft failure
Incidence of acute GVHD
Number of patients with acute GVHD.
Time frame: 100 days post-transplant
Treatment related mortality
Number of death after transplantation
Time frame: 100 days post-transplant
Relapse rate and overall survival
Time frame: 2 year after transplantation
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