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

Sponsor
Asan Medical Center
Study ID
NCT01509300
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

  • Acute Leukemia
  • Myelodysplastic Syndrome
  • Solid Tumors

Eligibility Criteria

Sex
ALL
Age
N/A - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • anti-thymocyte globulin — BIOLOGICAL
    On days -10 to -9
  • filgrastim — BIOLOGICAL
    Beginning on day 4 and continuing until blood counts recover
  • Total body irradiation — RADIATION
    2Gy D-6 to D-4
  • Fludarabine — DRUG
    30mg/M2 once daily IV on days -8 to -4
  • cyclophosphamide — DRUG
    60 mg/kg IV on day-3 and -2
  • Tacrolimus — DRUG
    begin on 0
  • Mycophenolate mofetil — DRUG
    begin on 0
  • Rituximab — DRUG
    375mg/m2 on day +21

Study Details

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.

Key Dates

Start date
Jan 31, 2012
Status verified
Jan 2012
Primary completion
Dec 31, 2013
Completion
Mar 31, 2014

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: HAPLO

Primary 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. [ Time Frame: 2 years post-transplant ]

Central Contacts

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