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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


Phase 1/Phase 2
N/A
21 Years
Open (Enrolling)
Both
Acute Leukemia, Myelodysplastic Syndrome, Solid Tumors

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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

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