Study:
Killer Immunoglobulin-like Receptor (KIR) Incompatible Unrelated Donor Hematopoietic Cell Transplantation (SCT) for AML With Monosomy 7, -5/5q-, High FLT3-ITD AR, or Refractory and Relapsed Acute Myelogenous Leukemia (AML) in Children: A Children`s Oncology Group (COG) Study
Rationale:
Giving chemotherapy before a donor stem cell transplant using stem cells that
closely match the patient`s stem cells, helps stop the growth of cancer cells. It also stops
the patient`s immune system from rejecting the donor`s stem cells. The donated stem cells
may replace the patient`s immune cells and help destroy any remaining cancer cells
(graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an
immune response against the body`s normal cells. Giving antithymocyte globulin before
transplant and cyclosporine, tacrolimus, and methotrexate before and after transplant may
stop this from happening.
Purpose:
This phase II trial is studying donor stem cell transplant to see how well it works
in treating young patients with acute myeloid leukemia with monosomy 7, -5/5q-, high
FLT3-ITD AR, or refractory or relapsed acute myelogenous leukemia.
Study Status: Recruiting
Recruiting:
Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente 866-223-8100
| Condition |
Intervention |
Phase |
|
Leukemia |
Biological: anti-thymocyte globulin
Drug: busulfan
Drug: cyclophosphamide
Drug: cyclosporine
Drug: methotrexate
Drug: methylprednisolone
Drug: tacrolimus
Other: laboratory biomarker analysis
Other: pharmacological study
Procedure: allogeneic bone marrow transplantation |
Phase 2 |
Verified by
Children`s Oncology Group
April, 2011
Sponsored by: Children`s Oncology Group
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov identifier: NCT00553202
Study Type: Interventional
Study Design: Primary Purpose: Treatment
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio 44195
United States
Stella M. Davies, MBBS, PhD., Study Chair