Acute Myeloid Leukemia Clinical Trial

Hematopoietic Stem Cell Transplant for Fanconi Anemia

Summary

The trial proposed is a single arm phase II treatment protocol designed to examine engraftment, toxicity, graft-versus-host disease, and ultimate disease-free survival following a novel cytoreductive regimen including busulfan, cyclophosphamide and fludarabine and anti-thymocyte globulin (ATG- a non-chemotherapy drug whose role is to kill your immune system) for the treatment of patients with Fanconi anemia who have severe aplastic anemia (SAA), or myelodysplastic syndrome (MDS) or acute myelogenous leukemia (AML), lacking HLA-genotypically identical donors using stem cell transplants derived from (1) HLA-compatible unrelated donors or (2) HLA haplotype-mismatched related donors.

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Full Description

We are currently recruiting patients.

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Eligibility Criteria

Inclusion Criteria:

Fanconi Anemia (confirmed by mitomycin C or DEB chromosomal breakage testing and one of the following hematological diagnoses: Severe Aplastic Anemia, Myelodysplastic Syndrome, Acute Myelogenous Leukemia
Karnofsky or Lansy performance scale > or = to 70%.
Must have adequate cardiac, hepatic, renal and pulmonary function.
Must have 7/8 or 8/8 available unrelated donor.

Exclusion Criteria:

Pregnant or breastfeeding.
Active CNS leukemic involvement
Active uncontrolled viral, bacterial or fungal infection
Positive for HIV.

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 2

Estimated Enrollment:

1

Study ID:

NCT01071239

Recruitment Status:

Completed

Sponsor:

Medical College of Wisconsin

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There is 1 Location for this study

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Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 2

Estimated Enrollment:

1

Study ID:

NCT01071239

Recruitment Status:

Completed

Sponsor:


Medical College of Wisconsin

How clear is this clinincal trial information?

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