Low-Dose Total-Body Irradiation and Fludarabine Phosphate Followed by Unrelated Donor Stem Cell Transplant in Treating Patients With Fanconi Anemia

Completed · Phase 1

Conditions studied: Adult Acute Myeloid Leukemia in Remission, Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(15;17)(q22;q12), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Childhood Acute Myeloid Leukemia in Remission, Childhood Myelodysplastic Syndromes, Fanconi Anemia, Previously Treated Myelodysplastic Syndromes

In brief

Based on success in other diseases, the Fred Hutchinson Cancer Research Center (FHCRC) has developed a transplant procedure for Fanconi anemia (FA), which does not completely destroy the patient's remaining bone marrow. It should also be less harmful (toxic). Researchers wish to test whether this approach can overcome the graft failure often seen when bone marrow or peripheral blood stem cells from an unrelated donor are used. Researchers also will look at whether the procedure is less toxic than a conventional bone marrow transplant (BMT).

Key facts

Study ID

NCT00093743

Run by

Fred Hutchinson Cancer Center

People needed

2

Starts

2000-01-01

Last updated by the study team

2017-02-20

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Any patient with marrow failure and increased chromosome fragility as determined in the diepoxybutane (DEB) or mitomycin C test
• Any patient with Fanconi anemia (FA) with marrow failure meeting the following criteria:
• Granulocyte count < 0.2 x 10\^9/L
• Platelet count < 20 x 10\^9/L
• Hemoglobin < 8 g/dl
• Corrected reticulocyte count <1%
• Any patient with FA as determined by DEB fragility, who has life-threatening marrow failure involving a single hematopoietic lineage
• Any patient with FA and pre-existing cytogenetic abnormality including hematopoietic malignancy (myelodysplastic syndromes [MDS] or acute myeloid leukemia [AML]) in remission
• DONOR: Unrelated Donors who are prospectively: Matched for human lymphocyte antigen (HLA)-DRB1 and DQB1 alleles (must be defined by high resolution typing); only a single allele disparity will be allowed for HLA -A, B, or C as defined by high resolution typing
• DONOR: HLA typing will be performed at the highest level of resolution available at the time of transplant

You may not qualify if…

• Evidence for hematopoietic malignancy in relapse
• Heart or lung disease that would prevent compliance with conditioning and GvHD regimen or would severely limit the probability of survival
• Human immunodeficiency virus (HIV) seropositive patients
• Females who are pregnant or breastfeeding, or unwilling to use contraceptive techniques during and for the 12 months following treatment
• DONOR: Donors who by DEB testing are found to have FA
• DONOR: Donors who test positive in the lymphocytotoxic crossmatch assay
• DONOR: Donors who are HIV positive
• DONOR: Donors who for other medical or psychological reasons are not suitable as donors

Where it is running

• Robert H. Lurie Comprehensive Cancer Center — Chicago, Illinois, United States
• Riley Hospital for Children — Indianapolis, Indiana, United States
• Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States
• Huntsman Cancer Institute/University of Utah — Salt Lake City, Utah, United States
• Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium — Seattle, Washington, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.