Status:
COMPLETED
Low-Dose Total-Body Irradiation and Fludarabine Phosphate Followed by Unrelated Donor Stem Cell Transplant in Treating Patients With Fanconi Anemia
Lead Sponsor:
Fred Hutchinson Cancer Center
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
National Cancer Institute (NCI)
Conditions:
Adult Acute Myeloid Leukemia in Remission
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Eligibility:
All Genders
Phase:
PHASE1
Brief Summary
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 rem...
Detailed Description
PRIMARY OBJECTIVES: I. To determine whether donor chimerism can be achieved in patients with Fanconi anemia receiving marrow or peripheral blood stem cell (PBSC) grafts from unrelated donors followin...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT00093743
Start Date
January 1 2000
Last Update
February 20 2017
Active Locations (5)
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1
Robert H. Lurie Comprehensive Cancer Center
Chicago, Illinois, United States, 60611
2
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
3
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
4
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States, 84112