drugset / Trial / NCT00093743
Low-Dose Total-Body Irradiation and Fludarabine Phosphate Followed by Unrelated Donor Stem Cell Transplant in Treating Patients With Fanconi Anemia
Phase 1
Completed
2 enrolled
Fred Hutchinson Cancer Center
National Cancer Institute (NCI) · collabNational Heart, Lung, and Blood Institute (NHLBI) · collab
NaSingle-groupOpen-labelTreatment
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 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).
Timeline
- Start
- 2000-01
- Primary completion
- 2007-09
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Background | Cyclosporine | Peptide | — | Intravenous |
| Background | Fludarabine | Small molecule | — | Intravenous |
| Background | Mycophenolate Mofetil | Small molecule | — | Oral |
Indications
Fanconi anemia
acute myeloid leukemia with 11q23 abnormalities
acute myeloid leukemia with t(8;21)(q22;q22) translocation
acute myeloid leukemia, del(5q31-q32)
acute myeloid leukemia, inv(16)(p13.1;q22)
acute myeloid leukemia, t(16;16)(p13.1;q22)
childhood acute myeloid leukemia
childhood myelodysplastic syndrome