Clinical trial
Radiolabeled Monoclonal Antibody Therapy, Fludarabine Phosphate, and Low-Dose…
NCT00008177 · Fred Hutchinson Cancer Center, Other · Completed
Key facts
| NCT number | NCT00008177 |
|---|---|
| Title | Radiolabeled Monoclonal Antibody Therapy, Fludarabine Phosphate, and Low-Dose Total-Body Irradiation Followed by Donor Stem Cell Transplant and Immunosuppression Therapy in Treating Older Patients With Advanced Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndromes |
| Official title | A Phase I Study Combining Escalating Doses of Radiolabeled BC8 (Anti-CD45) Antibody With Fludarabine, Low Dose TBI, PBSC Infusion and Post-Transplant Immunosuppression With Cyclosporine and Mycophenolate Mofetil to Establish Mixed or Full Donor Chimerism for Elderly Patients With Advanced Acute… |
| Lead sponsor | Fred Hutchinson Cancer Center, Other |
| Collaborators | National Cancer Institute (NCI) NIH |
| Status | Completed |
| Phase | Phase 1 |
| Study type | Interventional |
| Conditions | 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 and 12 more |
| Intervention type | Drug, Other, Procedure, Radiation |
| Interventions | iodine I 131 monoclonal antibody BC8, total-body irradiation, allogeneic hematopoietic stem cell transplantation, peripheral blood stem cell transplantation, fludarabine phosphate, cyclosporine, mycophenolate mofetil, laboratory biomarker analysis |
| Enrollment | 79 |
| Start date | Jul 27, 1999 |
| Primary completion | Mar 21, 2009 |
| Completion | Dec 15, 2010 |
| First posted | Dec 12, 2003 |
| Last update posted | Nov 13, 2019 |
| Countries | United States |
At a glance
- 1–9 Study sites
- No Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: