Clinical trial
Iodine I 131 Monoclonal Antibody BC8, Fludarabine Phosphate, Total Body…
NCT00119366 · Fred Hutchinson Cancer Center, Other · Terminated
Key facts
| NCT number | NCT00119366 |
|---|---|
| Title | Iodine I 131 Monoclonal Antibody BC8, Fludarabine Phosphate, Total Body Irradiation, and Donor Stem Cell Transplant Followed by Cyclosporine and Mycophenolate Mofetil in Treating Patients With Advanced Acute Myeloid Leukemia or Myelodysplastic Syndrome |
| Official title | A Phase II Trial Combining Radiolabeled BC8 (Anti-CD45) Antibody With Fludarabine and Low Dose TBI Followed by Related or Unrelated PBSC Infusion and Post-Transplant Immunosuppression for Patients With Advanced AML or High Risk Myelodysplastic Syndrome |
| Lead sponsor | Fred Hutchinson Cancer Center, Other |
| Collaborators | National Cancer Institute (NCI) NIH |
| Status | Terminated |
| Phase | Phase 2 |
| Study type | Interventional |
| Conditions | 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, Adult Acute Myeloid Leukemia With t(8 and 12 more |
| Intervention type | Drug, Other, Procedure, Radiation |
| Interventions | iodine I 131 monoclonal antibody BC8, fludarabine phosphate, total-body irradiation, allogeneic hematopoietic stem cell transplantation, peripheral blood stem cell transplantation, cyclosporine, mycophenolate mofetil, laboratory biomarker analysis |
| Enrollment | 18 |
| Start date | May 1, 2003 |
| Primary completion | Aug 1, 2014 |
| Completion | May 8, 2019 |
| First posted | Jul 13, 2005 |
| Last update posted | Dec 12, 2022 |
| Countries | United States |
At a glance
- 1–9 Study sites
- Yes 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: