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NCT00008177 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study, sponsored by Fred Hutchinson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 79
- Enrollment target
NCT00008177: Completed Phase 1 study, sponsored by Fred Hutchinson Cancer Center.
NCT00008177 is a Phase 1 study that has completed, run by Fred Hutchinson Cancer Center. The registered enrollment target is 79 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (32% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00008177, a Phase 1 study, has completed, sponsored by Fred Hutchinson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 79 participants
- Enrollment target
Study Summary
This phase I trial studies the side effects and best dose of iodine I 131 monoclonal antibody BC8 when given together with fludarabine phosphate and low-dose total-body irradiation followed by donor stem cell transplant and immunosuppression therapy in treating older patients with acute myeloid leukemia or high-risk myelodysplastic syndromes that cannot be controlled with treatment. Radiolabeled monoclonal antibodies, such as iodine I 131 monoclonal antibody BC8, can find cancer cells and carry cancer-killing substances to them. Giving chemotherapy, such as fludarabine phosphate, and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cancer or abnormal cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. The donated stem cells may also replace the patient's immune cells and help destroy any remaining cancer cells. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving radiolabeled monoclonal antibody therapy together with fludarabine phosphate and total-body irradiation before the transplant together with cyclosporine and mycophenolate mofetil after the transplant may stop this from happening.
Interventions
- DRUG fludarabine phosphate
- PROCEDURE allogeneic hematopoietic stem cell transplantation
- PROCEDURE peripheral blood stem cell transplantation
- RADIATION total-body irradiation
- RADIATION iodine I 131 monoclonal antibody BC8
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 79 participants |
| Start Date | 1999-07-27 |
| Est. Completion | 2010-12-15 |
| Phase | Phase 1 |
What the finished NCT00008177 record still lists
NCT00008177 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 79 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (32% higher).
The record links to 0 conditions, and to 5 interventions - of which fludarabine phosphate is the first listed.
NCT00008177 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00008177 about?
NCT00008177 is a clinical study titled "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". This phase I trial studies the side effects and best dose of iodine I 131 monoclonal antibody BC8 when given together with fludarabine phosphate and low-dose total-body irradiation followed by donor stem cell transplant and immunosuppression therapy in treating older patients with acute myeloid leuk...
What is the current status of trial NCT00008177?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 79 participants. The study started on 1999-07-27. Estimated completion is 2010-12-15.
What interventions are being tested in trial NCT00008177?
The interventions under investigation include: fludarabine phosphate (DRUG), allogeneic hematopoietic stem cell transplantation (PROCEDURE), peripheral blood stem cell transplantation (PROCEDURE), total-body irradiation (RADIATION), iodine I 131 monoclonal antibody BC8 (RADIATION).
Who is sponsoring clinical trial NCT00008177?
This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00008177's enrollment target sits among peer trials
79 696th of 2000 higher than 1,304 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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