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NCT00988715 · ClinicalTrials.gov registry record · Phase 1
Donor Peripheral Blood Stem Cell Transplant and Pretargeted Radioimmunotherapy in Treating Patients With High-Risk Advanced Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, or Myelodysplastic Syndrome
A Phase 1 study, sponsored by Fred Hutchinson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
NCT00988715: Completed Phase 1 study, sponsored by Fred Hutchinson Cancer Center.
NCT00988715 is a Phase 1 study that has completed, run by Fred Hutchinson Cancer Center. The registered enrollment target is 17 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00988715, a Phase 1 study, has completed, sponsored by Fred Hutchinson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
Study Summary
This phase I trial studies pretargeted radioimmunotherapy and donor peripheral blood stem cell transplant employing fludarabine phosphate and total-body irradiation (TBI) to treat patients with high-risk acute myeloid leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome. Giving chemotherapy drugs, such as fludarabine phosphate, and TBI before a donor peripheral blood stem cell transplant helps stop the patient's immune system from rejecting the donor's stem cells. Radiolabeled monoclonal antibodies can be combined with fludarabine phosphate and TBI to find cancer cells and kill them without harming normal cells. Pretargeted radioimmunotherapy (PRIT) allows for further improved targeting of tumor cells over standard directly labeled antibodies.
Primary Outcome
Conducted by the "two-stage" approach introduced by Storer. The MTD will be defined as the dose of 90Y-DOTA-biotin used in combination with the non-myeloablative HCT conditioning regimen that is associated with a grade III/IV regimen related toxicity (RRT) or true DLT rate of 25%.
Interventions
- RADIATION Total-Body Irradiation
- DRUG Mycophenolate Mofetil
- DRUG Cyclosporine
- PROCEDURE Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation
- BIOLOGICAL Pretargeted Radioimmunotherapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2010-04-21 |
| Phase | Phase 1 |
What the finished NCT00988715 record still lists
NCT00988715 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 5 interventions - of which Total-Body Irradiation is the first listed.
NCT00988715 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00988715 about?
NCT00988715 is a clinical study titled "Donor Peripheral Blood Stem Cell Transplant and Pretargeted Radioimmunotherapy in Treating Patients With High-Risk Advanced Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, or Myelodysplastic Syndrome". This phase I trial studies pretargeted radioimmunotherapy and donor peripheral blood stem cell transplant employing fludarabine phosphate and total-body irradiation (TBI) to treat patients with high-risk acute myeloid leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome. Giving chemot...
What is the current status of trial NCT00988715?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2010-04-21.
What interventions are being tested in trial NCT00988715?
The interventions under investigation include: Total-Body Irradiation (RADIATION), Mycophenolate Mofetil (DRUG), Cyclosporine (DRUG), Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation (PROCEDURE), Pretargeted Radioimmunotherapy (BIOLOGICAL).
Who is sponsoring clinical trial NCT00988715?
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 NCT00988715's enrollment target sits among peer trials
17 1785th of 2000 higher than 215 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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