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NCT00031655 · ClinicalTrials.gov registry record · Phase 2
Reduced Intensity Donor Stem Cell Transplant in Treating Patients With High Risk Acute Lymphocytic Leukemia in Complete Remission
A Phase 2 study, sponsored by Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium.
- Completed
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
NCT00031655: Completed Phase 2 study, sponsored by Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium.
NCT00031655 is a Phase 2 study that has completed, run by Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium. The registered enrollment target is 30 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00031655, a Phase 2 study, has completed, sponsored by Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
Study Summary
The reason for doing this study is to determine whether a new method of blood stem cell transplant (also known as bone marrow transplant) is able to treat acute lymphocytic leukemia. Blood stem cells are the "seed cells" necessary to make all blood cells. This new method of transplant uses a combination of low dose radiation and chemotherapy that may be less toxic and cause less harm than a conventional transplant. This lower dose transplant is called a "nonmyeloablative transplant". Researchers want to see if using less radiation and less chemotherapy combined with new immune suppressing drugs after the transplant will help a stem cell transplant to work. Researchers hope that this treatment will cure acute lymphocytic leukemia with fewer side effects. Researchers are hoping to see a mixture of recipient and donor blood cells after transplant. This mixture of donor and recipient blood cells is called "mixed chimerism". Researchers hope that donor cells will attack and eliminate the leukemia. This is called the "graft-versus-leukemia" effect. In addition, after the transplant, white blood cells from the donor may be given to enhance or "boost" the graft-versus-leukemia effect, and hopefully remove all remaining cancer cells. This study is being done because at the present time blood stem cell transplantation (or bone marrow transplantation) is the only known curative therapy for acute lymphocytic leukemia. Because of age or underlying health status acute lymphocytic leukemia patients have a higher likelihood of experiencing severe harm from a conventional blood stem cell transplant. Researchers are doing this study to see if this new nonmyeloablative method of low dose radiation and low dose chemotherapy given before transplant and immune suppressive drugs after transplant will help make the transplant safer and also cure acute lymphocytic leukemia
Primary Outcome
Incidence of survival without relapse. Kaplan-Meier estimates will be used to estimate one-year leukemia-free survival.
Interventions
- DRUG fludarabine phosphate
- DRUG cyclosporine
- RADIATION total-body irradiation
- PROCEDURE nonmyeloablative allogeneic hematopoietic stem cell transplantation
- BIOLOGICAL donor lymphocytes
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2001-09 |
| Est. Completion | 2012-11 |
| Phase | Phase 2 |
Sponsor
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium4 total trials
What the finished NCT00031655 record still lists
NCT00031655 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 5 interventions - of which fludarabine phosphate is the first listed.
NCT00031655 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00031655 about?
NCT00031655 is a clinical study titled "Reduced Intensity Donor Stem Cell Transplant in Treating Patients With High Risk Acute Lymphocytic Leukemia in Complete Remission". The reason for doing this study is to determine whether a new method of blood stem cell transplant (also known as bone marrow transplant) is able to treat acute lymphocytic leukemia. Blood stem cells are the "seed cells" necessary to make all blood cells. This new method of transplant uses a combina...
What is the current status of trial NCT00031655?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2001-09. Estimated completion is 2012-11.
What interventions are being tested in trial NCT00031655?
The interventions under investigation include: fludarabine phosphate (DRUG), cyclosporine (DRUG), total-body irradiation (RADIATION), nonmyeloablative allogeneic hematopoietic stem cell transplantation (PROCEDURE), donor lymphocytes (BIOLOGICAL).
Who is sponsoring clinical trial NCT00031655?
This trial is sponsored by Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00031655's enrollment target sits among peer trials
30 1582nd of 2000 higher than 332 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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