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NCT00040846 · ClinicalTrials.gov registry record · Phase 2
Alemtuzumab, Fludarabine Phosphate, and Low-Dose Total Body Irradiation Before Donor Stem Cell Transplantation in Treating Patients With Hematological Malignancies
A Phase 2 study, sponsored by Fred Hutchinson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
NCT00040846: Completed Phase 2 study, sponsored by Fred Hutchinson Cancer Center.
NCT00040846 is a Phase 2 study that has completed, run by Fred Hutchinson Cancer Center. The registered enrollment target is 60 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00040846, a Phase 2 study, has completed, sponsored by Fred Hutchinson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
Study Summary
This phase II trial studies the side effects and the best dose of alemtuzumab when given together with fludarabine phosphate and low-dose total body irradiation (TBI) and how well it works before donor stem cell transplant in treating patients with hematological malignancies. Giving chemotherapy and low-dose TBI before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. Also, monoclonal antibodies, such as alemtuzumab, can find cancer cells and either kill them or deliver cancer-killing substances to them without harming normal 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. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine (CSP) and mycophenolate mofetil (MMF) after transplant may stop this from happening.
Primary Outcome
Percentage patients with Day 100 transplant related mortality.
Interventions
- DRUG fludarabine phosphate
- BIOLOGICAL alemtuzumab
- PROCEDURE allogeneic hematopoietic stem cell transplantation
- PROCEDURE peripheral blood stem cell transplantation
- RADIATION total-body irradiation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2001-11 |
| Est. Completion | 2009-12 |
| Phase | Phase 2 |
What the finished NCT00040846 record still lists
NCT00040846 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 5 interventions - of which fludarabine phosphate is the first listed.
NCT00040846 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00040846 about?
NCT00040846 is a clinical study titled "Alemtuzumab, Fludarabine Phosphate, and Low-Dose Total Body Irradiation Before Donor Stem Cell Transplantation in Treating Patients With Hematological Malignancies". This phase II trial studies the side effects and the best dose of alemtuzumab when given together with fludarabine phosphate and low-dose total body irradiation (TBI) and how well it works before donor stem cell transplant in treating patients with hematological malignancies. Giving chemotherapy and...
What is the current status of trial NCT00040846?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2001-11. Estimated completion is 2009-12.
What interventions are being tested in trial NCT00040846?
The interventions under investigation include: fludarabine phosphate (DRUG), alemtuzumab (BIOLOGICAL), allogeneic hematopoietic stem cell transplantation (PROCEDURE), peripheral blood stem cell transplantation (PROCEDURE), total-body irradiation (RADIATION).
Who is sponsoring clinical trial NCT00040846?
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 NCT00040846's enrollment target sits among peer trials
60 1027th of 2000 higher than 868 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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