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NCT00416884 · ClinicalTrials.gov registry record · Phase 2
Flu,Alemtuzumab,and TBI Followed By Donor Stem Cell Chronic Phase CML
A Phase 2 study, sponsored by OHSU Knight Cancer Institute.
- Terminated
- Registry status
- Phase 2
- Development phase
- 1
- Enrollment target
NCT00416884: Clinical Trial Phase 2 study, sponsored by OHSU Knight Cancer Institute.
NCT00416884 is a Phase 2 study that was terminated before completion, run by OHSU Knight Cancer Institute. The registered enrollment target is 1 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00416884, a Phase 2 study, was terminated before completion, sponsored by OHSU Knight Cancer Institute.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 1 participants
- Enrollment target
Study Summary
RATIONALE: Giving low doses of chemotherapy, such as fludarabine, and total-body irradiation (TBI) before a donor stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) that have been treated in the laboratory after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine and alemtuzumab, and removing the T lymphocyte cells(T cells) from the donor cells before transplant, may stop this from happening. PURPOSE: This clinical trial is studying how well giving fludarabine, alemtuzumab, and total-body irradiation together with donor stem cell transplant and donor white blood cell (WBC) infusion works in treating patients with chronic phase chronic myelogenous leukemia (CML) that did not respond to previous imatinib mesylate.
Primary Outcome
Treatment related mortality is a consequence of both complications of the preparative regimen and systemic immunological rejection which is manifested as graft versus host disease(GVHD). The preparative regimens which include whole body radiation and/or high dose chemotherapy are complicated by single or multi-organ failure and by prolonged myelosuppression that can lead to infections and bleeding
Interventions
- DRUG Fludarabine
- RADIATION Total Body Irradiation (TBI)
- DRUG Campath
- OTHER T-Cell Deplete
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2003-05 |
| Est. Completion | 2008-03 |
| Phase | Phase 2 |
Why NCT00416884 stopped before completion
NCT00416884 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 4 interventions - of which Fludarabine is the first listed.
NCT00416884 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00416884 about?
NCT00416884 is a clinical study titled "Flu,Alemtuzumab,and TBI Followed By Donor Stem Cell Chronic Phase CML". RATIONALE: Giving low doses of chemotherapy, such as fludarabine, and total-body irradiation (TBI) before a donor stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patien...
What is the current status of trial NCT00416884?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 1 participants. The study started on 2003-05. Estimated completion is 2008-03.
What interventions are being tested in trial NCT00416884?
The interventions under investigation include: Fludarabine (DRUG), Total Body Irradiation (TBI) (RADIATION), Campath (DRUG), T-Cell Deplete (OTHER).
Who is sponsoring clinical trial NCT00416884?
This trial is sponsored by OHSU Knight Cancer Institute, which has 211 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00416884's enrollment target sits among peer trials
1 2001st of 2000 the lowest 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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