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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 is a Phase 2 study that was terminated before completion, run by OHSU Knight Cancer Institute. The registered enrollment target is 1 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00416884
The ClinicalTrials.gov registry entry for NCT00416884 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is OHSU Knight Cancer Institute, which has 211 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Fludarabine is the first listed.
NCT00416884 reports 0 study locations.
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.
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