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NCT00104975 · ClinicalTrials.gov registry record · Phase 1
Alemtuzumab and Combination Chemotherapy Followed By Donor Lymphocytes in Treating Patients Who Are Undergoing Donor Stem Cell Transplant for Hematologic Cancer
A Phase 1 study, sponsored by Yale University.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT00104975: Completed Phase 1 study, sponsored by Yale University.
NCT00104975 is a Phase 1 study that has completed, run by Yale University. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00104975, a Phase 1 study, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
RATIONALE: Giving low doses of chemotherapy before a donor peripheral blood 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 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 tacrolimus before and after transplant may stop this from happening. PURPOSE: This phase I trial is studying the side effects and best dose of donor lymphocytes when given after alemtuzumab and combination chemotherapy in treating patients who are undergoing donor stem cell transplant for hematologic cancer.
Interventions
- DRUG fludarabine phosphate
- DRUG tacrolimus
- BIOLOGICAL alemtuzumab
- DRUG melphalan
- BIOLOGICAL therapeutic allogeneic lymphocytes
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2005-02 |
| Est. Completion | 2008-05 |
| Phase | Phase 1 |
What the finished NCT00104975 record still lists
NCT00104975 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 5 interventions - of which fludarabine phosphate is the first listed.
NCT00104975 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00104975 about?
NCT00104975 is a clinical study titled "Alemtuzumab and Combination Chemotherapy Followed By Donor Lymphocytes in Treating Patients Who Are Undergoing Donor Stem Cell Transplant for Hematologic Cancer". RATIONALE: Giving low doses of chemotherapy before a donor peripheral blood 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...
What is the current status of trial NCT00104975?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2005-02. Estimated completion is 2008-05.
What interventions are being tested in trial NCT00104975?
The interventions under investigation include: fludarabine phosphate (DRUG), tacrolimus (DRUG), alemtuzumab (BIOLOGICAL), melphalan (DRUG), therapeutic allogeneic lymphocytes (BIOLOGICAL).
Who is sponsoring clinical trial NCT00104975?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00104975's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 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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