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NCT00376480 · ClinicalTrials.gov registry record · Phase 1
Laboratory-Treated Lymphocyte Infusion After Haploidentical Donor Stem Cell Transplant
A Phase 1 study, sponsored by Dana-Farber Cancer Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
NCT00376480: Completed Phase 1 study, sponsored by Dana-Farber Cancer Institute.
NCT00376480 is a Phase 1 study that has completed, run by Dana-Farber Cancer Institute. The registered enrollment target is 19 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00376480, a Phase 1 study, has completed, sponsored by Dana-Farber Cancer Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
Study Summary
RATIONALE: Giving total-body irradiation and chemotherapy, such as thiotepa and fludarabine, before a donor stem cell transplant helps stop the growth of cancer or abnormal cells. It also helps stop the patient's immune system from rejecting the donor's stem 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 make an immune response against the body's normal cells. Giving methylprednisolone and antithymocyte globulin before transplant and peripheral blood cells that have been treated in the laboratory after transplant may stop this from happening. PURPOSE: This phase I trial is studying the side effects and best dose of laboratory-treated peripheral blood cell infusion after donor stem cell transplant in treating patients with hematologic cancers or other diseases.
Primary Outcome
ability to collect sufficient cells, make anergized product with good viability, without contamination and infuse per study toxicity of the conditioning regimen, the likelihood of engraftment, and the subsequent percentage of individuals who would be eligible to receive aDLI were determined.
Interventions
- DRUG methylprednisolone
- DRUG fludarabine phosphate
- DRUG thiotepa
- BIOLOGICAL anti-thymocyte globulin
- BIOLOGICAL peripheral blood lymphocyte therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2005-06 |
| Est. Completion | 2018-05-16 |
| Phase | Phase 1 |
What the finished NCT00376480 record still lists
NCT00376480 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 5 interventions - of which methylprednisolone is the first listed.
NCT00376480 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00376480 about?
NCT00376480 is a clinical study titled "Laboratory-Treated Lymphocyte Infusion After Haploidentical Donor Stem Cell Transplant". RATIONALE: Giving total-body irradiation and chemotherapy, such as thiotepa and fludarabine, before a donor stem cell transplant helps stop the growth of cancer or abnormal cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a...
What is the current status of trial NCT00376480?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2005-06. Estimated completion is 2018-05-16.
What interventions are being tested in trial NCT00376480?
The interventions under investigation include: methylprednisolone (DRUG), fludarabine phosphate (DRUG), thiotepa (DRUG), anti-thymocyte globulin (BIOLOGICAL), peripheral blood lymphocyte therapy (BIOLOGICAL).
Who is sponsoring clinical trial NCT00376480?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00376480's enrollment target sits among peer trials
19 1716th of 2000 higher than 281 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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