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NCT00096161 · ClinicalTrials.gov registry record · Phase 2
Pentostatin and Lymphocyte Infusion in Preventing Graft Rejection in Patients Who Have Undergone Donor Stem Cell Transplant
A Phase 2 study, sponsored by Fred Hutchinson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
NCT00096161: Completed Phase 2 study, sponsored by Fred Hutchinson Cancer Center.
NCT00096161 is a Phase 2 study that has completed, run by Fred Hutchinson Cancer Center. The registered enrollment target is 36 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00096161, a Phase 2 study, has completed, sponsored by Fred Hutchinson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
Study Summary
This phase II trial studies pentostatin and donor lymphocyte infusion in preventing graft rejection in patients who have undergone donor stem cell transplant. Giving pentostatin and an infusion of the donor's T cells (donor lymphocyte infusion) after a donor stem cell transplant may stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving pentostatin before donor lymphocyte infusion may stop this from happening.
Primary Outcome
A regimen will be considered successful if 20 patients are enrolled, at least 13 demonstrate improved chimerism. If fewer than 5 patients have shown improvement in chimerism then it can be at least 75% confident that the true rate of improvement is less than 0.53. Enrollment to the regimen will stop and the next regimen will be opened. Enrollment to a regimen may also be stopped at any time it becomes impossible to achieve 5 of 10 or 13 of 20 successful improvements. "Chimerism" in hematopoieti
Interventions
- DRUG Mycophenolate Mofetil
- DRUG Cyclosporine
- DRUG Pentostatin
- BIOLOGICAL Therapeutic Allogeneic Lymphocytes
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2003-05 |
| Est. Completion | 2015-08 |
| Phase | Phase 2 |
What the finished NCT00096161 record still lists
NCT00096161 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 4 interventions - of which Mycophenolate Mofetil is the first listed.
NCT00096161 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00096161 about?
NCT00096161 is a clinical study titled "Pentostatin and Lymphocyte Infusion in Preventing Graft Rejection in Patients Who Have Undergone Donor Stem Cell Transplant". This phase II trial studies pentostatin and donor lymphocyte infusion in preventing graft rejection in patients who have undergone donor stem cell transplant. Giving pentostatin and an infusion of the donor's T cells (donor lymphocyte infusion) after a donor stem cell transplant may stop the patient...
What is the current status of trial NCT00096161?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2003-05. Estimated completion is 2015-08.
What interventions are being tested in trial NCT00096161?
The interventions under investigation include: Mycophenolate Mofetil (DRUG), Cyclosporine (DRUG), Pentostatin (DRUG), Therapeutic Allogeneic Lymphocytes (BIOLOGICAL).
Who is sponsoring clinical trial NCT00096161?
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 NCT00096161's enrollment target sits among peer trials
36 1496th of 2000 higher than 477 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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