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NCT00691015 · ClinicalTrials.gov registry record · Phase 2
Sirolimus, Tacrolimus, and Antithymocyte Globulin in Preventing Graft-Versus-Host Disease in Patients With Hematologic Cancer Who Are Undergoing Donor Stem Cell Transplant
A Phase 2 study, sponsored by Barbara Ann Karmanos Cancer Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 48
- Enrollment target
NCT00691015: Completed Phase 2 study, sponsored by Barbara Ann Karmanos Cancer Institute.
NCT00691015 is a Phase 2 study that has completed, run by Barbara Ann Karmanos Cancer Institute. The registered enrollment target is 48 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00691015, a Phase 2 study, has completed, sponsored by Barbara Ann Karmanos Cancer Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 48 participants
- Enrollment target
Study Summary
RATIONALE: Giving low doses of chemotherapy, monoclonal antibodies, and radiation therapy before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also 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 tacrolimus, sirolimus, and antithymocyte globulin before and after transplant may stop this from happening. PURPOSE: This phase II trial is studying the side effects of giving sirolimus together with tacrolimus and antithymocyte globulin and to see how well it works in preventing graft-versus-host disease in patients with hematologic cancer who are undergoing donor stem cell transplant.
Interventions
- DRUG cyclophosphamide
- BIOLOGICAL rituximab
- DRUG carmustine
- DRUG cytarabine
- DRUG busulfan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2008-05 |
| Est. Completion | 2014-04 |
| Phase | Phase 2 |
What the finished NCT00691015 record still lists
NCT00691015 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower).
The record links to 0 conditions, and to 5 interventions - of which cyclophosphamide is the first listed.
NCT00691015 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00691015 about?
NCT00691015 is a clinical study titled "Sirolimus, Tacrolimus, and Antithymocyte Globulin in Preventing Graft-Versus-Host Disease in Patients With Hematologic Cancer Who Are Undergoing Donor Stem Cell Transplant". RATIONALE: Giving low doses of chemotherapy, monoclonal antibodies, and radiation therapy before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace...
What is the current status of trial NCT00691015?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2008-05. Estimated completion is 2014-04.
What interventions are being tested in trial NCT00691015?
The interventions under investigation include: cyclophosphamide (DRUG), rituximab (BIOLOGICAL), carmustine (DRUG), cytarabine (DRUG), busulfan (DRUG).
Who is sponsoring clinical trial NCT00691015?
This trial is sponsored by Barbara Ann Karmanos Cancer Institute, which has 139 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00691015's enrollment target sits among peer trials
48 1265th of 2000 higher than 718 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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