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NCT00382109 · ClinicalTrials.gov registry record · Phase 3
Tacrolimus and Methotrexate With or Without Sirolimus in Preventing Graft-Versus-Host Disease in Young Patients Undergoing Donor Stem Cell Transplant for Acute Lymphoblastic Leukemia in Complete Remission
A Phase 3 study, sponsored by Children's Oncology Group.
- Completed
- Registry status
- Phase 3
- Development phase
- 146
- Enrollment target
NCT00382109: Completed Phase 3 study, sponsored by Children's Oncology Group.
NCT00382109 is a Phase 3 study that has completed, run by Children's Oncology Group. The registered enrollment target is 146 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00382109, a Phase 3 study, has completed, sponsored by Children's Oncology Group.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 146 participants
- Enrollment target
Study Summary
This randomized phase III trial is studying tacrolimus, methotrexate, and sirolimus to see how well they work compared to tacrolimus and methotrexate in preventing graft-versus-host disease in young patients who are undergoing donor stem cell transplant for intermediate-risk or high-risk acute lymphoblastic leukemia in second complete remission and high risk acute lymphoblastic leukemia in first remission. Giving chemotherapy, such as thiotepa and cyclophosphamide, and total-body irradiation before a donor stem cell transplant helps stop the growth of cancer cells. It also helps 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, methotrexate, and sirolimus after the transplant may stop this from happening. It is not yet known whether tacrolimus and methotrexate are more effective with or without sirolimus in preventing graft-versus-host disease.
Primary Outcome
An event is defined as relapse or transplant-related mortality. Relapse is defined in section 3.3 study protocol.
Interventions
- DRUG cyclophosphamide
- DRUG tacrolimus
- DRUG sirolimus
- DRUG methotrexate
- DRUG thiotepa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 146 participants |
| Start Date | 2007-03 |
| Est. Completion | 2017-06-30 |
| Phase | Phase 3 |
What the finished NCT00382109 record still lists
NCT00382109 is an interventional study that assigns participants to a tested intervention. The registered 146 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 5 interventions - of which cyclophosphamide is the first listed.
NCT00382109 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00382109 about?
NCT00382109 is a clinical study titled "Tacrolimus and Methotrexate With or Without Sirolimus in Preventing Graft-Versus-Host Disease in Young Patients Undergoing Donor Stem Cell Transplant for Acute Lymphoblastic Leukemia in Complete Remission". This randomized phase III trial is studying tacrolimus, methotrexate, and sirolimus to see how well they work compared to tacrolimus and methotrexate in preventing graft-versus-host disease in young patients who are undergoing donor stem cell transplant for intermediate-risk or high-risk acute lymph...
What is the current status of trial NCT00382109?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 146 participants. The study started on 2007-03. Estimated completion is 2017-06-30.
What interventions are being tested in trial NCT00382109?
The interventions under investigation include: cyclophosphamide (DRUG), tacrolimus (DRUG), sirolimus (DRUG), methotrexate (DRUG), thiotepa (DRUG).
Who is sponsoring clinical trial NCT00382109?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00382109's enrollment target sits among peer trials
146 1551st of 2000 higher than 446 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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