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NCT00787761 · ClinicalTrials.gov registry record · Phase 2
Early Administration of ATG Followed by Cyclophosphamide, Busulfan and Fludarabine Before a Donor Stem Cell Transplant in Patients With Hematological Cancer
A Phase 2 study, sponsored by Northside Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
NCT00787761: Completed Phase 2 study, sponsored by Northside Hospital.
NCT00787761 is a Phase 2 study that has completed, run by Northside Hospital. The registered enrollment target is 24 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00787761, a Phase 2 study, has completed, sponsored by Northside Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
Study Summary
RATIONALE: Giving low doses of chemotherapy before a donor 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 antithymocyte globulin before the transplant and tacrolimus and methotrexate after the transplant may stop this from happening. PURPOSE: This phase II trial is studying how well giving antithymocyte globulin together with cyclophosphamide, busulfan, and fludarabine works in treating patients with hematological cancer or kidney cancer undergoing donor stem cell transplant.
Primary Outcome
Chimerism analysis of peripheral blood mononuclear cells using PCR for STR/VNTR will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism.
Interventions
- DRUG cyclophosphamide
- DRUG fludarabine phosphate
- DRUG methotrexate
- DRUG busulfan
- BIOLOGICAL anti-thymocyte globulin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2007-04 |
| Est. Completion | 2012-05 |
| Phase | Phase 2 |
What the finished NCT00787761 record still lists
NCT00787761 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 5 interventions - of which cyclophosphamide is the first listed.
NCT00787761 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00787761 about?
NCT00787761 is a clinical study titled "Early Administration of ATG Followed by Cyclophosphamide, Busulfan and Fludarabine Before a Donor Stem Cell Transplant in Patients With Hematological Cancer". RATIONALE: Giving low doses of chemotherapy before a donor 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 canc...
What is the current status of trial NCT00787761?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2007-04. Estimated completion is 2012-05.
What interventions are being tested in trial NCT00787761?
The interventions under investigation include: cyclophosphamide (DRUG), fludarabine phosphate (DRUG), methotrexate (DRUG), busulfan (DRUG), anti-thymocyte globulin (BIOLOGICAL).
Who is sponsoring clinical trial NCT00787761?
This trial is sponsored by Northside Hospital, which has 26 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00787761's enrollment target sits among peer trials
24 1756th of 2000 higher than 217 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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