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NCT00245037 · ClinicalTrials.gov registry record · Phase 1
Busulfan, Fludarabine, and Total-Body Irradiation in Treating Patients Who Are Undergoing a Donor Stem Cell Transplant for Hematologic Cancer
A Phase 1 study, sponsored by OHSU Knight Cancer Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 147
- Enrollment target
NCT00245037: Completed Phase 1 study, sponsored by OHSU Knight Cancer Institute.
NCT00245037 is a Phase 1 study that has completed, run by OHSU Knight Cancer Institute. The registered enrollment target is 147 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (145% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00245037, a Phase 1 study, has completed, sponsored by OHSU Knight Cancer Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 147 participants
- Enrollment target
Study Summary
RATIONALE: Giving low doses of chemotherapy, such as fludarabine and busulfan, before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil after the transplant may stop this from happening. PURPOSE: This phase I/II trial is studying the side effects of giving busulfan and fludarabine together with total-body irradiation and to see how well they work in treating patients who are undergoing a donor stem cell transplant for hematologic cancer.
Primary Outcome
Non-hematologic toxicities and adverse experiences ≥ Grade 3 occurrences measured up to day +100 using the NCI Common Toxicity Criteria for Adverse Events v3.0 (CTCAE). Infections and GVHD will be assessed up to 5 years post transplant. The following data represents the number of regimen-related, grade 3 and 4 toxicities that occurred in each category.
Interventions
- DRUG fludarabine phosphate
- DRUG busulfan
- DRUG cyclosporine
- DRUG mycophenolate mofetil
- BIOLOGICAL therapeutic allogeneic lymphocytes
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 147 participants |
| Start Date | 2005-06 |
| Est. Completion | 2015-08 |
| Phase | Phase 1 |
What the finished NCT00245037 record still lists
NCT00245037 is an interventional study that assigns participants to a tested intervention. The registered 147 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (145% higher).
The record links to 0 conditions, and to 5 interventions - of which fludarabine phosphate is the first listed.
NCT00245037 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00245037 about?
NCT00245037 is a clinical study titled "Busulfan, Fludarabine, and Total-Body Irradiation in Treating Patients Who Are Undergoing a Donor Stem Cell Transplant for Hematologic Cancer". RATIONALE: Giving low doses of chemotherapy, such as fludarabine and busulfan, before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's...
What is the current status of trial NCT00245037?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 147 participants. The study started on 2005-06. Estimated completion is 2015-08.
What interventions are being tested in trial NCT00245037?
The interventions under investigation include: fludarabine phosphate (DRUG), busulfan (DRUG), cyclosporine (DRUG), mycophenolate mofetil (DRUG), therapeutic allogeneic lymphocytes (BIOLOGICAL).
Who is sponsoring clinical trial NCT00245037?
This trial is sponsored by OHSU Knight Cancer Institute, which has 211 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00245037's enrollment target sits among peer trials
147 387th of 2000 higher than 1,610 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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