Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 1 study that has completed, run by OHSU Knight Cancer Institute. The registered enrollment target is 147 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00245037
The ClinicalTrials.gov registry entry for NCT00245037 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 147 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is OHSU Knight Cancer Institute, which has 211 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which fludarabine phosphate is the first listed.
NCT00245037 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.