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NCT00134004 · ClinicalTrials.gov registry record · Phase 2
Fludarabine, Cyclophosphamide, and Total-Body Irradiation in Treating Patients Who Are Undergoing a Donor Bone Marrow Transplant for Hematologic Cancer
A Phase 2 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Completed
- Registry status
- Phase 2
- Development phase
- 210
- Enrollment target
NCT00134004: Completed Phase 2 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
NCT00134004 is a Phase 2 study that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 210 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (58% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00134004, a Phase 2 study, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 210 participants
- Enrollment target
Study Summary
RATIONALE: Giving low doses of chemotherapy, such as fludarabine and cyclophosphamide, and radiation therapy before a donor bone marrow transplant helps stop the growth of cancer cells. Giving chemotherapy or radiation therapy before or after transplant also stops the patient's immune system from rejecting the donor's bone marrow stem cells. The donated stem cells may replace the patient's immune system 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 and mycophenolate mofetil after the transplant may stop this from happening. PURPOSE: This phase II trial is studying how well giving fludarabine and cyclophosphamide together with total-body irradiation works in treating patients who are undergoing a donor bone marrow transplant for hematologic cancer.
Primary Outcome
Percentage of participants who die for any reason other than recurrence of disease.
Interventions
- DRUG cyclophosphamide
- DRUG fludarabine phosphate
- DRUG tacrolimus
- PROCEDURE allogeneic bone marrow transplantation
- DRUG mycophenolate mofetil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 210 participants |
| Start Date | 2004-10 |
| Est. Completion | 2015-01 |
| Phase | Phase 2 |
What the finished NCT00134004 record still lists
NCT00134004 is an interventional study that assigns participants to a tested intervention. The registered 210 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (58% higher).
The record links to 0 conditions, and to 5 interventions - of which cyclophosphamide is the first listed.
NCT00134004 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00134004 about?
NCT00134004 is a clinical study titled "Fludarabine, Cyclophosphamide, and Total-Body Irradiation in Treating Patients Who Are Undergoing a Donor Bone Marrow Transplant for Hematologic Cancer". RATIONALE: Giving low doses of chemotherapy, such as fludarabine and cyclophosphamide, and radiation therapy before a donor bone marrow transplant helps stop the growth of cancer cells. Giving chemotherapy or radiation therapy before or after transplant also stops the patient's immune system from re...
What is the current status of trial NCT00134004?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 210 participants. The study started on 2004-10. Estimated completion is 2015-01.
What interventions are being tested in trial NCT00134004?
The interventions under investigation include: cyclophosphamide (DRUG), fludarabine phosphate (DRUG), tacrolimus (DRUG), allogeneic bone marrow transplantation (PROCEDURE), mycophenolate mofetil (DRUG).
Who is sponsoring clinical trial NCT00134004?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00134004's enrollment target sits among peer trials
210 290th of 2000 higher than 1,707 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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