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NCT00045305 · ClinicalTrials.gov registry record · Phase 2
Reduced-Intensity Regimen Before Donor Bone Marrow Transplant in Treating Patients With Myelodysplastic Syndromes
A Phase 2 study, sponsored by Eastern Cooperative Oncology Group.
- Completed
- Registry status
- Phase 2
- Development phase
- 17
- Enrollment target
NCT00045305: Completed Phase 2 study, sponsored by Eastern Cooperative Oncology Group.
NCT00045305 is a Phase 2 study that has completed, run by Eastern Cooperative Oncology Group. The registered enrollment target is 17 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00045305, a Phase 2 study, has completed, sponsored by Eastern Cooperative Oncology Group.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 17 participants
- Enrollment target
Study Summary
RATIONALE: Photopheresis treats the patient's blood with drugs and ultraviolet light outside the body and kills the white blood cells. Giving photopheresis, pentostatin, and radiation therapy before a donor bone marrow or stem cell transplant helps stop 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). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving pentostatin before transplant and cyclosporine or mycophenolate mofetil after transplant may stop this from happening. PURPOSE: This phase II trial is studying how well giving pentostatin together with photopheresis and total-body irradiation work before donor bone marrow transplant in treating patients with myelodysplastic syndromes.
Primary Outcome
Completed response is defined as: Bone marrow evaluation: Repeat bone marrow showing \< 5% myeloblasts with normal maturation of all cell lines, with no evidence for dysplasia (see dysplasia qualifier under peripheral blood evaluation). Peripheral blood evaluation \[absolute values must last at least 2 months\] Hemoglobin \>11 g/dl (untransfused, not on erythropoietin) Neutrophils (1500/mm3 (not on a myeloid growth factor)) Platelets (100,000/mm3 (not on a thrombopoetic agent)) Blasts - 0% No
Interventions
- DRUG Methotrexate
- DRUG Cyclosporine
- DRUG Mycofenolate mofetil
- DRUG Pentostatin
- DRUG Photopheresis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2006-10-24 |
| Est. Completion | 2014-09 |
| Phase | Phase 2 |
What the finished NCT00045305 record still lists
NCT00045305 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 5 interventions - of which Methotrexate is the first listed.
NCT00045305 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00045305 about?
NCT00045305 is a clinical study titled "Reduced-Intensity Regimen Before Donor Bone Marrow Transplant in Treating Patients With Myelodysplastic Syndromes". RATIONALE: Photopheresis treats the patient's blood with drugs and ultraviolet light outside the body and kills the white blood cells. Giving photopheresis, pentostatin, and radiation therapy before a donor bone marrow or stem cell transplant helps stop the patient's immune system from rejecting the...
What is the current status of trial NCT00045305?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 17 participants. The study started on 2006-10-24. Estimated completion is 2014-09.
What interventions are being tested in trial NCT00045305?
The interventions under investigation include: Methotrexate (DRUG), Cyclosporine (DRUG), Mycofenolate mofetil (DRUG), Pentostatin (DRUG), Photopheresis (DRUG).
Who is sponsoring clinical trial NCT00045305?
This trial is sponsored by Eastern Cooperative Oncology Group, which has 141 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00045305's enrollment target sits among peer trials
17 1903rd of 2000 higher than 93 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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