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NCT01427881 · ClinicalTrials.gov registry record · Phase 2
Cyclophosphamide for Prevention of Graft-Versus-Host Disease After Allogeneic Peripheral Blood Stem Cell Transplantation in Patients With Hematological Malignancies
A Phase 2 study, sponsored by Fred Hutchinson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 43
- Enrollment target
NCT01427881: Completed Phase 2 study, sponsored by Fred Hutchinson Cancer Center.
NCT01427881 is a Phase 2 study that has completed, run by Fred Hutchinson Cancer Center. The registered enrollment target is 43 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01427881, a Phase 2 study, has completed, sponsored by Fred Hutchinson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 43 participants
- Enrollment target
Study Summary
This phase II trial studies how well cyclophosphamide works in preventing chronic graft-versus-host disease after allogeneic peripheral blood stem cell transplant in patients with hematological malignancies. Giving chemotherapy and total-body irradiation before transplantation helps stop the growth of cancer cells and prevents the patient's immune system from rejecting the donor's stem cells. Healthy stem cells from a donor that are infused into the patient help the patient's bone marrow make blood cells; red blood cells, white blood cells, and platelets. Sometimes, however, the transplanted donor cells can cause an immune response against the body's normal cells, which is called graft-versus-host disease (GVHD). Giving cyclophosphamide after transplant may prevent this from happening or may make chronic GVHD less severe.
Primary Outcome
Chronic GVHD will be defined by National Institutes of Health (NIH) criteria and requiring systemic treatment. A reduction in the cumulative incidence of GVHD from \~35% to \~15% at 1 year would represent a reasonable goal. A sample size of 42 patients provides 90% power to observe such a difference with one-side 5% type-1 error.
Interventions
- DRUG cyclophosphamide
- DRUG fludarabine phosphate
- PROCEDURE peripheral blood stem cell transplantation
- DRUG cyclosporine
- RADIATION total-body irradiation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2011-09 |
| Est. Completion | 2015-07 |
| Phase | Phase 2 |
What the finished NCT01427881 record still lists
NCT01427881 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 5 interventions - of which cyclophosphamide is the first listed.
NCT01427881 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01427881 about?
NCT01427881 is a clinical study titled "Cyclophosphamide for Prevention of Graft-Versus-Host Disease After Allogeneic Peripheral Blood Stem Cell Transplantation in Patients With Hematological Malignancies". This phase II trial studies how well cyclophosphamide works in preventing chronic graft-versus-host disease after allogeneic peripheral blood stem cell transplant in patients with hematological malignancies. Giving chemotherapy and total-body irradiation before transplantation helps stop the growth ...
What is the current status of trial NCT01427881?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 43 participants. The study started on 2011-09. Estimated completion is 2015-07.
What interventions are being tested in trial NCT01427881?
The interventions under investigation include: cyclophosphamide (DRUG), fludarabine phosphate (DRUG), peripheral blood stem cell transplantation (PROCEDURE), cyclosporine (DRUG), total-body irradiation (RADIATION).
Who is sponsoring clinical trial NCT01427881?
This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01427881's enrollment target sits among peer trials
43 1332nd of 2000 higher than 662 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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