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NCT02248597 · ClinicalTrials.gov registry record · Phase 2
Donor Stem Cell Transplant Followed by Cyclophosphamide in Treating Patients With Hematological Diseases
A Phase 2 study, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 27
- Enrollment target
NCT02248597: Completed Phase 2 study, sponsored by Wake Forest University Health Sciences.
NCT02248597 is a Phase 2 study that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 27 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02248597, a Phase 2 study, has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 27 participants
- Enrollment target
Study Summary
This pilot clinical trial studies donor stem cell transplant followed by cyclophosphamide in treating patients with hematological diseases. Giving chemotherapy before a donor stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells (called graft-versus-host disease). Giving cyclophosphamide after the transplant may stop this from happening.
Primary Outcome
The percentage of patients who experience death or disease relapse by one year will be calculated and a corresponding 95% confidence interval will be constructed using the normal approximation for binomial proportions. The survival function will be estimated and plotted using the method of Kaplan and Meier.
Interventions
- DRUG cyclophosphamide
- DRUG fludarabine phosphate
- DRUG tacrolimus
- PROCEDURE allogeneic hematopoietic stem cell transplantation
- DRUG busulfan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2015-02-25 |
| Est. Completion | 2023-01-18 |
| Phase | Phase 2 |
What the finished NCT02248597 record still lists
NCT02248597 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 5 interventions - of which cyclophosphamide is the first listed.
NCT02248597 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02248597 about?
NCT02248597 is a clinical study titled "Donor Stem Cell Transplant Followed by Cyclophosphamide in Treating Patients With Hematological Diseases". This pilot clinical trial studies donor stem cell transplant followed by cyclophosphamide in treating patients with hematological diseases. Giving chemotherapy before a donor stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and...
What is the current status of trial NCT02248597?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 27 participants. The study started on 2015-02-25. Estimated completion is 2023-01-18.
What interventions are being tested in trial NCT02248597?
The interventions under investigation include: cyclophosphamide (DRUG), fludarabine phosphate (DRUG), tacrolimus (DRUG), allogeneic hematopoietic stem cell transplantation (PROCEDURE), busulfan (DRUG).
Who is sponsoring clinical trial NCT02248597?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02248597's enrollment target sits among peer trials
27 1697th of 2000 higher than 293 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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