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NCT02458235 · ClinicalTrials.gov registry record · Phase 2
Donor Lymphocyte Infusion With Azacitidine to Prevent Hematologic Malignancy Relapse After Stem Cell Transplantation
A Phase 2 study, sponsored by University of California, San Francisco.
- Completed
- Registry status
- Phase 2
- Development phase
- 17
- Enrollment target
NCT02458235: Completed Phase 2 study, sponsored by University of California, San Francisco.
NCT02458235 is a Phase 2 study that has completed, run by University of California, San Francisco. 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
NCT02458235, a Phase 2 study, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 17 participants
- Enrollment target
Study Summary
The goal of this study is to determine whether post-transplant consolidation with azacitidine combined with donor lymphocyte infusion (DLI) is a safe and effective approach for the prevention of relapse in pediatric and young adult patients with hematologic malignancies who have undergone hematopoietic stem cell transplantation (HSCT).
Primary Outcome
Relapse rate will be estimated using a percentage of participants who relapsed. It is assumed that the rate of relapse in pediatric acute leukemia post-transplant would be 40%, azacitidine +/- Donor Lymphocyte Infusion (DLI) would reduce the 2-year relapse rate by approximately 40% to a rate of 25%.
Interventions
- DRUG azacitidine
- BIOLOGICAL donor lymphocyte infusion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2015-06-02 |
| Est. Completion | 2019-03-15 |
| Phase | Phase 2 |
What the finished NCT02458235 record still lists
NCT02458235 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 2 interventions - of which azacitidine is the first listed.
NCT02458235 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02458235 about?
NCT02458235 is a clinical study titled "Donor Lymphocyte Infusion With Azacitidine to Prevent Hematologic Malignancy Relapse After Stem Cell Transplantation". The goal of this study is to determine whether post-transplant consolidation with azacitidine combined with donor lymphocyte infusion (DLI) is a safe and effective approach for the prevention of relapse in pediatric and young adult patients with hematologic malignancies who have undergone hematopoie...
What is the current status of trial NCT02458235?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 17 participants. The study started on 2015-06-02. Estimated completion is 2019-03-15.
What interventions are being tested in trial NCT02458235?
The interventions under investigation include: azacitidine (DRUG), donor lymphocyte infusion (BIOLOGICAL).
Who is sponsoring clinical trial NCT02458235?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02458235'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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