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NCT02396134 · ClinicalTrials.gov registry record · Phase 2
Vaccine Therapy in Reducing the Frequency of Cytomegalovirus Events in Patients With Hematologic Malignancies Undergoing Donor Stem Cell Transplant
A Phase 2 study, sponsored by City of Hope Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 61
- Enrollment target
NCT02396134: Completed Phase 2 study, sponsored by City of Hope Medical Center.
NCT02396134 is a Phase 2 study that has completed, run by City of Hope Medical Center. The registered enrollment target is 61 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (54% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02396134, a Phase 2 study, has completed, sponsored by City of Hope Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 61 participants
- Enrollment target
Study Summary
This randomized phase II trial studies how well vaccine therapy works in reducing the frequency of cytomegalovirus severe infections (events) in patients with hematologic malignancies undergoing donor stem cell transplant. Vaccines made from a peptide may help the body build an effective immune response and may reduce cytomegalovirus events after donor stem cell transplant.
Primary Outcome
The primary endpoint was CMV event. A CMV event encompasses detection of CMV by either qPCR (termed "reactivation": DNAemia at ≥500 gc/ml = 1250iu/ml) or by tissue histology (end-organ disease). The cumulative incidence was calculated as competing risks using the method of Gooley with death viewed as a competing risk.
Interventions
- OTHER Placebo
- OTHER Laboratory Biomarker Analysis
- BIOLOGICAL CMVpp65-A*0201 peptide vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2015-05-21 |
| Est. Completion | 2024-09-19 |
| Phase | Phase 2 |
What the finished NCT02396134 record still lists
NCT02396134 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (54% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02396134 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02396134 about?
NCT02396134 is a clinical study titled "Vaccine Therapy in Reducing the Frequency of Cytomegalovirus Events in Patients With Hematologic Malignancies Undergoing Donor Stem Cell Transplant". This randomized phase II trial studies how well vaccine therapy works in reducing the frequency of cytomegalovirus severe infections (events) in patients with hematologic malignancies undergoing donor stem cell transplant. Vaccines made from a peptide may help the body build an effective immune resp...
What is the current status of trial NCT02396134?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 61 participants. The study started on 2015-05-21. Estimated completion is 2024-09-19.
What interventions are being tested in trial NCT02396134?
The interventions under investigation include: Placebo (OTHER), Laboratory Biomarker Analysis (OTHER), CMVpp65-A*0201 peptide vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT02396134?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02396134's enrollment target sits among peer trials
61 1026th of 2000 higher than 974 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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