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NCT01588015 · ClinicalTrials.gov registry record · Phase 1
Vaccine Therapy in Preventing Cytomegalovirus Infection in Patients With Hematological Malignancies Undergoing Donor Stem Cell Transplant
A Phase 1 study, sponsored by City of Hope Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
NCT01588015: Completed Phase 1 study, sponsored by City of Hope Medical Center.
NCT01588015 is a Phase 1 study that has completed, run by City of Hope Medical Center. The registered enrollment target is 36 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01588015, a Phase 1 study, has completed, sponsored by City of Hope Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
Study Summary
This randomized phase I trial studies the side effects of vaccine therapy in preventing cytomegalovirus (CMV) infection in patients with hematological malignancies undergoing donor stem cell transplant. Vaccines made from a tetanus-CMV peptide or antigen may help the body build an effective immune response and prevent or delay the recurrence of CMV infection in patients undergoing donor stem cell transplant for hematological malignancies.
Primary Outcome
GVHD, local and systemic reactogenicity, and toxicity related to the vaccine formulation will be evaluated by the study principal investigator (PI), conferring with the treating physician. AEs will be summarized for each treatment group by type (MedDRA codes within organ systems), grade, and attribution.
Interventions
- OTHER laboratory biomarker analysis
- BIOLOGICAL tetanus-CMV fusion peptide vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2012-10-29 |
| Est. Completion | 2024-02-02 |
| Phase | Phase 1 |
What the finished NCT01588015 record still lists
NCT01588015 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 2 interventions - of which laboratory biomarker analysis is the first listed.
NCT01588015 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01588015 about?
NCT01588015 is a clinical study titled "Vaccine Therapy in Preventing Cytomegalovirus Infection in Patients With Hematological Malignancies Undergoing Donor Stem Cell Transplant". This randomized phase I trial studies the side effects of vaccine therapy in preventing cytomegalovirus (CMV) infection in patients with hematological malignancies undergoing donor stem cell transplant. Vaccines made from a tetanus-CMV peptide or antigen may help the body build an effective immune r...
What is the current status of trial NCT01588015?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2012-10-29. Estimated completion is 2024-02-02.
What interventions are being tested in trial NCT01588015?
The interventions under investigation include: laboratory biomarker analysis (OTHER), tetanus-CMV fusion peptide vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT01588015?
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 NCT01588015's enrollment target sits among peer trials
36 1210th of 2000 higher than 743 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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