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NCT06059391 · ClinicalTrials.gov registry record · Phase 2
CMV-MVA Triplex Vaccination in HLA-Matched Related Stem Cell Donors for the Prevention of CMV Infection in Patients Undergoing Hematopoietic Stem Cell Transplant
A Phase 2 study of Acute Myeloid Leukemia and Chronic Lymphocytic Leukemia, sponsored by City of Hope Medical Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 216
- Enrollment target
- 3
- Study locations
NCT06059391: Recruiting Phase 2 study of Acute Myeloid Leukemia and Chronic Lymphocytic Leukemia, sponsored by City of Hope Medical Center.
NCT06059391 is a Phase 2 study of Acute Myeloid Leukemia and Chronic Lymphocytic Leukemia that is actively recruiting participants, run by City of Hope Medical Center. The registered enrollment target is 216 participants, above the 115-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (88% higher). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06059391, a Phase 2 study of Acute Myeloid Leukemia and Chronic Lymphocytic Leukemia, is actively recruiting participants, sponsored by City of Hope Medical Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 216 participants
- Enrollment target
- 3
- Study locations
Study Summary
This phase II clinical trial tests how well the cytomegalovirus-modified vaccinica Ankara (CMV-MVA) Triplex vaccine given to human leukocyte antigens (HLA) matched related stem cell donors works to prevent cytomegalovirus (CMV) infection in patients undergoing hematopoietic stem cell transplant. The CMV-MVA Triplex vaccine works by causing an immune response in the donors body to the CMV virus, creating immunity to it. The donor then passes that immunity on to the patient upon receiving the stem cell transplant. Giving the CMV-MVA triplex vaccine to donors may help prevent CMV infection of patients undergoing stem cell transplantation.
Primary Outcome
A stratified Cox regression analysis of time to CMV disease or positron emission tomography (PET) following CMV reactivation prior to Day 180 post-HCT will be performed. The estimated hazard ratio and its 95% confidence interval will be calculated. Secondary analyses will include the Fine-Gray model for competing risk.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Allogeneic Hematopoietic Stem Cell Transplantation
- BIOLOGICAL Multi-peptide CMV-Modified Vaccinia Ankara Vaccine
- DRUG Granulocyte Colony-Stimulating Factor
- DRUG Hematopoietic Cell Transplantation Conditioning Regimen
Study Locations (3)
California
- City of Hope Medical Center - Duarte
Georgia
- Northside Hospital - Atlanta
Massachusetts
- DFCI/BWH Brigham and Women's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 216 participants |
| Start Date | 2024-07-12 |
| Est. Completion | 2029-01-01 |
| Phase | Phase 2 |
What NCT06059391 shows while recruiting
NCT06059391 is an interventional study that assigns participants to a tested intervention. The registered 216 participants enrollment target is mid-sized for trials with a published cap, above the 115-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (88% higher).
The record links to 10 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT06059391 reports a single indexed study location in California, Georgia, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT06059391 about?
NCT06059391 is a clinical study titled "CMV-MVA Triplex Vaccination in HLA-Matched Related Stem Cell Donors for the Prevention of CMV Infection in Patients Undergoing Hematopoietic Stem Cell Transplant". This phase II clinical trial tests how well the cytomegalovirus-modified vaccinica Ankara (CMV-MVA) Triplex vaccine given to human leukocyte antigens (HLA) matched related stem cell donors works to prevent cytomegalovirus (CMV) infection in patients undergoing hematopoietic stem cell transplant. The...
What is the current status of trial NCT06059391?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 216 participants. The study started on 2024-07-12. Estimated completion is 2029-01-01.
What conditions does trial NCT06059391 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Chronic Lymphocytic Leukemia, Myelodysplastic Syndrome, Acute Lymphoblastic Leukemia, Non-Hodgkin Lymphoma.
What interventions are being tested in trial NCT06059391?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Allogeneic Hematopoietic Stem Cell Transplantation (PROCEDURE), Multi-peptide CMV-Modified Vaccinia Ankara Vaccine (BIOLOGICAL), Granulocyte Colony-Stimulating Factor (DRUG), Hematopoietic Cell Transplantation Conditioning Regimen (DRUG).
Who is sponsoring clinical trial NCT06059391?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06059391 being conducted?
This trial has 3 study locations across California, Georgia, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06059391's enrollment target sits among peer trials
216 41st of 306 higher than 266 of 306 other Acute Myeloid Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Myeloid Leukemia 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.
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