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NCT04060277 · ClinicalTrials.gov registry record · Phase 2
Triplex Vaccine in Preventing CMV Infection in Patients Undergoing Hematopoietic Stem Cell Transplantation
A Phase 2 study of Acute Myeloid Leukemia and Chronic Lymphocytic Leukemia, sponsored by City of Hope Medical Center.
- Active
- Registry status
- Phase 2
- Development phase
- 7
- Enrollment target
- 1
- Study location
NCT04060277: Active Phase 2 study of Acute Myeloid Leukemia and Chronic Lymphocytic Leukemia, sponsored by City of Hope Medical Center.
NCT04060277 is a Phase 2 study of Acute Myeloid Leukemia and Chronic Lymphocytic Leukemia that is active but no longer recruiting, run by City of Hope Medical Center. The registered enrollment target is 7 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04060277, a Phase 2 study of Acute Myeloid Leukemia and Chronic Lymphocytic Leukemia, is active but no longer recruiting, sponsored by City of Hope Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 7 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial studies how well Triplex vaccine works in preventing cytomegalovirus (CMV) infection in patients undergoing a hematopoietic stem cell transplantation. CMV is a virus that may be carried for life and does not cause illness in most healthy individuals. However, in people whose immune systems are lowered (such as those undergoing stem cell transplantation), CMV can reproduce and cause disease and even death. The Triplex vaccine is made up of 3 small pieces of CMV deoxyribonucleic acid (DNA) (the chemical form of genes) placed into a weakened virus called modified vaccinia Ankara (MVA) that may help produce immunity (the ability to recognize and respond to an infection) and reduce the risk of developing complications related to CMV infection.
Primary Outcome
Cytomegalovirus (CMV) event was defined as CMV reactivation (DNAemia \>625 IU/ml by qPCR), viremia treated by antivirals, or detection of CMV by tissue histology (end-organ disease), from Day 100 post-HCT to Day 180 post-HCT. Trial participants were quantitatively monitored for viremia, by plasma qPCR test once every two weeks (+/- 5d) from Day 100 to Day 180. CMV monitoring used standard qPCR clinical laboratory methods to evaluate CMV viral load and possible vaccine failure.
Conditions Studied
Interventions
- DRUG Letermovir
- BIOLOGICAL Multi-peptide CMV-Modified Vaccinia Ankara Vaccine
- OTHER Placebo Administration
Study Locations (1)
California
- City of Hope Medical Center - Duarte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2019-11-27 |
| Est. Completion | 2030-04-07 |
| Phase | Phase 2 |
What the registry record for NCT04060277 still lists
NCT04060277 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (94% lower).
The record links to 10 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 3 interventions - of which Letermovir is the first listed.
NCT04060277 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04060277 about?
NCT04060277 is a clinical study titled "Triplex Vaccine in Preventing CMV Infection in Patients Undergoing Hematopoietic Stem Cell Transplantation". This phase II trial studies how well Triplex vaccine works in preventing cytomegalovirus (CMV) infection in patients undergoing a hematopoietic stem cell transplantation. CMV is a virus that may be carried for life and does not cause illness in most healthy individuals. However, in people whose immu...
What is the current status of trial NCT04060277?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 7 participants. The study started on 2019-11-27. Estimated completion is 2030-04-07.
What conditions does trial NCT04060277 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Chronic Lymphocytic Leukemia, Myelodysplastic Syndrome, Acute Lymphoblastic Leukemia, Hematopoietic and Lymphoid Cell Neoplasm.
What interventions are being tested in trial NCT04060277?
The interventions under investigation include: Letermovir (DRUG), Multi-peptide CMV-Modified Vaccinia Ankara Vaccine (BIOLOGICAL), Placebo Administration (OTHER).
Who is sponsoring clinical trial NCT04060277?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04060277 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04060277's enrollment target sits among peer trials
7 299th of 306 higher than 5 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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