A Study to Evaluate a Therapeutic Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seropositive Recipients Undergoing Allogeneic, Hematopoietic Cell Transplant (HCT)
Completed · Phase 3 · Has a placebo group
Conditions studied: Cytomegalovirus (CMV)-Positive Recipients, Allogeneic, Hematopoietic Cell Transplant (HCT)
In brief
The purpose of the study was to evaluate the efficacy of ASP0113 compared with placebo as measured by a primary composite endpoint of overall mortality and CMV end organ disease (EOD) through 1 year post-transplant. Safety of ASP0113 in participants undergoing allogeneic HCT will also be evaluated.
Key facts
- Study ID
- NCT01877655
- Run by
- Astellas Pharma Global Development, Inc.
- People needed
- 514
- Starts
- 2013-09-11
- Expected to finish
- 2022-03-01
- Last updated by the study team
- 2024-10-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Participant is a CMV-seropositive HCT recipient
- Participant is planned to undergo either of the following:
- Sibling Donor Transplant
- Unrelated Donor Transplant
- Participant has one of the following underlying diseases:
- Acute myeloid leukemia (AML)
- Acute lymphoblastic leukemia (ALL)
- Acute undifferentiated leukemia (AUL)
- Acute biphenotypic leukemia
- Chronic myelogenous leukemia (CML)
- Chronic lymphocytic leukemia (CLL).
- A defined myelodysplastic syndrome(s) (MDS)
- Primary or secondary myelofibrosis
- Lymphoma (including Hodgkin's)
You may not qualify if…
- Participant has active CMV disease or infection or has received treatment for active CMV disease or infection within 3 months (90 days) prior to transplant
- Participant has a modified hematopoietic cell transplant comorbidity index (HCT-CI) score ≥ 4
- Participant has received a prior HCT and has residual Chronic Graft-versus-host Disease (cGVHD)
- Participant who is scheduled to have a cord blood transplant or a haploidentical transplant
- Participant has a platelet count of less than 50,000 mm3 within 3 days prior to randomization (platelet transfusions are allowed)
- Participant has aplastic anemia or multiple myeloma
Where it is running
- Site US10044 — Tucson, Arizona, United States
- Site US10035 — San Francisco, California, United States
- Site US10026 — Stanford, California, United States
- Site US10030 — Tampa, Florida, United States
- Site US10012 — Atlanta, Georgia, United States
- Site US10013 — Chicago, Illinois, United States
- Site US10007 — Indianapolis, Indiana, United States
- Site US10020 — Westwood, Kansas, United States
- Site US10010 — Louisville, Kentucky, United States
- Site US10043 — Baltimore, Maryland, United States
- Site US10011 — Baltimore, Maryland, United States
- Site US10021 — Boston, Massachusetts, United States
- Site US10036 — Rochester, Minnesota, United States
- Site US10042 — St Louis, Missouri, United States
- Site US10023 — Hackensack, New Jersey, United States
- Site US10047 — New York, New York, United States
- Site US10027 — Rochester, New York, United States
- Site US10025 — Chapel Hill, North Carolina, United States
- Site US10016 — Nashville, Tennessee, United States
- Site US10002 — Dallas, Texas, United States
- Site US10045 — Houston, Texas, United States
- Site US10046 — Salt Lake City, Utah, United States
- Site US10031 — Richmond, Virginia, United States
- Site US10039 — Seattle, Washington, United States
- Site US10028 — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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