Status:
COMPLETED
A Study to Evaluate a Therapeutic Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seropositive Recipients Undergoing Allogeneic, Hematopoietic Cell Transplant (HCT)
Lead Sponsor:
Astellas Pharma Global Development, Inc.
Conditions:
Cytomegalovirus (CMV)-Positive Recipients
Allogeneic, Hematopoietic Cell Transplant (HCT)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 p...
Detailed Description
Participants will be followed for 5.5 years post-transplant for long-term safety via an annual telephone contact.
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
September 11 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2022
Estimated Enrollment :
514 Patients enrolled
Trial Details
Trial ID
NCT01877655
Start Date
September 11 2013
End Date
March 1 2022
Last Update
October 24 2024
Active Locations (83)
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1
Site US10028
Birmingham, Alabama, United States, 35294
2
Site US10044
Tucson, Arizona, United States, 85724
3
Site US10035
San Francisco, California, United States, 94143
4
Site US10026
Stanford, California, United States, 94305