A Study to Evaluate a Therapeutic Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seropositive Recipients Undergoing Allogeneic, Hematopoietic Cell Transplant (HCT)

• Status: Active, not recruiting
• Trial end date: 2022-03-31
• Target enrollment: 0
• Participant gender: All

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 post-transplant. Safety of ASP0113 in participants undergoing allogeneic HCT will also be evaluated.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Global Development, Inc.
• Collaborator: Vical
• Treatments: Vaccines

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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