A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Evaluate the Protective Efficacy and Safety of a Therapeutic Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seropositive Recipients Undergoing Allogeneic, Hematopoietic Cell Transplant (HCT)

Location:

Rochester, Minn.

Trial status:

Open for Enrollment

Why is this study being done?

The study will be divided into two parts. Part 1 of the study will include the first 100 subjects who are randomized. The purpose of Part 1 is to collect efficacy results to evaluate treatment effect on the primary endpoint and other efficacy endpoints to potentially modify the primary endpoint for being specified for Part 2 of the study. Part 2 will include the subsequent 400 subjects to evaluate the vaccine efficacy on the incidence of the primary endpoint through one year post-transplant.

Who is eligible to participate?

Inclusion Criteria: - Subject is a CMV-seropositive HCT recipient - Subject is planned to undergo either of the following: - Sibling Donor Transplant - Unrelated Donor Transplant - Subject 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: - Subject has active CMV disease or infection or has received treatment for active CMV disease or infection within 3 months (90 days) prior to transplant - Subject has a modified hematopoietic cell transplant comorbidity index (HCT-CI) score ≥ 4 - Subject has received a prior HCT and has residual Chronic Graft-versus-host Disease (cGVHD) - Subject who is scheduled to have a cord blood transplant or a haploidentical transplant - Subject has a platelet count of less than 50,000 mm3 within 3 days prior to randomization (platelet transfusions are allowed) - Subject has aplastic anemia or multiple myeloma

Last updated:

6/19/2014

NCT ID:

NCT01877655

IRB Number:

13-002949