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

Trial ID or NCT#

NCT01877655

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official Title

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)

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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
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Investigator(s)

Wes (Janice) Brown
Wes (Janice) Brown
Blood and marrow transplant specialist, Blood and marrow transplant specialist, Infectious disease doctor
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

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Contact

Physician Referrals
650-723-0822

View on ClinicalTrials.gov