A Study to Evaluate a Therapeutic Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seropositive Recipients Undergoing Allogeneic, Hematopoietic Cell Transplant (HCT) (HELIOS)
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ClinicalTrials.gov Identifier: NCT01877655
Recruitment Status :
Active, not recruiting
First Posted : June 14, 2013
Last Update Posted : March 29, 2018
Astellas Pharma Global Development, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )
The purpose of the study is 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 subjects undergoing allogeneic HCT will also be evaluated.
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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)
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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)
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)