This trial is active, not recruiting.

Conditions cytomegalovirus (cmv)-positive recipients, allogeneic, hematopoietic cell transplant (hct)
Treatments asp0113, placebo
Phase phase 3
Sponsor Astellas Pharma Global Development, Inc.
Collaborator Vical
Start date July 2013
End date September 2017
Trial size 516 participants
Trial identifier NCT01877655, 0113-CL-1004, 2013-000903-18


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.

United States Alabama, Arizona, California, Florida, Georgia, Illinois, Maryland, Massachusetts, New York, North Dakota, Tennessee, and Washington
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
ASP0113 arm
intramuscular injection
(Placebo Comparator)
Placebo arm
intramuscular injection

Primary Outcomes

Composite of overall mortality and cytomegalovirus (CMV) End Organ Disease (EOD) through one year post-transplant
time frame: One year post-transplant

Secondary Outcomes

Time to first protocol-defined CMV viremia
time frame: One year post transplant
Time to first adjudicated CMV-specific anti-viral therapy (AVT)
time frame: One year post-transplant
Time to first CMV-specific AVT for protocol-defined CMV viremia or CMV EOD
time frame: One year post-transplant

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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)
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Astellas Pharma Inc.