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



Status:Active, not recruiting
Healthy:No
Age Range:18 - Any
Updated:3/8/2019
Start Date:September 11, 2013
End Date:November 2020

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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)

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.

Participants will be followed for 5.5 years post-transplant for long-term safety via an
annual telephone contact.

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
We found this trial at
31
sites
Atlanta, Georgia 30322
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Baltimore, Maryland 21205
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Baltimore, Maryland 21205
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Birmingham, Alabama 35294
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Birmingham, AL
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46 Joy Street
Boston, Massachusetts 02114
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Boston, MA
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Chapel Hill, North Carolina 27514
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Chapel Hill, NC
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Chicago, Illinois 60612
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Chicago, IL
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Chicago, Illinois 60612
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Chicago, Illinois 60612
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Dallas, Texas 75246
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Hackensack, New Jersey 07601
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Herston, Queensland 4101
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Herston,
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Houston, Texas 77030
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Houston, TX
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Houston, Texas 77030
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Indianapolis, Indiana 46237
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Indianapolis, IN
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Louisville, Kentucky 40202
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Milwaukee, Wisconsin 53226
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Milwaukee, WI
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Nashville, Tennessee 37232
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New York, New York 10032
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Richmond, Virginia 23298
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Richmond, VA
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Rochester, Minnesota 55905
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Rochester, MN
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Rochester, New York 14642
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Saint Louis, Missouri 63110
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Salt Lake City, Utah 84143
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San Francisco, California 94143
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Seattle, Washington 98101
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Seattle, Washington 98101
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Stanford, California 94305
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Tampa, Florida 33612
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Tucson, Arizona 85719
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Westwood, Kansas 66205
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Westwood, KS
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