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

Not Recruiting

Trial ID: NCT01877655

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)

Stanford Investigator(s)

Lori Muffly
Lori Muffly

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Eligibility

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

Intervention(s):

biological: ASP0113

drug: Placebo

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Physician Referrals
650-723-0822

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