©2025 Stanford Medicine
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
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