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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)
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