Trial Search Results

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

Immunocompromised patients, including patients undergoing hematopoietic cell transplant, are particularly vulnerable to Cytomegalovirus (CMV) infection and reactivation. CMV infection is a risk factor for CMV end-organ disease, as well as a risk factor for aGVHD, cGVHD,bacterial and fungal infections, and increased mortality. ASP0113 is a DNA vaccine designed to prevent CMV infection in immunocompromised hosts. A Phase 1 and Phase 2 study suggest that the vaccine is safe, immunogenic and effective in preventing CMV viremia in CMV seropositive subjects undergoing hematopoietic transplant. This Phase 3 pivotal, randomized, double-blind, placebo-controlled trial is designed to assess the incidence of mortality through one year posttransplantin the ASP0113 group as compared to the placebo group.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Astellas Pharma Global Development, Inc.

Stanford Investigator(s):

Intervention(s):

  • Biological: ASP0113
  • Drug: Placebo

Phase:

Phase 3

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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Physician Referrals
650-723-0822
Not Recruiting