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Clinical Trial VICCBMT1335

Title

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Evaluate the Protective Efficacy and Safety of a Therapeutic Vaccine, ASP01113, in Cytomegalovirus (CMV)-Seropositive Recipients Undergoing Allogeneic, Hematopoietic Cell Transplant (HCT)

Principal Investigator(s)

Madan Jagasia

Details

  • Protocol No. VICCBMT1335
  • Open Date: 02/18/2014
  • Staging: Phase III
  • Age Group: Adults
  • Scope: International
  • Objective: To assess the adequacy of the primary endpoint, overall mortality, through one year post-transplant to evaluate the vaccine efficacy of ASP0113 in HCT recipients, and, if necessary, select additional components for an alternative primary composite endpoint.
  • Disease Sites: Leukemia; Lymphoma
  • Therapies: Supportive Care
  • Drugs: ASP0113
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT01877655
  • Secondary Protocol No: 0113-CL-1004

Description

The purpose of the research study is to determine if a vaccine, ASP0113, prevents or reduces cytomegalovirus (CMV) infections and complications resulting from the infection and how safe ASP0113 is in patients who receive a hematopoietic cell transplant. ASP0113 is an investigational vaccine. An investigational vaccine means that it is being tested and is not approved by regulatory authorities. This vaccine is made from manufactured genes that could give protection from the CMV virus.

Eligibility

Ages Eligible for Study:18 Years and older
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No

Criteria

Inclusion Criteria:
• Subject is a CMV-seropositive HCT recipient
• Subject is planned to undergo either of the following:
• Sibling Donor Transplant
• Unrelated Donor Transplant
• Subject 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:
• Subject has active CMV disease or infection or has received treatment for active CMV disease or infection within 3 months (90 days) prior to transplant
• Subject has a modified hematopoietic cell transplant comorbidity index (HCT-CI) score ≥ 4
• Subject has received a prior HCT and has residual Chronic Graft-versus-host Disease (cGVHD)
• Subject who is scheduled to have a cord blood transplant or a haploidentical transplant
• Subject has a platelet count of less than 50,000 mm3 within 3 days prior to randomization (platelet transfusions are allowed)
• Subject has aplastic anemia or multiple myeloma