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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

None Provided.

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