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Eligibility
for people ages 18 years and up
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:

Description

Summary

The purpose of the study is 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 subjects 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)

Keywords

Cytomegalovirus (CMV)-Positive Recipients Allogeneic, Hematopoietic Cell Transplant (HCT) ASP0113 Cytomegalovirus (CMV) Hematopoietic Cell Transplant (HCT) Vaccines

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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)

You CAN'T join if...

  • 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

Locations

  • Site US10026
    Stanford, California, 94305, United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Astellas Pharma Global Development, Inc.
ID
NCT01877655
Phase
Phase 3
Study Type
Interventional
Last Updated
May 1, 2017