Summary

for people ages 18 years and up (full criteria)
at UCSF
study started
estimated completion

Description

Summary

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)

Details

Participants will be followed for 5.5 years post-transplant for long-term safety via an annual telephone contact.

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

  • 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)

You CAN'T join if...

  • 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

Locations

  • Site US10035
    San Francisco California 94143 United States
  • 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