for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:
Aaron Logan



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)


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


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


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


  • Site US10035
    San Francisco California 94143 United States
  • Site US10026
    Stanford California 94305 United States

Lead Scientist

  • Aaron Logan
    The phone number listed above is my direct office number. If you prefer to contact the outpatient clinic, please call 415-353-2421. The clinic fax number is 415-353-2467.


in progress, not accepting new patients
Start Date
Completion Date
Astellas Pharma Global Development, Inc.
Phase 3
Study Type
Last Updated