A Study to Evaluate a Therapeutic Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seropositive Recipients Undergoing Allogeneic, Hematopoietic Cell Transplant (HCT)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Astellas Pharma Global Development, Inc.
Participants will be followed for 5.5 years post-transplant for long-term safety via an annual telephone contact.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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 may not be 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
Clareo Health | A Study to Evaluate a Therapeutic Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seropositive Recipients Undergoing Allogeneic, Hematopoietic Cell Transplant (HCT)
