A Study to Evaluate a Therapeutic Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seropositive Recipients Undergoing Allogeneic, Hematopoietic Cell Transplant (HCT)

Overview

About this study

The purpose of the study is to determine if overall mortality is affected one year after a hematopoietic stem cell transplant (HCT) in patients given a vaccine to prevent cytomegalovirus (CMV). Safety of ASP0113 in subjects undergoing allogeneic HCT will also be evaluated.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status
Rochester, Minn. Mayo Clinic principal investigator William Hogan, M.B., B.Ch.	Closed for enrollment

Mayo Clinic Location

Status

Rochester, Minn.

Mayo Clinic principal investigator

William Hogan, M.B., B.Ch.

Closed for enrollment

More information

Publications

Publications are currently not available

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