A Study to Evaluate a Therapeutic Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seropositive Recipients Undergoing Allogeneic, Hematopoietic Cell Transplant (HCT)
Study type: Interventional What is this?
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase: III What is this?
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
- Rochester, Minnesota: 13-002949
NCT ID: NCT01877655
Sponsor Protocol Number: 0113-CL-1004
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.
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. If you need assistance understanding the eligibility criteria, please contact the study team.
See eligibility 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)
- 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 us for help.