Clinical Trial to Evaluate the Protective Efficacy and Safety of a Therapeutic Vaccine, ASP0113, in CMV-Seropositive Recipients Undergoing Allogeneic, Hematopoietic Cell Transplant(HCT)
- Conditions
- Diseases of the blood and blood -forming organs and certain disorders involving the immune mechanism
- Registration Number
- KCT0000990
- Lead Sponsor
- Astellas Pharm
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 500
1. Subject is a CMV-seropositive HCT recipient
2. Subject is planned to undergo either of the following:
a. Sibling Donor Transplant
b. Unrelated Donor Transplant
3. Subject has one of the following underlying diseases:
a. Acute myeloid leukemia (AML)
b. Acute lymphoblastic leukemia (ALL)
c. Acute undifferentiated leukemia (AUL)
d. Acute biphenotypic leukemia
e. Chronic myelogenous leukemia (CML)
f. Chronic lymphocytic leukemia (CLL).
g. A defined myelodysplastic syndrome(s) (MDS)
h. Primary or secondary myelofibrosis
i. Lymphoma (including Hodgkin's)
l. 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
2. Subject has a modified hematopoietic cell transplant comorbidity index (HCT-CI) score = 4
3. Subject has received a prior HCT and has residual Chronic Graft-versus-host Disease (cGVHD)
4. Subject who is scheduled to have a cord blood transplant or a haploidentical transplant
5. Subject has a platelet count of less than 50,000mm3 within 3days prior to randomization(platelet transfusions are allowed)
6. Subject has aplastic anemia or multiple myeloma
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall mortality and Cytomegalovirus (CMV) End Organ Disease (EOD)
- Secondary Outcome Measures
Name Time Method Time to first protocol-defined cytomegalovirus (CMV) viremia(CMV plasma viral load = 1000 IU/mL, central lab) through one year post transplant;Time to first adjudicated CMV-specific anti-viral therapy(AVT);Time to first CMV-specific AVT for protocol-defined CMV viremia or CMV end organ disease(EOD)