Clinical Trial to Evaluate the Protective Efficacy and Safety of a Therapeutic Vaccine, ASP0113, in CMV-Seropositive Recipients Undergoing Allogeneic, Hematopoietic Cell Transplant(HCT)

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Evaluate the Protective Efficacy and Safety of a Therapeutic Vaccine, ASP0113, in CMV-Seropositive Recipients Undergoing Allogeneic, Hematopoietic Cell Transplant(HCT)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0000990

Enrollment

500

Registered

2014-01-23

Start date

2014-08-16

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Biological/Vaccine, Non-Stem Cell : Subjects will be randomized in a 1:1 ratio, ASP0113 or placebo, and stratified by donor-recipient relatedness and donor CMV serostatus. The platelet count must be

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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)

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Overall mortality and Cytomegalovirus (CMV) End Organ Disease (EOD)	—

Secondary

Measure	Time frame
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)	—

Countries

Korea, Republic of

Contacts

Public ContactKyungMi Bang

Asan Medical Center

Outcome results