Phase 3 N=514 Randomized Quadruple-blind Prevention

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

Cytomegalovirus (CMV)-Positive Recipients · Allogeneic, Hematopoietic Cell Transplant (HCT)

Bottom Line

View on ClinicalTrials.gov: NCT01877655 ↗

Enrolled (actual)

514

Serious AEs

88.2%

Results posted

Nov 2018

Primary outcome: Primary: Percentage of Participants With Composite of All-Cause Mortality and Adjudicated Cytomegalovirus End Organ Disease (CMV EOD) Through 1 Year Post Transplant — 30.20; 35.37; 28.24; 31.71 Percentage of Participants — p=0.205

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: ASP0113 (Biological); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Astellas Pharma Global Development, Inc.
Primary completion: Sep 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With Composite of All-Cause Mortality and Adjudicated Cytomegalovirus End Organ Disease (CMV EOD) Through 1 Year Post Transplant	30.20; 35.37; 28.24; 31.71; 3.53; 6.10	0.205
SECONDARY Percentage of Participants With Protocol-Defined CMV Viremia Through 1 Year Posttransplant	58.6; 56.7	0.748
SECONDARY Percentage of Participants With Adjudicated CMV-Specific Antiviral Therapy (AVT) Through 1 Year Posttransplant	53.2; 54.6	0.888
SECONDARY Percentage of Participants With a Composite Endpoint of Protocol-defined CMV Viremia and Adjudicated CMV-Specific AVT Use	60.78; 60.98	0.802
SECONDARY Percentage of Participants With First Occurrence of Adjudicated CMV-specific AVT or Adjudicated Diagnosis of CMV EOD After Study Drug First Injection Through 1 Year Posttransplant	54.4; 55.4	0.928
SECONDARY All-Cause Mortality at 1 Year Posttransplant	28.24; 31.71	0.393

Summary

The purpose of the study was to evaluate the efficacy of ASP0113 compared with placebo as measured by a primary composite endpoint of overall mortality and CMV end organ disease (EOD) through 1 year post-transplant. Safety of ASP0113 in participants undergoing allogeneic HCT will also be evaluated.

Eligibility Criteria

Inclusion Criteria

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)

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01877655). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.