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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01877655
First Posted: June 14, 2013
Last Update Posted: October 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Vical
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )
  Purpose
The purpose of the study is 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 subjects undergoing allogeneic HCT will also be evaluated.

Condition Intervention Phase
Cytomegalovirus (CMV)-Positive Recipients Allogeneic, Hematopoietic Cell Transplant (HCT) Biological: ASP0113 Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Evaluate the Protective Efficacy and Safety of a Therapeutic Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seropositive Recipients Undergoing Allogeneic, Hematopoietic Cell Transplant (HCT)

Further study details as provided by Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. ):

Primary Outcome Measures:
  • Composite of overall mortality and cytomegalovirus (CMV) End Organ Disease (EOD) through one year post-transplant [ Time Frame: One year post-transplant ]

Secondary Outcome Measures:
  • Time to first protocol-defined CMV viremia [ Time Frame: One year post transplant ]
    CMV viremia defined as CMV plasma viral load ≥ 1000 IU/mL as assessed by the central laboratory

  • Time to first adjudicated CMV-specific anti-viral therapy (AVT) [ Time Frame: One year post-transplant ]
  • Time to first CMV-specific AVT for protocol-defined CMV viremia or CMV EOD [ Time Frame: One year post-transplant ]
    CMV viremia defined as CMV plasma viral load ≥ 1000 IU/mL as assessed by the central laboratory


Enrollment: 514
Actual Study Start Date: September 22, 2013
Estimated Study Completion Date: March 2022
Primary Completion Date: September 28, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ASP0113
ASP0113 arm
Biological: ASP0113
intramuscular injection
Placebo Comparator: Placebo
Placebo arm
Drug: Placebo
intramuscular injection

Detailed Description:
Subjects will be followed for 5.5 years post-transplant for long-term safety via an annual telephone contact.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01877655


  Show 83 Study Locations
Sponsors and Collaborators
Astellas Pharma Global Development, Inc.
Vical
Investigators
Study Director: Medical Director Astellas Pharma Global Development, Inc.
  More Information

Responsible Party: Astellas Pharma Global Development, Inc.
ClinicalTrials.gov Identifier: NCT01877655     History of Changes
Other Study ID Numbers: 0113-CL-1004
2013-000903-18 ( EudraCT Number )
First Submitted: June 12, 2013
First Posted: June 14, 2013
Last Update Posted: October 26, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: An investigational test is being used to measure the cytomegalovirus (CMV) viral load in the plasma.

Keywords provided by Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. ):
ASP0113
Cytomegalovirus (CMV)
Hematopoietic Cell Transplant (HCT)

Additional relevant MeSH terms:
Vaccines
Immunologic Factors
Physiological Effects of Drugs