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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Astellas Pharma Inc
Sponsor:
Collaborator:
Vical
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )
ClinicalTrials.gov Identifier:
NCT01877655
First received: June 12, 2013
Last updated: August 28, 2014
Last verified: August 2014
  Purpose

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.


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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

Primary Outcome Measures:
  • Overall mortality [ Time Frame: One year post-transplant ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to first protocol-defined cytomegalovirus (CMV) viremia [ Time Frame: One year post transplant ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Time to first CMV-specific AVT for protocol-defined CMV viremia or CMV end organ disease (EOD) [ Time Frame: One year post-transplant ] [ Designated as safety issue: No ]
  • Incidence of grade 3 treatment-emergent infections other than CMV [ Time Frame: One year post-transplant ] [ Designated as safety issue: No ]
  • Time to grade 3 treatment-emergent infections other than CMV [ Time Frame: One year post-transplant ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: July 2013
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ASP0113 Biological: ASP0113
intramuscular injection
Placebo Comparator: Placebo Drug: Placebo
intramuscular injection

Detailed Description:

The study will be divided into two parts. Part 1 of the study will include the first 100 subjects who are randomized. The purpose of Part 1 is to collect efficacy results to evaluate treatment effect on the primary endpoint and other efficacy endpoints to potentially modify the primary endpoint for being specified for Part 2 of the study.

Part 2 will include the subsequent 400 subjects to evaluate the vaccine efficacy on the incidence of the primary endpoint through one year post-transplant.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01877655

Contacts
Contact: Astellas Pharma Global Development 800-888-7704 ext 5473 clintrials.info@us.astellas.com

  Show 73 Study Locations
Sponsors and Collaborators
Astellas Pharma Global Development, Inc.
Vical
Investigators
Study Director: Medical Director Astellas Pharma Global Development, Inc.
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )
ClinicalTrials.gov Identifier: NCT01877655     History of Changes
Other Study ID Numbers: 0113-CL-1004, 2013-000903-18
Study First Received: June 12, 2013
Last Updated: August 28, 2014
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Canada: Health Canada
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Germany: Paul-Ehrlich-Institut
Korea: Ministry of Food and Drug Safety
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Sweden: Medical Products Agency
Taiwan : Food and Drug Administration
New Zealand: Medsafe

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

ClinicalTrials.gov processed this record on September 16, 2014