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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01877655


Additional trial details provided through ANZCTR are available at the end of this record.


Registration number
NCT01877655
Ethics application status
Date submitted
12/06/2013
Date registered
14/06/2013

Titles & IDs
Public title
A Study to Evaluate a Therapeutic Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seropositive Recipients Undergoing Allogeneic, Hematopoietic Cell Transplant (HCT)
Scientific 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)
Secondary ID [1] 0 0
2013-000903-18
Secondary ID [2] 0 0
0113-CL-1004
Universal Trial Number (UTN)
Trial acronym
HELIOS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cytomegalovirus (CMV)-Positive Recipients 0 0
Allogeneic, Hematopoietic Cell Transplant (HCT) 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - ASP0113
Treatment: Drugs - Placebo

Experimental: ASP0113 - Participants received 1 mL of 5 mg/mL of ASP0113 via intramuscular injection in the deltoid muscle alternating sides with each dose on days -14 to -3 pretransplant, 14 to 40, 60, 90 and 180 in relation to the day of transplant (Day 0).

Placebo comparator: Placebo - Participants received 1 mL of 5 mg/mL of matching placebo via intramuscular injection in the deltoid muscle alternating sides with each dose on days -14 to -3 pretransplant, 14 to 40, 60, 90 and 180 in relation to the day of transplant (Day 0).


Treatment: Other: ASP0113
Intramuscular injection

Treatment: Drugs: Placebo
Intramuscular injection
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Composite of All-Cause Mortality and Adjudicated Cytomegalovirus End Organ Disease (CMV EOD) Through 1 Year Post Transplant
Timepoint [1] 0 0
From first study dose injection (Day -14 to -3 prior to transplant) up to one year post study drug injection (Day 365)
Secondary outcome [1] 0 0
Percentage of Participants With Protocol-Defined CMV Viremia Through 1 Year Posttransplant
Timepoint [1] 0 0
From first study dose injection (Day -14 to -3 prior to transplant) up to one year post study drug injection (Day 365)
Secondary outcome [2] 0 0
Percentage of Participants With Adjudicated CMV-Specific Antiviral Therapy (AVT) Through 1 Year Posttransplant
Timepoint [2] 0 0
From first study dose injection (Day -14 to -3 prior to transplant) up to one year post study drug injection (Day 365)
Secondary outcome [3] 0 0
Percentage of Participants With a Composite Endpoint of Protocol-defined CMV Viremia and Adjudicated CMV-Specific AVT Use
Timepoint [3] 0 0
From first study dose injection (Day -14 to -3 prior to transplant) up to one year post study drug injection (Day 365)
Secondary outcome [4] 0 0
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
Timepoint [4] 0 0
From first study dose injection (Day -14 to -3 prior to transplant) up to one year post study drug injection (Day 365)
Secondary outcome [5] 0 0
All-Cause Mortality at 1 Year Posttransplant
Timepoint [5] 0 0
From first study dose injection (Day -14 to -3 prior to transplant) up to one year post study drug injection (Day 365)

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/09/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2022
Sample size
Target
Accrual to date
Final
514
Recruitment in Australia
Recruitment state(s)
QLD,SA
Recruitment hospital [1] 0 0
Site AU43001 - Herston
Recruitment hospital [2] 0 0
Site AU43004 - Adelaide
Recruitment postcode(s) [1] 0 0
QLD 4029 - Herston
Recruitment postcode(s) [2] 0 0
SA 5000 - Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
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Arizona
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United States of America
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California
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Florida
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United States of America
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Georgia
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United States of America
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Illinois
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Indiana
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United States of America
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Kansas
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Kentucky
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United States of America
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Maryland
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Massachusetts
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Minnesota
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Missouri
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New Jersey
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New York
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North Carolina
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Tennessee
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Texas
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Utah
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Virginia
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Washington
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United States of America
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Wisconsin
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Belgium
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Brugge
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Belgium
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Leuven
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Belgium
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Roeselare
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Canada
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British Columbia
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Canada
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Ontario
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Canada
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Quebec
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France
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Besancon
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France
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Creteil
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France
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Nantes
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France
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Nice
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Germany
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Bonn
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Germany
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Dusseldorf
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Germany
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Gottingen
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Germany
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Koln
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Germany
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Leipzig
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Germany
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Mainz
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Germany
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Muenster
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Germany
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Stuttgart
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Germany
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Tuebingen
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Germany
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Ulm
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Germany
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Wurzburg
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Japan
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Aichi
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Japan
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Gunma
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Japan
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Hokkaido
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Japan
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Tokyo
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Japan
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Fukuoka
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Japan
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Osaka
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Korea, Republic of
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Seoul Teugbyeolsi
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Korea, Republic of
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Seoul
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Spain
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Badalona
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Spain
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Barcelona
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Spain
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Cordoba
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Spain
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Granada
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Spain
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Madrid
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Spain
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Murcia
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Spain
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Salamanca
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Spain
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Santander
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Spain
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Valencia
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Sweden
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Gothenburg
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Sweden
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Linkoping
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Sweden
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Lund
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Sweden
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Stockholm
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Sweden
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Umea
Country [66] 0 0
Taiwan
State/province [66] 0 0
Taipei City
Country [67] 0 0
Taiwan
State/province [67] 0 0
Taoyuan County

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Astellas Pharma Global Development, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Astellas Pharma Global Development, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
Available to whom?
Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.clinicalstudydatarequest.com/


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT01877655

Additional trial details provided through ANZCTR
Accrual to date
Recruitment state(s)
Funding & Sponsors
Primary sponsor
Primary sponsor name
Primary sponsor address
Primary sponsor country
Ethics approval
Ethics application status
 
Public notes
Please refer to ClinicalTrials.gov website link (https://clinicaltrials.gov/ct2/show/results/NCT01877655?term=0113-cl-1004&draw=2&rank=1) and EU CTR website link (https://www.clinicaltrialsregister.eu/ctr-search/trial/2013-000903-18/results) for results for this study.

Contacts
Principal investigator
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Name 357 0
Address 357 0
Country 357 0
Phone 357 0
Fax 357 0
Email 357 0
Contact person for public queries
Title 358 0
Name 358 0
Address 358 0
Country 358 0
Phone 358 0
Fax 358 0
Email 358 0
Contact person for scientific queries
Title 359 0
Name 359 0
Address 359 0
Country 359 0
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Email 359 0