A Study to Evaluate a Therapeutic Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seropositive Recipients Undergoing Allogeneic, Hematopoietic Cell Transplant (HCT)
NCT ID: NCT01877655
Last Updated: 2024-10-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
514 participants
INTERVENTIONAL
2013-09-11
2022-03-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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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).
ASP0113
Intramuscular injection
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).
Placebo
Intramuscular injection
Interventions
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ASP0113
Intramuscular injection
Placebo
Intramuscular injection
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Astellas Pharma Global Development, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Astellas Pharma Global Development, Inc.
Locations
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Site US10028
Birmingham, Alabama, United States
Site US10044
Tucson, Arizona, United States
Site US10035
San Francisco, California, United States
Site US10026
Stanford, California, United States
Site US10030
Tampa, Florida, United States
Site US10012
Atlanta, Georgia, United States
Site US10013
Chicago, Illinois, United States
Site US10007
Indianapolis, Indiana, United States
Site US10020
Westwood, Kansas, United States
Site US10010
Louisville, Kentucky, United States
Site US10043
Baltimore, Maryland, United States
Site US10011
Baltimore, Maryland, United States
Site US10021
Boston, Massachusetts, United States
Site US10036
Rochester, Minnesota, United States
Site US10042
St Louis, Missouri, United States
Site US10023
Hackensack, New Jersey, United States
Site US10047
New York, New York, United States
Site US10027
Rochester, New York, United States
Site US10025
Chapel Hill, North Carolina, United States
Site US10016
Nashville, Tennessee, United States
Site US10002
Dallas, Texas, United States
Site US10045
Houston, Texas, United States
Site US10046
Salt Lake City, Utah, United States
Site US10031
Richmond, Virginia, United States
Site US10039
Seattle, Washington, United States
Site US10024
Seattle, Washington, United States
Site US10019
Milwaukee, Wisconsin, United States
Site AU43001
Herston, Queensland, Australia
Site AU43004
Adelaide, South Australia, Australia
Site BE32001
Bruges, , Belgium
Site BE32005
Leuven, , Belgium
Site BE32007
Roeselare, , Belgium
Site CA15001
Vancouver, British Columbia, Canada
Site CA15002
Toronto, Ontario, Canada
Site CA15004
Montreal, Quebec, Canada
Site CA15003
Québec, Quebec, Canada
Site FR33011
Besançon, , France
Site FR33005
Créteil, , France
Site FR33009
Nantes, , France
Site FR33010
Nice, , France
Site DE49010
Bonn, , Germany
Site DE49014
Cologne, , Germany
Site DE49012
Düsseldorf, , Germany
Site DE49013
Göttingen, , Germany
Site DE49002
Leipzig, , Germany
Site DE49015
Mainz, , Germany
Site DE49007
Münster, , Germany
Site DE49005
Stuttgart, , Germany
Site DE49008
Tübingen, , Germany
Site DE49006
Ulm, , Germany
Site DE49001
Würzburg, , Germany
Site JP81003
Nagoya, Aichi-ken, Japan
Site JP81011
Maebashi, Gunma, Japan
Site JP81007
Sapporo, Hokkaido, Japan
Site JP81010
Bunkyo-ku, Tokyo, Japan
Site JP81008
Chuo-ku, Tokyo, Japan
Site JP81009
Minato-ku, Tokyo, Japan
Site JP81004
Shinjuku-ku, Tokyo, Japan
Site JP81001
Fukuoka, , Japan
Site JP81005
Fukuoka, , Japan
Site JP81006
Osaka, , Japan
Site KR82004
Seoul, Seoul Teugbyeolsi, South Korea
Site KR82002
Seoul, , South Korea
Site KR82003
Seoul, , South Korea
Site KR82001
Seoul, , South Korea
Site ES34001
Badalona, , Spain
Site ES34006
Barcelona, , Spain
Site ES34004
Barcelona, , Spain
Site ES34005
Córdoba, , Spain
Site ES34003
Granada, , Spain
Site ES34011
Madrid, , Spain
Site ES34007
Murcia, , Spain
Site ES34010
Salamanca, , Spain
Site ES34002
Santander, , Spain
Site ES34009
Valencia, , Spain
Site SE46001
Gothenburg, , Sweden
Site SE46006
Linköping, , Sweden
Site SE46004
Lund, , Sweden
Site SE46003
Stockholm, , Sweden
Site SE46005
Umeå, , Sweden
Site TW88601
Taipei, , Taiwan
Site TW88602
Taipei, , Taiwan
Site TW88603
Taoyuan, , Taiwan
Countries
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References
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Ljungman P, Bermudez A, Logan AC, Kharfan-Dabaja MA, Chevallier P, Martino R, Wulf G, Selleslag D, Kakihana K, Langston A, Lee DG, Solano C, Okamoto S, Smith LR, Boeckh M, Wingard JR, Cywin B, Fredericks C, Lademacher C, Wang X, Young J, Maertens J. A randomised, placebo-controlled phase 3 study to evaluate the efficacy and safety of ASP0113, a DNA-based CMV vaccine, in seropositive allogeneic haematopoietic cell transplant recipients. EClinicalMedicine. 2021 Mar 19;33:100787. doi: 10.1016/j.eclinm.2021.100787. eCollection 2021 Mar.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Link to results and other applicable study documents on the Astellas Clinical Trials website
Link to plain language summary of the study on the Trial Results Summaries website
Other Identifiers
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2013-000903-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
0113-CL-1004
Identifier Type: -
Identifier Source: org_study_id
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