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

Last updated: October 15, 2024
Sponsor: Astellas Pharma Global Development, Inc.
Overall Status: Completed

Phase

3

Condition

Cytomegalovirus Infections

Treatment

Placebo

ASP0113

Clinical Study ID

NCT01877655
0113-CL-1004
2013-000903-18
  • Ages > 18
  • All Genders

Study 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

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

Exclusion Criteria:

  • Participant has active CMV disease or infection or has received treatment for activeCMV 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-hostDisease (cGVHD)

  • Participant who is scheduled to have a cord blood transplant or a haploidenticaltransplant

  • Participant has a platelet count of less than 50,000 mm3 within 3 days prior torandomization (platelet transfusions are allowed)

  • Participant has aplastic anemia or multiple myeloma

Study Design

Total Participants: 514
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
September 11, 2013
Estimated Completion Date:
March 01, 2022

Study Description

Participants will be followed for 5.5 years post-transplant for long-term safety via an annual telephone contact.

Connect with a study center

  • Site AU43001

    Herston, Queensland QLD 4029
    Australia

    Site Not Available

  • Site AU43004

    Adelaide, South Australia SA 5000
    Australia

    Site Not Available

  • Site AU43002

    Melbourne, Victoria 3004
    Australia

    Site Not Available

  • Site AU43003

    Parkville, Victoria 3050
    Australia

    Site Not Available

  • Site BE32001

    Brugge, 8000
    Belgium

    Site Not Available

  • Site BE32006

    Gent, 9000
    Belgium

    Site Not Available

  • Site BE32005

    Leuven, 3000
    Belgium

    Site Not Available

  • Site BE32007

    Roeselare, 8800
    Belgium

    Site Not Available

  • Site CA15001

    Vancouver, British Columbia V5Z 1M9
    Canada

    Site Not Available

  • Site CA15002

    Toronto, Ontario M5G 2M9
    Canada

    Site Not Available

  • Site CA15004

    Montreal, Quebec H2W 1S6
    Canada

    Site Not Available

  • Site CA15003

    Quebec, G1R 2J6
    Canada

    Site Not Available

  • Site FR33011

    Besancon, 25030
    France

    Site Not Available

  • Site FR33005

    Creteil, 94000
    France

    Site Not Available

  • Site FR33005

    Créteil, 94000
    France

    Site Not Available

  • Site FR33009

    Nantes, 44093
    France

    Site Not Available

  • Site FR33010

    Nice, 06200
    France

    Site Not Available

  • Site FR33004

    Paris, 75475
    France

    Site Not Available

  • Site DE49010

    Bonn, 53127
    Germany

    Site Not Available

  • Site DE49012

    Dusseldorf, 40225
    Germany

    Site Not Available

  • Site DE49012

    Düsseldorf, 40225
    Germany

    Site Not Available

  • Site DE49013

    Gottingen, 37075
    Germany

    Site Not Available

  • Site DE49013

    Göttingen, 37075
    Germany

    Site Not Available

  • Site DE49004

    Jena, 07740
    Germany

    Site Not Available

  • Site DE49014

    Koln, 50937
    Germany

    Site Not Available

  • Site DE49014

    Köln, 50937
    Germany

    Site Not Available

  • Site DE49002

    Leipzig, 04103
    Germany

    Site Not Available

  • Site DE49015

    Mainz, 55131
    Germany

    Site Not Available

  • Site DE49007

    Muenster, 48149
    Germany

    Site Not Available

  • Site DE49007

    Münster, 48149
    Germany

    Site Not Available

  • Site DE49005

    Stuttgart, 70376
    Germany

    Site Not Available

  • Site DE49008

    Tuebingen, 72076
    Germany

    Site Not Available

  • Site DE49006

    Ulm, 89081
    Germany

    Site Not Available

  • Site DE49003

    Wiesbaden, 65191
    Germany

    Site Not Available

  • Site DE49001

    Wurzburg, 97080
    Germany

    Site Not Available

  • Site DE49001

    Würzburg, 97080
    Germany

    Site Not Available

  • Site JP81003

    Nagoya, Aichi
    Japan

    Site Not Available

  • Site JP81011

    Maebashi, Gunma
    Japan

    Site Not Available

  • Site JP81007

    Sapporo, Hokkaido
    Japan

    Site Not Available

  • Site JP81007

    Sapporo City, Hokkaido 060-8638
    Japan

    Site Not Available

  • Site JP81010

    Bunkyo-ku, Tokyo
    Japan

    Site Not Available

  • Site JP81008

    Chuo-ku, Tokyo
    Japan

    Site Not Available

  • Site JP81009

    Minato-ku, Tokyo
    Japan

    Site Not Available

  • Site JP81004

    Shinjuku-ku, Tokyo
    Japan

    Site Not Available

  • Site JP81001

    Fukuoka,
    Japan

    Site Not Available

  • Site JP81005

    Fukuoka,
    Japan

    Site Not Available

  • Site JP81005

    Fukuoka City, 810-8539
    Japan

    Site Not Available

  • Site JP81011

    Gunma, 371-0821
    Japan

    Site Not Available

  • Site JP81007

    Hokkaido, 060-8648
    Japan

    Site Not Available

  • Site JP81003

    Nagoya City, 453-8511
    Japan

    Site Not Available

  • Site JP81006

    Osaka,
    Japan

    Site Not Available

  • Site JP81006

    Osaka City, 8041
    Japan

    Site Not Available

  • Site JP81009

    Tokyo, 105-8470
    Japan

    Site Not Available

  • Site KR82004

    Seoul, Seoul Teugbyeolsi 06351
    Korea, Republic of

    Site Not Available

  • Site KR82001

    Seoul, 137-701
    Korea, Republic of

    Site Not Available

  • Site KR82002

    Seoul, 05505
    Korea, Republic of

    Site Not Available

  • Site KR82003

    Seoul, 110744
    Korea, Republic of

    Site Not Available

  • Site ES34001

    Badalona, 08615
    Spain

    Site Not Available

  • Site ES34004

    Barcelona, 08908
    Spain

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  • Site ES34006

    Barcelona, 08041
    Spain

    Site Not Available

  • Site ES34005

    Cordoba, 14004
    Spain

    Site Not Available

  • Site ES34003

    Granada, 18012
    Spain

    Site Not Available

  • Site ES34004

    L'Hospitalet de Llobregat, 08908
    Spain

    Site Not Available

  • Site ES34011

    Madrid, 28028
    Spain

    Site Not Available

  • Site ES34007

    Murcia, 30008
    Spain

    Site Not Available

  • Site ES34010

    Salamanca, 37007
    Spain

    Site Not Available

  • Site ES34002

    Santander, 39008
    Spain

    Site Not Available

  • Site ES34009

    Valencia, 46010
    Spain

    Site Not Available

  • Site SE46001

    Goteborg, 413 45
    Sweden

    Site Not Available

  • Site SE46001

    Gothenburg, 413 45
    Sweden

    Site Not Available

  • Site SE46001

    Göteborg, 413 45
    Sweden

    Site Not Available

  • Site SE46006

    Linkoping, 581 85
    Sweden

    Site Not Available

  • Site SE46006

    Linköping, 58185
    Sweden

    Site Not Available

  • Site SE46004

    Lund, 221 85
    Sweden

    Site Not Available

  • Site SE46003

    Stockholm, 14186
    Sweden

    Site Not Available

  • Site SE46005

    Umea, 901 85
    Sweden

    Site Not Available

  • Site SE46005

    Umeå, 901 85
    Sweden

    Site Not Available

  • Site TW88601

    Taipei City, 10002
    Taiwan

    Site Not Available

  • Site TW88602

    Taipei City, 11217
    Taiwan

    Site Not Available

  • Site TW88603

    Taoyuan County, 33305
    Taiwan

    Site Not Available

  • Site US10028

    Birmingham, Alabama 35294
    United States

    Site Not Available

  • Site US10044

    Tucson, Arizona 85724
    United States

    Site Not Available

  • Site US10035

    San Francisco, California 94143
    United States

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  • Site US10026

    Stanford, California 94305
    United States

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  • Site US10030

    Tampa, Florida 33612
    United States

    Site Not Available

  • Site US10012

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Site US10013

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Site US10007

    Indianapolis, Indiana 46237
    United States

    Site Not Available

  • Site US10020

    Westwood, Kansas 66205
    United States

    Site Not Available

  • Site US10010

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Site US10011

    Baltimore, Maryland 21205
    United States

    Site Not Available

  • Site US10043

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • Site US10021

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Site US10036

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Site US10042

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Site US10042

    St. Louis, Missouri 63110
    United States

    Site Not Available

  • Site US10023

    Hackensack, New Jersey 07601-2105
    United States

    Site Not Available

  • Site US10047

    New York, New York 10032
    United States

    Site Not Available

  • Site US10027

    Rochester, New York 14642
    United States

    Site Not Available

  • Site US10025

    Chapel Hill, North Carolina 27514
    United States

    Site Not Available

  • Site US10029

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • Site US10033

    Portland, Oregon 97239
    United States

    Site Not Available

  • Site US10016

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • Site US10002

    Dallas, Texas 75246
    United States

    Site Not Available

  • Site US10045

    Houston, Texas 77030
    United States

    Site Not Available

  • Site US10046

    Salt Lake City, Utah 84143
    United States

    Site Not Available

  • Site US10031

    Richmond, Virginia 23298
    United States

    Site Not Available

  • Site US10024

    Seattle, Washington 98109
    United States

    Site Not Available

  • Site US10039

    Seattle, Washington 98108
    United States

    Site Not Available

  • Site US10019

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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