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A Study to Evaluate Safety and Tolerability of a Therapeutic Vaccine, ASP0113, in Subjects Undergoing Allogeneic Hematopoietic Cell Transplant

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ClinicalTrials.gov Identifier: NCT01903928
Recruitment Status : Completed
First Posted : July 19, 2013
Last Update Posted : January 23, 2019
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

Brief Summary:
This study is to evaluate safety and tolerability of a therapeutic vaccine, ASP0113, in subjects undergoing allogeneic HCT. The occurrence of CMV viremia and immunogenicity are also assessed.

Condition or disease Intervention/treatment Phase
Allogeneic Hematopoietic Cell Transplant Biological: ASP0113 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Phase 2 Trial to Evaluate Safety of a Therapeutic Vaccine, ASP0113, in Recipients Undergoing Allogeneic Hematopoietic Cell Transplant (HCT)
Actual Study Start Date : June 20, 2013
Actual Primary Completion Date : January 19, 2015
Actual Study Completion Date : January 19, 2015

Arm Intervention/treatment
Experimental: ASP0113 group
Participants receive 1 mL of ASP0113 intramuscularly 5 times, on days −14 to −3, 14 to 40, 60 ± 5, 90 ± 10, and 180 ± 10, counting from the transplantation (stem cell transfusion) day (day 0)
Biological: ASP0113
injection




Primary Outcome Measures :
  1. Safety assessed by the incidence of adverse events, vital signs, physical exam and labo-tests [ Time Frame: for 365 days after HCT ]

Secondary Outcome Measures :
  1. Local reactogenicity [ Time Frame: for 14 days following each injection ]
    protocol-specified reactogenicity scale

  2. Incidence of CMV viremia [ Time Frame: for 365 days after HCT ]
    CMV plasma viral load ≥ 1000 copies

  3. CMV-specified antiviral therapy [ Time Frame: for 365 days after HCT ]
    CMV-specific AVT(Anti-virus therapy) initiated for a CMV plasma viral load ≥ 1000 copies

  4. Incidence of cytomegalovirus end-organ disease (CMV EOD) [ Time Frame: for 365 days after HCT ]
    CMV pneumonia, CMV gastroenteritis, CMV hepatitis, et al

  5. Maximum grade of Graft Versus Host Disease (GVHD) [ Time Frame: for 365 days after HCT ]


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject is planned to undergo either of the following:

    • Sibling Donor Transplant - 7/8 Human Leukocyte Antigen (HLA)-A, -B, -C, -DRß1 match utilizing high resolution typing or 8/8 (HLA)-A, -B, -C, -DRß1 match utilizing low or high resolution typing.
    • Unrelated Donor Transplant - 7/8 or 8/8 HLA-A, -B, -C, -DRß1 match utilizing high resolution typing.
  • 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) / myelodysplastic syndrome(s) (MDS)
  • Subject is scheduled to receive an allogeneic peripheral blood stem cell (PBSC) or bone marrow transplant (BMT) for the treatment of hematologic disorders

Exclusion Criteria:

  • Subject has active CMV disease or infection or has received treatment for active CMV disease or infection within 90 days prior to transplant
  • Subject has planned CMV prophylactic therapy with antiviral drugs or CMV-specific immunoglobulins
  • Subject has a modified hematopoietic cell transplant comorbidity index (HCT-CI) score > 3
  • Subject is known to be positive for human immunodeficiency virus (HIV), hepatitis B surface antigen or hepatitis C ribonucleic acid (RNA)
  • Subject has received any of the following substances or treatments:

    • T-cell depletion of donor cell product.
    • Alemtuzumab within 60 days prior to transplant, including conditioning regimen. Subjects for whom treatment with alemtuzumab is planned at any time from 60 days prior to through one year post-transplant should not be enrolled in the trial.
    • Administration of a CMV vaccine, including any prior exposure to ASP0113.
  • Subject has received an allogeneic stem cell transplant within one year prior to transplant
  • Subject has a current malignancy in addition to the malignancy being treated for the study or the subject has a history of any other malignancy
  • Subject has an unstable medical or psychiatric condition, including a history of illicit drug(s) or alcohol abuse that the Investigator believes will interfere with protocol requirements.

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): NCT01903928


Locations
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Japan
Kantou, Japan
Kyushu, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
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Study Director: Medical Director Astellas Pharma Inc

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01903928     History of Changes
Other Study ID Numbers: 0113-CL-1003
First Posted: July 19, 2013    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."

Keywords provided by Astellas Pharma Inc:
cytomegalovirus
HCT
DNA vaccine
transplantation

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