A Study to Evaluate Safety and Tolerability of a Therapeutic Vaccine, ASP0113, in Subjects Undergoing Allogeneic Hematopoietic Cell Transplant
- Registration Number
- NCT01903928
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 9
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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.
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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)
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Subject is scheduled to receive an allogeneic peripheral blood stem cell (PBSC) or bone marrow transplant (BMT) for the treatment of hematologic disorders
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Subject has active CMV disease or infection or has received treatment for active CMV disease or infection within 90 days prior to transplant
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Subject has planned CMV prophylactic therapy with antiviral drugs or CMV-specific immunoglobulins
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Subject has a modified hematopoietic cell transplant comorbidity index (HCT-CI) score > 3
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Subject is known to be positive for human immunodeficiency virus (HIV), hepatitis B surface antigen or hepatitis C ribonucleic acid (RNA)
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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.
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Subject has received an allogeneic stem cell transplant within one year prior to transplant
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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
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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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ASP0113 group ASP0113 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)
- Primary Outcome Measures
Name Time Method Safety assessed by the incidence of adverse events, vital signs, physical exam and labo-tests for 365 days after HCT
- Secondary Outcome Measures
Name Time Method Local reactogenicity for 14 days following each injection protocol-specified reactogenicity scale
Incidence of CMV viremia for 365 days after HCT CMV plasma viral load ≥ 1000 copies
CMV-specified antiviral therapy for 365 days after HCT CMV-specific AVT(Anti-virus therapy) initiated for a CMV plasma viral load ≥ 1000 copies
Incidence of cytomegalovirus end-organ disease (CMV EOD) for 365 days after HCT CMV pneumonia, CMV gastroenteritis, CMV hepatitis, et al
Maximum grade of Graft Versus Host Disease (GVHD) for 365 days after HCT