Status:
COMPLETED
A Study to Evaluate Safety and Tolerability of a Therapeutic Vaccine, ASP0113, in Subjects Undergoing Allogeneic Hematopoietic Cell Transplant
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Allogeneic Hematopoietic Cell Transplant
Eligibility:
All Genders
20+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 20 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 19 2015
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT01903928
Start Date
June 20 2013
End Date
January 19 2015
Last Update
October 17 2024
Active Locations (2)
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1
Kantou, Japan
2
Kyushu, Japan