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

Launched by ASTELLAS PHARMA INC · Jul 17, 2013

Keywords

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Gender

ALL

Eligibility 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.