Allogeneic Hematopoietic Cell Transplant
Conditions
Keywords
cytomegalovirus, HCT, DNA vaccine, transplantation
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.
Interventions
BIOLOGICALASP0113
injection
Sponsors
Astellas Pharma Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety assessed by the incidence of adverse events, vital signs, physical exam and labo-tests | for 365 days after HCT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
Japan
Outcome results
None listed