CMV reactivation after allogeneic stem cell transplantation. MedDRA version: 19.1 Level: LLT Classification code 10049107 Term: CMV viraemia System Organ Class: 100000004862
Conditions
Interventions
Product Name: ASP0113
Product Code: ASP0113
Pharmaceutical Form: Solution for injection
INN or Proposed INN: not available
CAS Number: 1498125-70-4
Current Sponsor code: ASP0113, VCL-CB01, bivalent va
Sponsors
Astellas Pharma Global Development, Inc. (APGD)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written informedconsent and privacy language as per national regulations (e.g., HIPAA Authorization for U.S. sites) must be obtained from the subject or legally authorized representative prior to any study-specific related procedures (including withdrawal of prohibited medication, if applicable). 2. Subject is a male or female subject who is at least 18 years old or the legal age of consent (whichever is greater). 3. Subject is a CMV-seropositive HCT recipient as confirmed by local laboratory at Screening. 4. Subject is planned to undergo either of the following: a. Sibling Donor Transplant - 7/8 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.* b. Unrelated Donor Transplant - 7/8 or 8/8 HLA-A, -B, -C, -DRß1 match utilizing high resolution typing.* * A minimum of 8 allele matching is required. Subjects with matches performed at more than 8 allelles are included if they have 7/8 or 8/8 match at the HLA-A, -B, -C. –DRß1 allelles. 5. Subject is scheduled to receive an allogeneic peripheral blood stem cell (PBSC) or bone marrow transplant (BMT) for the treatment of hematologic disorders as indicated in Inclusion Criterion 6. 6. Subject has one of the following underlying diseases a. Acute myeloid leukemia (AML), with or without a history of myelodysplastic syndrome, in first or second complete remission or in early relapse ( 50% response to chemotherapy). 7. Female subject must be either: * Of non-child bearing potential: o post-menopausal (defined as at least 1 year without any menses) prior to Screening and if < 50 years of age and not documented to be surgically sterile must have a negative urine or serum pregnancy test at screening, or o documented surgically sterile or status post hysterectomy (at least 1 month prior to Screening). Or, if of childbearing potential: o must have a negative urine or serum pregnancy test at Screening, and o if heterosexually active, must use at least one form of birth control* (which must be a barrier method) starting at Scre
Exclusion criteria
Exclusion criteria: 1. Subject has active CMV disease or infection or has received treatment for active CMV disease or infection within 3 months (90 days) prior to transplant. 2. Subject has planned CMV prophylactic therapy with antiviral drugs or CMV-specific immunoglobulins from randomization through the primary study period completion/Day 365 Visit (V 14). 3. Subject has a modified hematopoietic cell transplant comorbidity index (HCT-CI) score = 4. 4. Subject is known to be positive for human immunodeficiency virus (HIV), hepatitis B surface antigen or hepatitis C RNA polymerase chain reaction (PCR). 5. Donor CMV serostatus is unknown. 6. Subject has received any of the following substances or treatments: a. 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. b. T cell depletion of donor cell product. c. Administration of a CMV vaccine, including any prior exposure to ASP0113. 7. Subject has received an allogeneic stem cell transplant within one year prior to transplant (subjects who have received a prior autologous transplant are allowed). 8. 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 (within the past 5 years prior to Screening) except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully or cancer in situ of the cervix uteri that has been handled by local surgery. 9. 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. 10. Subject has had an allergic reaction to any component of the vaccine. Subject has had an allergic reaction to aminoglycosides as kanamycin is used in the manufacturing process of the vaccine. 11. Subject has participated in any interventional clinical study or has been treated with any investigational research products within 30 days or 5 halflives, whichever is longer, prior to the initiation of Screening. (Investigational research products are considered those products that have not been approved for any indication in the country where the subject is enrolled. New regimens of approved chemotherapeutic drugs or antibodies, conditioning drugs, irradiation and T-cell depleting antibodies, except alemtuzumab, are allowed.) 12. Subject has received a prior HCT and has residual cGVHD. 13. Subject who is scheduled to have a cord blood transplant or a haploidentical transplant. 14. Subject has a platelet count of less than 50,000 mm3 within 3 days prior to randomization (platelet transfusions are allowed). Results received in an equivalent local unit of measure must be converted to SI units. 15. Subject has aplastic anemia or multiple myeloma. 16. For sites in Japan only: Other subjects considered ineligible by the Investigator/sub-Investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To evaluate the efficacy of ASP0113 compared with placebo as measured by a primary composite endpoint of overall mortality and CMV end organ disease (EOD) through one year post-transplant. • To evaluate the safety of ASP0113 in subjects undergoing allogeneic HCT;Secondary Objective: Not applicable ;Primary end point(s): The primary endpoint of the study is the composite of overall mortality and CMV EOD through 1 year post-transplant.;Timepoint(s) of evaluation of this end point: Through one year post-transplant. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Time to first protocol-defined CMV viremia load [CMV plasma viral = 1000 IU/mL as assessed by the central laboratory] through 1 year post-transplant. • Time to first adjudicated CMV-specific AVT through 1 year post – transplant. • Time to first CMV-specific AVT for protocol-defined CMV viremia [CMV plasma viral load = 1000 IU/mL as assessed by the central laboratory] or CMV EOD through one year post-transplant. ;Timepoint(s) of evaluation of this end point: Through one year post-transplant. | — |
Countries
Australia, Belgium, Canada, France, Germany, Japan, Korea, Democratic People's Republic of, Spain, Sweden, Taiwan, United States
Contacts
Public ContactAstellas Pharma Service Desk
Astellas Pharma Europe B.V.
Outcome results
None listed