Acute Lymphoblastic Leukemia, Acute Myelogenous Leukemia, Chronic Myelogenous Leukemia, Hodgkin's Lymphoma, Myelodysplastic Syndrome, Non-Hodgkin's Lymphoma
Conditions
Keywords
cytomegalovirus infection, infectious disease, viremia, cytomegalovirus disease, stem cell transplant, allogeneic, bone marrow transplant, hematopoietic cell transplant, Acute Lymphoblastic Leukemia, Chronic Myelogenous Leukemia, Acute Myelogenous Leukemia, Hodgkin's Lymphoma, Non-Hodgkin's Lymphoma, Myelodysplastic Syndrome
Brief summary
The purpose of this trial is to evaluate a CMV vaccine given to related donor/recipient pairs (donors prior to peripheral blood stem cell donation and CMV-seropositive recipients just before and after transplantation) and CMV-seropositive recipient-only subjects (related or unrelated) to determine incidence rates of CMV infection, disease, and other complications from immunosuppression and/or transplantation. The outcomes for the groups receiving CMV vaccine will be compared to the outcomes for the group that received the placebo vaccine to see if there is a clinical benefit. For this trial, donors and recipients must have matched HLA genotype (matched at 5/6 or 6/6 HLA loci).
Detailed description
This study was run by Vical and the record was transferred to Astellas on 1/8/2013. Trial will enroll up to 240 subjects (160 recipients and 80 donors). Qualified donors and/or CMV-seropositive recipients (donor/recipient pairs or recipient-only subjects) will be assigned randomly to receive either a CMV vaccine or a placebo vaccine. Donors will receive 3 vaccines prior to donation and recipients will receive 1 vaccine pretransplant and up to three vaccines posttransplant. Recipients will be followed for up to 1 year after transplant to evaluate the safety of the vaccine and to see if there is a clinical benefit in the group that received the CMV vaccine. The incidence rates of CMV infection, disease, and other complications from immunosuppression and/or transplantation will be studied.
Interventions
BIOLOGICALVCL-CB01
5 mg/mL, Intramuscular (IM.) 3 vaccinations for donors; 1 vaccination pretransplant, up to 3 vaccinations after transplant for recipients
1 mL, IM. 3 vaccinations for donors; 1 vaccination pretransplant, up to 3 vaccinations after transplant for recipients
Sponsors
Vical
Astellas Pharma Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* males and females age 18-65 * 5/6 or 6/6 classic HLA allele-matched donor * planned GCSF-mobilized peripheral blood stem cell transplant * CMV-seropositive recipient * planned transplant with minimal or no T-cell depletion * Acute Lymphoblastic Leukemia (ALL) in first or second remission; Acute Myeloid Leukemia (AML) in first or second remission; Chronic Myelogenous Leukemia (CML) in first chronic or accelerated phase, or in second chronic phase; Hodgkin's and non-Hodgkin's lymphoma; myelodysplastic syndrome
Exclusion criteria
* planned prophylactic cytomegalovirus antiviral therapy * planned immunosuppression with alemtuzumab (CAMPATH-IH) * planned prophylactic therapy with CMV immunoglobulin * autoimmune disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety of CMV immunotherapeutic vaccine in donors and recipients undergoing HCT | 1 year |
| occurrence rate of clinically significant CMV viremia in recipients receiving CMV immunotherapeutic vaccine. | 1 year |
Countries
United States
Outcome results
None listed