Non Hodgkin Lymphoma Clinical Trial
Cytomegalovirus (CMV) Vaccine in Donors and Recipients Undergoing Allogeneic Hematopoietic Cell Transplant (HCT)
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).
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.
males and females age 18-65
5/6 or 6/6 classic HLA allele-matched donor
planned GCSF-mobilized peripheral blood stem cell transplant
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
planned prophylactic cytomegalovirus antiviral therapy
planned immunosuppression with alemtuzumab (CAMPATH-IH)
planned prophylactic therapy with CMV immunoglobulin
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There are 22 Locations for this study
Tucson Arizona, 85724, United States
Duarte California, 91010, United States
Denver Colorado, 80218, United States
Tampa Florida, 33612, United States
Atlanta Georgia, 30322, United States
Chicago Illinois, 60612, United States
Chicago Illinois, 60637, United States
Westwood Kansas, 66205, United States
Louisville Kentucky, 40202, United States
Boston Massachusetts, 02115, United States
Detroit Michigan, 48201, United States
Rochester Minnesota, 55905, United States
Omaha Nebraska, 68198, United States
Hackensack New Jersey, 07601, United States
Bronx New York, 10467, United States
Buffalo New York, 14263, United States
New York New York, 10021, United States
Rochester New York, 14642, United States
Winston-Salem North Carolina, 27157, United States
Dallas Texas, 75246, United States
Dallas Texas, 75390, United States
Seattle Washington, 98109, United States
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