Status:
COMPLETED
Cytomegalovirus (CMV) Vaccine in Donors and Recipients Undergoing Allogeneic Hematopoietic Cell Transplant (HCT)
Lead Sponsor:
Astellas Pharma Inc
Collaborating Sponsors:
Vical
Conditions:
Acute Lymphoblastic Leukemia
Chronic Myelogenous Leukemia
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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...
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 recip...
Eligibility Criteria
Inclusion
- 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
- planned prophylactic cytomegalovirus antiviral therapy
- planned immunosuppression with alemtuzumab (CAMPATH-IH)
- planned prophylactic therapy with CMV immunoglobulin
- autoimmune disease
Key Trial Info
Start Date :
January 31 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2010
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT00285259
Start Date
January 31 2006
End Date
November 30 2010
Last Update
October 21 2024
Active Locations (22)
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1
Arizona Cancer Center
Tucson, Arizona, United States, 85724
2
City of Hope National Medical Center
Duarte, California, United States, 91010
3
Rocky Mountain Cancer Center
Denver, Colorado, United States, 80218
4
University of South Florida
Tampa, Florida, United States, 33612