Cytomegalovirus (CMV) Vaccine in Donors and Recipients Undergoing Allogeneic Hematopoietic Cell Transplant (HCT)

Completed · Phase 2 · Has a placebo group

Conditions studied: Acute Lymphoblastic Leukemia, Chronic Myelogenous Leukemia, Acute Myelogenous Leukemia, Hodgkin's Lymphoma, Non-Hodgkin's Lymphoma, Myelodysplastic Syndrome

In brief

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).

Key facts

Study ID

NCT00285259

Run by

Astellas Pharma Inc

People needed

112

Starts

2006-01-31

Expected to finish

2010-11-30

Last updated by the study team

2024-10-21

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• planned prophylactic cytomegalovirus antiviral therapy
• planned immunosuppression with alemtuzumab (CAMPATH-IH)
• planned prophylactic therapy with CMV immunoglobulin
• autoimmune disease

Where it is running

• Arizona Cancer Center — Tucson, Arizona, United States
• City of Hope National Medical Center — Duarte, California, United States
• Rocky Mountain Cancer Center — Denver, Colorado, United States
• University of South Florida — Tampa, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Rush University Medical Center — Chicago, Illinois, United States
• University of Chicago — Chicago, Illinois, United States
• University of Kansas Medical Center — Westwood, Kansas, United States
• James Graham Brown Cancer Center — Louisville, Kentucky, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Karmanos Cancer Institute — Detroit, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Hackensack University Medical Center # 408 — Hackensack, New Jersey, United States
• Roswell Park Cancer Institute Corporation — Buffalo, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Strong Memorial Hospital — Rochester, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• North Carolina Baptist Hosptial — Winston-Salem, North Carolina, United States
• Baylor University Medical Center — Dallas, Texas, United States
• University of Texas Southwestern Medical Center at Dallas — Dallas, Texas, United States
• Fred Hutchinson Cancer Research Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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