A Phase 2 Clinical Trial to Evaluate the Safety, Immunogenicity, and Clinical Benefit of a CMV Immunotherapeutic Vaccine in Donors and CMV-Seropositive Recipients Undergoing Allogeneic, Matched Hematopoietic Cell Transplant (HCT)
18 Years
65 Years
Both
Acute Lymphoblastic Leukemia, Chronic Myelogenous Leukemia, Acute Myelogenous Leukemia, Hodgkin's Lymphoma, Non-Hodgkin's Lymphoma, Myelodysplastic Syndrome
Trial Information
A Phase 2 Clinical Trial to Evaluate the Safety, Immunogenicity, and Clinical Benefit of a CMV Immunotherapeutic Vaccine in Donors and CMV-Seropositive Recipients Undergoing Allogeneic, Matched Hematopoietic Cell Transplant (HCT)
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Safety of CMV immunotherapeutic vaccine in donors and recipients undergoing HCT
Outcome Time Frame:
1 year
Safety Issue:
Yes
Principal Investigator
Richard T. Kenney, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Vical
Authority:
United States: Food and Drug Administration
Study ID:
CB01-202
NCT ID:
NCT00285259
Start Date:
January 2006
Completion Date:
November 2010
Related Keywords:
- Acute Lymphoblastic Leukemia
- Chronic Myelogenous Leukemia
- Acute Myelogenous Leukemia
- Hodgkin's Lymphoma
- Non-Hodgkin's Lymphoma
- Myelodysplastic Syndrome
- 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
- Hodgkin Disease
- Leukemia
- Leukemia, Lymphoid
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Leukemia, Myeloid, Acute
- Leukemia, Myeloid
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
- Lymphoma
- Lymphoma, Non-Hodgkin
- Myelodysplastic Syndromes
- Preleukemia
Name | Location |
|---|---|
| Arizona Cancer Center | Tucson, Arizona 85724 |
| Memorial Sloan Kettering Cancer Center | New York, New York 10021 |
| Mayo Clinic | Rochester, Minnesota 55905 |
| Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
| James Graham Brown Cancer Center | Louisville, Kentucky 40202 |
| Rush University Medical Center | Chicago, Illinois 60612-3824 |
| University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
| University of Nebraska Medical Center | Omaha, Nebraska 68198-3330 |
| Montefiore Medical Center | Bronx, New York 10467-2490 |
| Rocky Mountain Cancer Center | Denver, Colorado 80218 |
| City of Hope National Medical Center | Los Angeles, California 91010 |
| Brigham and Women's Hospital | Boston, Massachusetts 02115 |
| University of Texas Southwestern Medical Center at Dallas | Dallas, Texas 75235-8897 |
| Baylor University Medical Center | Dallas, Texas 75246 |
| Emory University | Atlanta, Georgia 30322 |
| University of Chicago | Chicago, Illinois 60637 |
| Karmanos Cancer Institute | Detroit, Michigan 48201 |
| University of South Florida | Tampa, Florida 33612 |
| Hackensack University Medical Center # 408 | Hackensack, New Jersey 07601 |
| Roswell Park Cancer Institute Corporation | Buffalo, New York 14263 |
| Strong Memorial Hospital | Rochester, New York 14642 |
| North Carolina Baptist Hosptial | Winston-Salem, North Carolina 27157 |
