A PHASE II STUDY OF CELLULAR ADOPTIVE IMMUNOTHERAPY AS PROPHYLAXIS FOR CYTOMEGALOVIRUS DISEASE AFTER ALLOGENEIC BONE MARROW TRANSPLANTATION
OBJECTIVES: I. Determine whether adoptive immunotherapy comprising donor-derived CD8+,
CMV-specific, major histocompatibility complex class I-restricted cytotoxic T-lymphocyte
(CTL) clones (CD8+ CMV-specific CTL clones) and CD4+ CMV-specific T-helper (Th)-cell clones
is effective in preventing CMV viremia and disease in CMV-positive patients with
malignancies requiring allogeneic bone marrow or peripheral blood stem cell transplantation.
II. Determine whether the transfer of CD4+ CMV-specific Th-cell clones to patients with
deficient responses can reconstitute CD4+ Th-cell activity and augment adoptively
transferred CD8+ CMV-specific CTL clones.
OUTLINE: Allogeneic CD8+ CMV-specific, major histocompatibility complex class I-restricted
cytotoxic T-lymphocyte (CTL) clones (CD8+ CMV-specific CTL clones) and CD4+ CMV-specific
T-helper (Th)-cell clones are harvested and cultured in vitro at least 2 weeks before bone
marrow or peripheral blood stem cell (PBSC) transplantation. Bone marrow or PBSC are infused
on day 0. Patients receive the first infusion of CD8+ CMV-specific CTL clones beginning
between days 28 and 45 posttransplantation, followed 8 days later by the second infusion,
followed 2 days later by the first infusion of CD4+ CMV-specific Th-cell clones. Patients
who receive prednisone posttransplantation or have deficient CD8+ CTL responses (i.e., less
than 50% of the response measured in the immunocompetent bone marrow donor) after the second
infusion of CD8+ CMV-specific CTL clones receive a third infusion of CD8+ CMV-specific CTL
clones and a second infusion of CD4+ CMV-specific Th-cell clones before day 67.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 12-18
months.
Interventional
Primary Purpose: Supportive Care
Stan Riddell, MD
Study Chair
Fred Hutchinson Cancer Research Center
United States: Federal Government
1011.01
NCT00002673
June 1995
February 2002
Name | Location |
|---|---|
| Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
