A Phase I Study of Photochemically Treated Donor T-Cell Supplements in HLA Haplotype Mismatched Hematopoietic Stem Cell Transplantation
OBJECTIVES: I. Determine the maximum tolerated dose of T-cells photochemically treated with
psoralen and ultraviolet A given with peripheral stem cell transplantation in patients with
hematologic malignancies or bone marrow failure myelodysplastic syndrome. II. Assess the
toxicity of this treatment in these patients. III. Evaluate this regimen in terms of
prevention of graft versus host disease and control of malignancy in these patients.
OUTLINE: This is a dose escalation, multicenter study of T-cells photochemically treated
with psoralen and ultraviolet A. Patients receive thiotepa IV over 2 hours on day 1,
cyclophosphamide IV over 2 hours on days 2 and 3, and whole body radiotherapy on days 5-8.
Patients undergo preserved stem cell or bone marrow allogeneic transplant plus psoralen
treated T-cell allogeneic transplant on day 9. Cohorts of 3-6 patients receive escalating
doses of photochemically treated T-cells until the maximum tolerated dose (MTD) is
determined. The MTD is defined as the dose preceding that at which at least 2 of 3 patients
experience dose limiting toxicities. Patients are followed for 100 days.
PROJECTED ACCRUAL: A maximum of 37 patients will be accrued for this study.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum Tolerated Dose (MTD) of T-cells photochemically treated with psoralen and ultraviolet A
MTD defined as dose preceding that at which at least 2 of 3 patients experience dose limiting toxicities. Patients followed for 100 days.
James Gajewski, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
|University of Texas - MD Anderson Cancer Center||Houston, Texas 77030-4009|
|University of Illinois at Chicago||Chicago, Illinois 60612|
|Washington University Barnard Cancer Center||Saint Louis, Missouri 63110|