Cyclophosphamide Plus Transplantation of Partially HLA-Mismatched (Haploidentical), CD8+ T Cell-Depleted Peripheral Blood Cells (PBCs) for Patients With Myelodysplastic (MDS) or Myeloproliferative Disorders (MPD)
- Determine the maximum tolerated dose of allogeneic CD8-positive T-cell-depleted,
haploidentical donor lymphocytes when given after cyclophosphamide in patients with
myelodysplastic syndromes or myeloproliferative disorders.
OUTLINE: Patients receive cyclophosphamide on days 1 and 2. Patients then undergo infusion
of allogeneic T-cell depleted donor lymphocytes on day 3.
Cohorts of patients receive escalating doses of CD8-positive T-cell-depleted haploidentical
donor lymphocytes until the maximum tolerated dose is determined.
PROJECTED ACCRUAL: A total of 44 patients will be accrued for this study.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose of CD8-positive T-cell-depleted haploidentical donor lymphocytes
Yvette L. Kasamon, MD
Sidney Kimmel Comprehensive Cancer Center
United States: Food and Drug Administration
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|