A Phase I-II Trial of Adoptive Immunotherapy Using Haploidentical, Related Donor-Lymphocyte Infusions and IL-2 After Autologous Stem Cell Transplantation for Advanced Lymphoid Malignancies
- Determine the feasibility and toxicity of haploidentical related donor lymphocyte
infusions (DLI) and interleukin-2, in terms of acute graft-versus-host-disease, graft
failure, and transplant-related mortality, in patients with relapsed advanced lymphoid
malignancies undergoing autologous stem cell transplantation.
- Determine the extent, degree, and duration of donor chimerism in patients treated with
- Determine, preliminarily, activity of haploidentical DLI, as measured by complete
response rate, in these patients.
OUTLINE: This is a pilot study.
Patients receive high-dose melphalan IV over 15-60 minutes on day -2 and undergo autologous
stem cell transplantation on day 0. Patients receive haploidentical related donor lymphocyte
infusions (DLI) IV on days 1, 5*, and 10* and interleukin-2 (IL-2) IV continuously on days
NOTE: *DLI are not administered on days 5 or 10 if grade 3 or 4 graft-versus-host disease is
After completion of study treatment, patients are followed monthly for 3 months and then
every 3-12 months thereafter.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Primary Purpose: Treatment
William I. Bensinger, MD
Fred Hutchinson Cancer Research Center
United States: Federal Government
|Fred Hutchinson Cancer Research Center||Seattle, Washington 98109|
|Seattle Cancer Care Alliance||Seattle, Washington 98109|