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
OBJECTIVES:
Primary
- 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.
Secondary
- Determine the extent, degree, and duration of donor chimerism in patients treated with
this regimen.
- 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
1-12.
NOTE: *DLI are not administered on days 5 or 10 if grade 3 or 4 graft-versus-host disease is
present
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.
Interventional
Primary Purpose: Treatment
Feasibility
No
William I. Bensinger, MD
Principal Investigator
Fred Hutchinson Cancer Research Center
United States: Federal Government
1838.00
NCT00248430
August 2003
July 2007
Name | Location |
---|---|
Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
Seattle Cancer Care Alliance | Seattle, Washington 98109 |