Donor Lymphocyte Infusion for the Treatment Of Malignancy After Hematopoietic Cell Transplantation Using Nonmyeloablative Conditioning - A Multi-Center Trial
I. To assess the safety of donor lymphocyte infusion (DLI) as adoptive immunotherapy for
persistent or relapsed malignant diseases in patients after related or unrelated
I. To determine disease response, progression free and overall survival, chimerism, grade of
graft-versus-host disease (GVHD), and infections.
Patients receive unirradiated DLI over 15-30 minutes on day 0. Patients undergo restaging on
day 28 and may receive a second DLI after at least 4 weeks if no significant GVHD develops
and disease status worsens or after at least 8 weeks if disease status is unchanged and
persistent donor T-cells are documented.
After completion of study treatment, patients are followed up periodically.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety of DLI following a non-myeloablative transplant, defined as incidence of grade IV acute GVHD
Following the Fred Hutchinson Cancer Research Center (FHCRC) guidelines for serious adverse event (SAE) reporting.
At day 84 and 1 year
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Federal Government
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium||Seattle, Washington 98109|
|OHSU Knight Cancer Institute||Portland, Oregon 97239|
|Froedtert Memorial Lutheran Hospital, Medical College of Wisconsin||Milwaukee, Wisconsin 53226|
|Veterans Administration Center-Seattle||Seattle, Washington 98108|