A Phase II Trial Evaluating the Safety and Efficacy of Non-myeloablative 90Y-Ibritumomab Tiuxetan (Anti-CD20) Antibody With Fludarabine, Low-Dose Total Body Irradiation (TBI) and HLA Matched Allogeneic Transplantation for Relapsed B-cell Lymphoma
I. To assess the feasibility, safety, and potential efficacy of treating patients with
B-Cell non-Hodgkin lymphoma (NHL) with 90Y-ibritumomab tiuxetan, combined with HLA-matched
related or unrelated donor hematopoietic cell transplantation.
OUTLINE: Patients receive rituximab intravenously (IV) followed by, no more than 4 hours
later, indium In 111 ibritumomab tiuxetan (for imaging) IV over 10 minutes on day -21.
Patients undergo gamma camera imaging on day -19. Patients receive rituximab IV followed by,
no more than 4 hours later, yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day -14.
Patients also receive fludarabine phosphate IV over 30-60 minutes on days -7 to -5 and
undergo low-dose total-body irradiation (TBI) on day 0. After TBI, patients undergo
allogeneic peripheral blood stem cell transplantation (PBSCT) on day 0. Patients who undergo
PBSCT from a related donor receive oral cyclosporine twice daily on days -3 to 56 followed
by a taper to day 180 in the absence of graft-versus-host disease (GVHD). These patients
also receive oral mycophenolate mofetil twice daily on days 0 to 27. Patients who undergo
PBSCT from an unrelated donor receive oral cyclosporine twice daily on days -3 to 100
followed by a taper over 11 weeks in the absence of GVHD. These patients also receive oral
mycophenolate mofetil three times daily on days 0 to 40 followed by a taper to day 96.
After completion of study treatment, patients are followed up at 1, 3, 6, and 12 months, and
then annually thereafter.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Treatment related mortality (TRM)
At day +100
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Institutional Review Board
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium||Seattle, Washington 98109|