A Phase II Trial of High-dose 90Y-Ibritumomab Tiuxetan (Anti-CD20) Followed by Fludarabine and Low-dose Total Body Irradiation and HLA-matched Allogeneic Hematopoietic Transplantation for Patients With Relapsed or Refractory Aggressive B-cell Lymphoma
I. To assess the safety and efficacy of 1.5 mCi/kg (max 120 mCi) 90Y-Ibritumomab tiuxetan
(yttrium Y 90 ibritumomab tiuxetan) (anti-CD20) combined with fludarabine (fludarabine
phosphate) (30 mg/m^2 x 3) and 2 Gy total body irradiation followed by human leukocyte
antigens (HLA) matched allogeneic hematopoietic transplantation for patients with relapsed
or refractory aggressive B-cell lymphoma.
Patients receive a dosimetry test dose of indium In 111 ibritumomab tiuxetan intravenously
(IV) within four weeks prior to transplant and then receive a therapy-dose of high-dose
yttrium Y 90 ibritumomab tiuxetan IV on day -14 prior to transplant. Both ibritumomab
tiuxetan infusions may be preceded by rituximab IV, depending on results of blood tests to
determine rituximab concentration. Patients receive fludarabine phosphate IV on days -4 to
-2 and undergo TBI followed by allogeneic PBSCT on day 0. Patients also receive cyclosporine
orally (PO) twice daily (BID) on days -3 to 56 with taper to day 180 (related donor) or -3
to 100 with taper over 11 weeks (unrelated donor) and mycophenolate mofetil PO BID on days
0-27 (related donor) or PO thrice daily (TID) on days 0-40 with taper to day 96 (unrelated
After completion of study treatment and assessments through ~day 100 following transplant,
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
Progression-free survival (PFS)
Based on a one-sample chi-square test with one-sided significance level of five percent. This study will be deemed successful if the 1 year PFS of this highest-risk group of patients is 54% or greater.
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Food and Drug Administration
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