Combining 90Y-ibritumomab Tiuxetan With High-dose Chemotherapy of BuCyE and Autologous Stem Cell Transplantation in Patients With B-cell Non-Hodgkin's Lymphoma - an Open-labeled Phase II Study
Title: Combining 90Y-Ibritumomab tiuxetan (Zevalin) with high-dose chemotherapy of BuCyE and
autologous stem cell transplantation in patients with relapsed, refractory, or high-risk
B-cell non-Hodgkin's lymphoma - an open-labeled phase II study.
Study design: Prospective, multicenter, open-labeled, phase II trial.
- Primary: event-free survival time following autologous stem cell transplantation with
90Y-Ibritumomab tiuxetan and BuCyE high-dose chemotherapy in patients with relapsed,
refractory, or high-risk B-cell non-Hodgkin's lymphoma
- Secondary: overall survival response rate toxicity of the treatment combination
- Day 21: rituximab, 250 mg/m2, I.V.
- Day 14: rituximab, 250 mg/m2, I.V. 90Y-Ibritumomab tiuxetan, 0.4 mCi/kg, I.V.
- Day 7, 6, 5: busulfan 3.2 mg/kg I.V.
- Day 5, 4: etoposide 200 mg/m2 I.V. every 12 hours
- Day 3, 2: Cytoxan 50 mg/kg I.V.
- Day 0: autologous stem cell infusion
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Three year event-free survival rate would be reported.
the time from stem cell infusion to failure or death from any cause
Cheolwon Suh, MD, PhD
Asan Medical Center
Korea: Food and Drug Administration