NCT00336843

Zevalin Plus BuCyE High-dose Therapy in B-cell Non-Hodgkin's Lymphoma

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Asan Medical Center · Academic / Other
• Sex: All
• Age: 64 Years
• Healthy volunteers: Not accepted

Summary

In order to improve the clinical result of high-dose chemotherapy and autologous stem cell transplantation for B-cell non-Hodgkin's lymphoma, Zevalin will be added to the conditioning regimen. Investigators expect this radioimmunotherapy of Zevalin plus busulfan, cyclophosphamide and etoposide regimen will improve survival of relapsed or poor-risk B-cell non-Hodgkin's lymphoma.

Detailed description

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. Study objectives: * 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 Treatment: Z-BuCyE Regimen * 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

Conditions

• Non-Hodgkin's Lymphoma

Interventions

Type	Name	Description
DRUG	Zevalin-BuCyE	rituximab (IV, 250 mg/m2 on days -21 and -14) single dose of 90Y-ibritumomab (IV, 0.4 mCi/kg on day -14) Busulfan (IV, 0.8 mg/kg every 6 h from day -7 to day -5) Cyclophosphamide (IV, 50 mg/kg on days -3 and -2) Etoposide (IV, 200 mg/m2 every 12 h on days -5 and -4) Autologous stem cells infusion on day 0

Timeline

• Start date: 2005-11-01
• Primary completion: 2009-02-01
• Completion: 2010-05-01
• First posted: 2006-06-14
• Last updated: 2016-02-17

Locations

1 site across 1 country: South Korea