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

Status Completed

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00336843
Study type	Interventional
Source	Asan Medical Center
Contact
Status	Completed
Phase	Phase 2
Start date	November 2005
Completion date	May 2010

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