Zevalin Plus BuCyE High-dose Therapy in B-cell Non-Hodgkin's Lymphoma
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Event-free survival [ Time Frame: the time from stem cell infusion to failure or death from any cause ] [ Designated as safety issue: No ]Three year event-free survival rate would be reported.
- Overall survival [ Time Frame: from stem cell infusion to death of any cause or last follow-up ] [ Designated as safety issue: No ]Three year overall survival would be reported.
- Toxicity of the treatment combination [ Time Frame: any toxicity due to study treatment during study period ] [ Designated as safety issue: Yes ]Adverse events would be assessed and graded according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE), version 3.0. And the frequency of each grade would be reported as case number and proportion.
|Study Start Date:||November 2005|
|Study Completion Date:||May 2010|
|Primary Completion Date:||February 2009 (Final data collection date for primary outcome measure)|
histologically confirmed, relapsed or refractory CD20 positive B-cell NHL including diffuse large B-cell, follicular, mantle cell, and Burkitt lymphomas.
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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00336843
|Korea, Republic of|
|Asan Medical Center, Departement of Internal Medicine, Division of Oncology|
|Seoul, Korea, Republic of, 138-736|
|Principal Investigator:||Cheolwon Suh, MD, PhD||Asan Medical Center|