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

Asan Medical Center

Status and phase: Completed; Phase 2

Conditions: Non-Hodgkin's Lymphoma

Treatments: Drug: Zevalin-BuCyE

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00336843

AMC 2005-276

Details and patient eligibility

About

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.

Full 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

Enrollment: 19 patients

Sex: All

Ages: Under 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically confirmed B-cell NHL in chemotherapy-sensitive relapse, in partial response to 1st line chemotherapy, or in complete response after 1st line chemotherapy with high IPI score at diagnosis
• Age < 65 years old
• WHO performance status (PS) of 0-2
• ANC > 1,500/mm3, platelet > 100,000/mm3
• Cr < 2.0 mg% or Ccr > 50 mL/min
• Transaminase < 3X upper normal value
• Bilirubin < 2 mg/dL
• Life expectancy of at least 3 months
• Written informed consent
• Optimal harvest of autologous stem cells (CD34+ cells > 5 million/kg plus 2 million/kg for back-up)

Exclusion criteria

• Prior hematopoietic stem cell transplantation
• Prior RIT
• Prior external radiation to > 25% of active bone marrow
• CNS involvement of non-Hodgkin's lymphoma
• Serious comorbid diseases
• HIV or HTLV-1 associated malignancy
• History of other malignant disease in the previous 5 years, except squamous cell or basal cell carcinoma of skin or stage I uterine cervical carcinoma or cervical carcinoma in situ
• Known hypersensitivity to murine antibodies/proteins
• Pregnant or breast feeding female patients, adults without effective contraception up to 12 months after RIT
• Persistent toxic side effects from prior therapy
• Prior biologic or immunotherapy less than 4 weeks prior to entry on this study
• Investigational drugs less than 4 weeks prior to entry on this study

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 1 patient group

Zevalin-BuCyE

Experimental group

Description:

histologically confirmed, relapsed or refractory CD20 positive B-cell NHL including diffuse large B-cell, follicular, mantle cell, and Burkitt lymphomas.

Treatment:

Drug: Zevalin-BuCyE