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

Asan Medical Center19 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Non-Hodgkin's Lymphoma

Interventions

Zevalin-BuCyEDRUG

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

Eligibility

Sex: ALLMax age: 64 Years

Medical Language ↔ Plain English

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

Locations (1)

Asan Medical Center, Departement of Internal Medicine, Division of Oncology

Seoul, South Korea

Outcomes

Primary Outcomes

Event-free survival

Three year event-free survival rate would be reported.

Time frame: the time from stem cell infusion to failure or death from any cause

Secondary Outcomes

Overall survival

Three year overall survival would be reported.

Time frame: from stem cell infusion to death of any cause or last follow-up

Toxicity of the treatment combination

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.

Time frame: any toxicity due to study treatment during study period

Data from ClinicalTrials.gov

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