Zevalin Plus BuCyE High-dose Therapy in B-cell Non-Hodgkin's Lymphoma
- Conditions
- Non-Hodgkin's Lymphoma
- Interventions
- Drug: Zevalin-BuCyE
- Registration Number
- NCT00336843
- Lead Sponsor
- Asan Medical Center
- Brief 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 19
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Zevalin-BuCyE Zevalin-BuCyE histologically confirmed, relapsed or refractory CD20 positive B-cell NHL including diffuse large B-cell, follicular, mantle cell, and Burkitt lymphomas.
- Primary Outcome Measures
Name Time Method Event-free survival the time from stem cell infusion to failure or death from any cause Three year event-free survival rate would be reported.
- Secondary Outcome Measures
Name Time Method Overall survival from stem cell infusion to death of any cause or last follow-up Three year overall survival would be reported.
Toxicity of the treatment combination any toxicity due to study treatment during study period 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.
Trial Locations
- Locations (1)
Asan Medical Center, Departement of Internal Medicine, Division of Oncology
🇰🇷Seoul, Korea, Republic of