Non-Hodgkin's Lymphoma
Conditions
Keywords
Zevalin, B-cell non-Hodgkin's lymphoma, autologous stem cell transplantation, BuCyE regimen
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
Interventions
DRUGZevalin-BuCyE
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
Sponsors
Schering-Plough
Asan Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 64 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
South Korea
Outcome results
None listed