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
N/A
64 Years
Both
Non-Hodgkin's Lymphoma
Trial Information
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
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
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Event-free survival
Outcome Description:
Three year event-free survival rate would be reported.
Outcome Time Frame:
the time from stem cell infusion to failure or death from any cause
Safety Issue:
No
Principal Investigator
Cheolwon Suh, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Asan Medical Center
Authority:
Korea: Food and Drug Administration
Study ID:
AMC 2005-276
NCT ID:
NCT00336843
Start Date:
November 2005
Completion Date:
May 2010
Related Keywords:
- Non-Hodgkin's Lymphoma
- Zevalin
- B-cell non-Hodgkin's lymphoma
- autologous stem cell transplantation
- BuCyE regimen
- Lymphoma
- Lymphoma, Non-Hodgkin
- Lymphoma, B-Cell
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