Status:
COMPLETED
Zevalin Plus BuCyE High-dose Therapy in B-cell Non-Hodgkin's Lymphoma
Lead Sponsor:
Asan Medical Center
Collaborating Sponsors:
Schering-Plough
Conditions:
Non-Hodgkin's Lymphoma
Eligibility:
All Genders
Up to 64 years
Phase:
PHASE2
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. Investi...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00336843
Start Date
November 1 2005
End Date
May 1 2010
Last Update
February 17 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Asan Medical Center, Departement of Internal Medicine, Division of Oncology
Seoul, South Korea, 138-736