Overview

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

Status:
Completed
Trial end date:
2010-05-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Asan Medical Center
Collaborator:
Schering-Plough
Treatments:
Antibodies, Monoclonal
Criteria
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