Overview
Rituximab+Standard CHOP vs Rituximab+Bi-weekly CHOP for Untreated Stage III/IV Low-grade B-cell Lymphoma (JCOG0203)
Status:
Completed
Completed
Trial end date:
2010-02-01
2010-02-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
To establish standard therapy for patients with advanced-stage low grade B-cell lymphomaPhase:
Phase 2/Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Haruhiko FukudaCollaborator:
Ministry of Health, Labour and Welfare, JapanTreatments:
Rituximab
Criteria
Inclusion Criteria:1. Histological confirmed, low-grade B-cell lymphoma except mantle cell lymphoma and
histologic transformation to DLBCL
2. CD20-positive
3. Ann Arbor CS III or IV
4. Lymphoma cell count in PB≦10,000/mm3
5. 20<=age<=69
6. ECOG PS 0-2
7. Bidimensionally measurable disease >1.5cm in a single dimension by CT scans
8. No prior chemotherapy, radiotherapy, interferon-alfa, or antibody therapy
9. Normal BM, hepatic, renal, cardiac, and pulmonary function
10. Written informed consent
Exclusion Criteria:
1. CNS involvement
2. Glaucoma
3. DM treated by insulin
4. Uncontrollable HT
5. AP, AMI
6. Positive HBs antigen
7. seropositive to HCV
8. seropositive to HIV
9. Interstitial pneumonitis, pulmonary fibrosis, or emphysema
10. Severe infection
11. Liver cirrhosis
12. Double cancer
13. Pregnant or lactating
14. Patients who desire auto PBST after CR
15. Patients treated with major tranquilizer or antidepressant