Rituximab+Standard CHOP vs Rituximab+Bi-weekly CHOP for Untreated Stage III/IV Low-grade B-cell Lymphoma (JCOG0203)

• Status: Completed
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

Summary

To establish standard therapy for patients with advanced-stage low grade B-cell lymphoma

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Haruhiko Fukuda
• Collaborator: Ministry of Health, Labour and Welfare, Japan
• Treatments: 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