This trial is active, not recruiting.

Condition lymphoma, b-cell
Treatments rituximab + standard chop, rituximab + bi-weekly chop
Phase phase 2/phase 3
Sponsor Japan Clinical Oncology Group
Collaborator Ministry of Health, Labour and Welfare, Japan
Start date September 2002
End date February 2010
Trial size 300 participants
Trial identifier NCT00147121, C000000033, JCOG0203


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(Active Comparator)
Rituximab+Standard CHOP
rituximab + standard chop
Rituximab + Standard CHOP
Rituximab+bi-Weekly CHOP
rituximab + bi-weekly chop
Rituximab + Bi-weekly CHOP

Primary Outcomes

CR rate (phase II)
time frame: during the study conduct
PFS (phase III)
time frame: during the study conduct

Secondary Outcomes

ORR, PFS, OS, Safety (phase II)
time frame: during the study conduct
OS, Safety (phase III)
time frame: during the study conduct

Eligibility Criteria

Male or female participants from 20 years up to 69 years old.

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

Additional Information

Official title Rituximab + Standard CHOP (R・S-CHOP) vs Rituximab+ bi-Weekly CHOP (R・Bi-CHOP) RCT(Phase II/III) for Stage III/IV Low-Grade B-Cell Lymphoma (LowBNHL-RS/BiCHOP-P2/3) (JCOG0203)
Description Since currently there is no standard therapy for untreated advanced-stage low-grade B-cell lymphoma, Phase 2/3 study was planned. Comparison(s): An intensified bi-weekly version by shortening the intervals of both rituximab and CHOP therapies using G-CSF, compared to the tri-weekly R-CHOP regimen.
Trial information was received from ClinicalTrials.gov and was last updated in February 2009.
Information provided to ClinicalTrials.gov by Japan Clinical Oncology Group.