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

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)

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00147121

Enrollment

300

Registered

2005-09-07

Start date

2002-09-30

Completion date

2010-02-28

Last updated

2016-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoma, B-Cell

Keywords

Rituximab, CHOP, Bi-weekly, low-grade B-cell lymphoma, advanced stage, follicular lymphoma, G-CSF, Untreated stage III/IV low-grade B-cell lymphoma

Brief summary

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

Detailed 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.

Interventions

DRUGRituximab + Standard CHOP

Rituximab + Standard CHOP

DRUGRituximab + Bi-weekly CHOP

Rituximab + Bi-weekly CHOP

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 69 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
CR rate (phase II)	during the study conduct
PFS (phase III)	during the study conduct

Secondary

Measure	Time frame
ORR, PFS, OS, Safety (phase II)	during the study conduct
OS, Safety (phase III)	during the study conduct

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026