Rituximab + standard CHOP (R S-CHOP) vs Rituximab + bi-weekly CHOP (R Bi-CHOP) RCT(phase II/III) low-grade B-cell lymphoma at advanced stage (LowBNHL-RS/BiCHOP-P2/3) (JCOG0203)

Rituximab + standard CHOP (R S-CHOP) vs Rituximab + bi-weekly CHOP (R Bi-CHOP) RCT(phase II/III) low-grade B-cell lymphoma at advanced stage (LowBNHL-RS/BiCHOP-P2/3) (JCOG0203) - Rituximab + standard CHOP vs Rituximab + bi-weekly CHOP for untreated low-grade B-cell lymphoma at advanced stage (JCOG0203)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-C000000033

Enrollment

300

Registered

2005-07-30

Start date

2002-09-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Untreated CD20-positive low-grade B-cell lymphoma at advanced stage

Interventions

Rituximab + Standard CHOP Rituximab + Bi-weekly CHOP

Eligibility

Sex/Gender

All

Inclusion 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 dimention 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

Exclusion criteria: (1) CNS involvement (2) Glaucoma (3) DM treated by insulin (4) Uncontrolable 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), PFS (phase III)	—

Secondary

Measure	Time frame
ORR, PFS, OS, Safety (phase II), OS, Safety (phase III)	—

Countries

Japan

Contacts

Public ContactTakashi Watanabe, M.D.,Ph.D.

JCOG0203 Coordinating Office Hematology Division, National Cancer Center Hospital

JCOG_sir@ml.jcog.jp

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026