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)

UMIN ID: C000000033

Registered date:30/07/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Untreated CD20-positive low-grade B-cell lymphoma at advanced stage
• Date of first enrollment: 2002/09/01
• Target sample size: 300
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Rituximab + Standard CHOP
Rituximab + Bi-weekly CHOP

Outcome(s)

• Primary Outcome: CR rate (phase II), PFS (phase III)
• Secondary Outcome: ORR, PFS, OS, Safety (phase II), OS, Safety (phase III)

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 69years-old
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: Japan Clinical Oncology Group(JCOG)
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare
• Secondary ID(s): NCT00147121