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

Study Overview
=================
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.

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)

Conditions
-----------------
Lymphoma, B-Cell

Intervention / Treatment
-----------------
* Drug: Rituximab + Standard CHOP
* Drug: Rituximab + Bi-weekly CHOP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histological confirmed, low-grade B-cell lymphoma except mantle cell lymphoma and histologic transformation to DLBCL CD20-positive Ann Arbor CS III or IV Lymphoma cell count in PB≦10,000/mm3 20<=age<=69 ECOG PS 0-2 Bidimensionally measurable disease >1.5cm in a single dimension by CT scans No prior chemotherapy, radiotherapy, interferon-alfa, or antibody therapy Normal BM, hepatic, renal, cardiac, and pulmonary function Written informed consent Exclusion Criteria: CNS involvement Glaucoma DM treated by insulin Uncontrollable HT AP, AMI Positive HBs antigen seropositive to HCV seropositive to HIV Interstitial pneumonitis, pulmonary fibrosis, or emphysema Severe infection Liver cirrhosis Double cancer Pregnant or lactating Patients who desire auto PBST after CR Patients treated with major tranquilizer or antidepressant

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 69 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Rituximab+Standard CHOP | Drug: Rituximab + Standard CHOP<br>* Rituximab + Standard CHOP<br>|
| Experimental: 2<br>Rituximab+bi-Weekly CHOP | Drug: Rituximab + Bi-weekly CHOP<br>* Rituximab + Bi-weekly CHOP<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CR rate (phase II) |  | during the study conduct | 
| PFS (phase III) |  | during the study conduct | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR, PFS, OS, Safety (phase II) |  | during the study conduct | 
| OS, Safety (phase III) |  | during the study conduct | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rituximab, CHOP, Bi-weekly, low-grade B-cell lymphoma, advanced stage, follicular lymphoma, G-CSF, Untreated stage III/IV low-grade B-cell lymphoma