Skip to main content
OpenTrials
Completed

NCT Number: NCT00147121

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Lymphoma, B-Cell Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

20 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Nagoya Medical Center, Nagoya,Naka-ku,Sannomaru,4-1-1, Aich, Japan

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rituximab + Standard CHOP

Drug

Rituximab + Standard CHOP

Rituximab + Bi-weekly CHOP

Drug

Rituximab + Bi-weekly CHOP

Primary outcomes

  1. CR rate (phase II)

    Time frame: during the study conduct

  2. PFS (phase III)

    Time frame: during the study conduct

Secondary outcomes

  1. ORR, PFS, OS, Safety (phase II)

    Time frame: during the study conduct

  2. OS, Safety (phase III)

    Time frame: during the study conduct

Sponsors and collaborators

Lead sponsor

Haruhiko Fukuda

Other

Collaborators

  • Ministry of Health, Labour and Welfare, Japan

Registry information

Official study 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)

Important dates

Study start
2002
Primary completion
2010
Study completion
2010
First posted
Sep 7, 2005
Registry last updated
Sep 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.