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

September 20, 2016 updated by: Haruhiko Fukuda

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)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Aich
      • Nagoya,Naka-ku,Sannomaru,4-1-1, Aich, Japan, 460-0001
        • Nagoya Medical Center
    • Aichi
      • Aichi-gun,Nagakute,Yazako,Karimata,21, Aichi, Japan, 480-1195
        • Aichi Medical University
      • Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi, Japan, 464-8681
        • Aichi Cancer Center Hospital
      • Nagoya,Mizuho-ku,Mizuho-cho,Kawasumi,1, Aichi, Japan, 467-8601
        • Nagoya City University Hospital
      • Nagoya,Showa-ku, Tsurumai-cho,65, Aichi, Japan, 466-8550
        • Nagoya University School of Medicine
      • Nagoya,Showa-ku,Myoken-cho,2-9, Aichi, Japan, 466-8650
        • Nagoya Daini Red Cross Hospital
    • Akita
      • Akita,Hondo,1-1-1, Akita, Japan, 010-8543
        • Akita University School of Medicine
    • Chiba
      • Chiba,Chuo-ku,Nitona-cho,666-2, Chiba, Japan, 260-8717
        • Chiba Cancer Center Hospital
      • Kashiwa,Kashiwanoha,6-5-1, Chiba, Japan, 277-8577
        • National Cancer Center Hospital East
    • Ehime
      • Shitsukawa,Toon, Ehime, Japan, 791-0295
        • Ehime University Hospital
    • Fukui
      • Yoshida-gun,Matsuoka,Shimoaizuki,23-3, Fukui, Japan, 910-1193
        • University of Fukui Hospital
    • Fukuoka
      • Fukuoka,Jonan-ku,Nanakuma,7-45-1, Fukuoka, Japan, 814-0180
        • School of Medicine,Fukuoka University
      • Fukuoka,Minami-ku,Notame,3-1-1, Fukuoka, Japan, 811-1395
        • National Kyushu Cancer Center
      • FukuokaChuo-ku,Jigyohama,1-8-1, Fukuoka, Japan, 810-0065
        • National Hospital Organization Kyusyu Medical Center
      • Kitakyushu,Yahatanishi-ku,Iseigaoka,1-1, Fukuoka, Japan, 807-0804
        • University of Occupational and Environmental Health
    • Fukushima
      • Kohriyama,Nishinouchi,2-5-20, Fukushima, Japan, 963-8022
        • Ohta Nishinouchi Hospital
    • Gunma
      • Maebashi,Showa,3-39-15, Gunma, Japan, 371-8511
        • Gunma University
    • Hokkaido
      • Sapporo,Shiroishi-ku,Higashi-sapporo,6-5-1, Hokkaido, Japan, 003-0006
        • Sapporo Hokuyu Hospital
      • Sapporo,Shiroishi-ku,Kikusui,4-2-3-54, Hokkaido, Japan, 003-0804
        • National Hospital Organization Hokkaido Cancer Center
    • Ishikawa
      • Kahoku-gun,Uchinada-machi,Daigaku,1-1, Ishikawa, Japan, 920-0265
        • Kanazawa Medical University
    • Kagoshima
      • Kagoshima,Kamoikeshinmachi,11-23, Kagoshima, Japan, 890-0064
        • Imamura Bun-in Hospital
      • Kagoshima,Sakuragaoka,8-35-1, Kagoshima, Japan, 890-8520
        • Kagoshima University,Faculty of Medicine
    • Kanagawa
      • Isehara,Shimokasuya,143, Kanagawa, Japan, 259-1193
        • Tokai University School of Medicine
      • Yokohama,Asahi-ku,Yasashi-cho,1197-1, Kanagawa, Japan, 241-0811
        • St.Marianna University School of Medicine,Yokohama City Seibu Hospital
    • Kumamoto
      • Kumamoto,Honjo,1-1-1, Kumamoto, Japan, 860-8556
        • Kumamoto University Medical School
      • Kumamoto,Ninomaru,1-5, Kumamoto, Japan, 860-0008
        • Nho Kumamoto Medical Center
    • Kyoto
      • Kyoto,Kamigyo-ku,Kawaramachi-Hirokoji,465, Kyoto, Japan, 602-0841
        • Kyoto Prefectural University of Medicine
    • Mie
      • Tsu,Edobashi,2-174, Mie, Japan, 514-8507
        • Mie University School of Medicine
    • Miyagi
      • Sendai,Aoba-ku,Seiryo-machi,1-1, Miyagi, Japan, 980-8574
        • Tohoku University Hospital
    • Nagasaki
      • Nagasaki,Sakamoto,1-7-1, Nagasaki, Japan, 852-8501
        • Nagasaki University Hospital
      • Oomura,Kubara,2-1001-1, Nagasaki, Japan, 856-8562
        • Nagasaki Medical Center
      • Sasebo,Hirasemachi,9-3, Nagasaki, Japan, 857-8511
        • Sasebo City General Hospital
    • Niigata
      • Niigata,Kawagishi-cho,2-15-3, Niigata, Japan, 951-8566
        • Niigata Cancer Center Hospital
    • Oita
      • Oita,Bunyo,476, Oita, Japan, 870-8511
        • Oita Prefectural Hospital
    • Okinawa
      • Nakagami,Nishihara,Uehara,207, Okinawa, Japan, 903-0125
        • Faculty of Medicine,University of Ryukyus
    • Saga
      • Saga,Nabeshima,5-1-1, Saga, Japan, 849-8501
        • Faculty of Medicine, Saga University
    • Saitama
      • Kita-adachi,Ina,Komuro,818, Saitama, Japan, 362-0806
        • Saitama Cancer Center
    • Shiga
      • Moriyama,Moriyama,5-4-30, Shiga, Japan, 524-8524
        • Shiga Medical Center for Adults
    • Shizuoka
      • Hamamatsu,Handayama,1-20-1, Shizuoka, Japan, 431-3192
        • Hamamatsu University School of Medicine
    • Tokyo
      • Bunkyo-ku,Honkomagome,3-18-22, Tokyo, Japan, 113-8677
        • Tokyo Metropolitan Komagome Hospital
      • Chuo-kum,Tsukiji, 5-1-1, Tokyo, Japan, 104-0045
        • National Cancer Center Hospital
      • Komae,Izumihoncho,4-11-1, Tokyo, Japan, 201-8601
        • Jikei University,Daisan Hospital
      • Minato-ku,Nishishinbashi,3-25-8, Tokyo, Japan, 105-8461
        • Jikei University Hospital
      • Mitaka,Shinkawa,6-20-2, Tokyo, Japan, 181-8611
        • Kyorin University School of Medicine
      • Shinjuku-ku,Nishi-shinjuku,6-7-1, Tokyo, Japan, 160-0023
        • Tokyo Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 69 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 1
Rituximab+Standard CHOP
Drug: Rituximab + Standard CHOP
Rituximab + Standard CHOP
EXPERIMENTAL: 2
Rituximab+bi-Weekly CHOP
Drug: Rituximab + Bi-weekly CHOP
Rituximab + Bi-weekly CHOP

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Haruhiko Fukuda

Collaborators

Ministry of Health, Labour and Welfare, Japan

Investigators

  • Study Chair: Kensei Tobinai, M.D.,Ph.D., National Cancer Center Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2002

Primary Completion (ACTUAL)

February 1, 2010

Study Completion (ACTUAL)

February 1, 2010

Study Registration Dates

First Submitted

September 5, 2005

First Submitted That Met QC Criteria

September 5, 2005

First Posted (ESTIMATE)

September 7, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

September 22, 2016

Last Update Submitted That Met QC Criteria

September 20, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JCOG0203
  • C000000033

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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