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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Haruhiko Fukuda

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ministry of Health, Labour and Welfare, Japan

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2002

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2010

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 5, 2005

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 5, 2005

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 7, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 22, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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