R-CEOP-90/R-CEOP-70 Versus R-CHOP-50 in the Treatment of Diffuse Large B-cell Lymphoma and Follicular Lymphoma Grade 3B

November 10, 2017 updated by: Zhao Weili, Ruijin Hospital

A Multi-center, Prospective, Randomized Phase III Study of the Safety and Efficacy of R-CEOP-90/R-CEOP-70 Versus R-CHOP-50 in the Treatment of Diffuse Large B-cell Lymphoma and Follicular Lymphoma Grade 3B

The main purpose of this study is to evaluate the safety and efficacy of R-CEOP-90/R-CEOP-70 Versus R-CHOP-50 in the Treatment of Diffuse Large B-cell lymphoma and Follicular Lymphoma Grade 3B patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The study aims to evaluate the safety and efficacy of R-CEOP-90/R-CEOP-70 Versus R-CHOP-50 in the Treatment of Diffuse Large B-cell lymphoma and Follicular Lymphoma Grade 3B patients.

Study Type

Interventional

Enrollment (Actual)

648

Phase

  • 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

  • China
      • Jinan, China
        • Shandong Provincal Hospital
      • Shanghai, China, 200025
        • Shanghai Ruijin Hospital
    • Chongqing
      • Chongqing, Chongqing, China
        • Southwest Hospital
    • Fujian
      • Fuzhou, Fujian, China
        • Fujian Medical University Union Hospital
    • Guangdong
      • Guangzhou, Guangdong, China
        • Guangdong General Hospital
    • Henan
      • Zhengzhou, Henan, China
        • Henan Cancer Hospital
    • Hubei
      • Wuhan, Hubei, China
        • Tongji Hospital
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Jiangsu Province Hospital
    • Liaoning
      • Shenyang, Liaoning, China
        • The First Hospital of China Medical University
    • Shanxi
      • Taiyuan, Shanxi, China
        • Shanxi Provincial Tumor Hospital
    • Sichuan
      • Chengdu, Sichuan, China
        • West China Hospital
    • Tianjin
      • Tianjin, Tianjin, China
        • Institute of Hematology and Blood Diseases Hospital

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

16 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Histologically confirmed de novo diffuse large B-cell lymphoma or follicular lymphoma grade 3B
  2. Age>=16 y.o.,<=80 y.o.
  3. ECOG < 3
  4. No past history of malignancy
  5. Radiologically measurable disease, CT imaging in screening showing 2 or more clearly demarcated lesions with a largest diameter > 1.5 cm, or 1 clearly demarcated lesion with a largest diameter > 2.0 cm.
  6. Life expectancy>6 months
  7. Informed consented

Exclusion Criteria:

  1. Chemotherapy before
  2. Bone marrow transplantation before
  3. History of malignancy
  4. Active infectious disease requiring general antibiotics, anti-fungal or anti-virus therapy
  5. Uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease
  6. Primary cutaneous, CNS, mediastinal DLBCL
  7. LVEF≤50%
  8. Other uncontrollable medical condition that may that may interfere the participation of the study

  9. Lab at enrollment(unless caused by lymphoma)

    • Neutrophile<1.5*10^9/L
    • Platelet<80*10^9/L
    • Hemoglobulin<100g/L
    • ALT or AST >2*ULN,AKP or bilirubin >1.5*ULN
    • Creatinine>1.5*ULN
  10. Not able to comply to the protocol for mental or other unknown reasons
  11. Pregnant or lactation
  12. Active liver or biliary disease
  13. If HbsAg positive, should check HBV DNA, DNA positive patients cannot be enrolled. If HBsAg negative but HBcAb positive (whatever HBsAb status), should check HBV DNA,DNA positive patients cannot be enrolled.
  14. HIV infection

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: R-CHOP-50
R-CHOP-50 (Rituximab 375 mg/m2 d1+Cyclophosphomide 750mg/m2 d2+Adriamycin 50mg/m2 d2+vincristine 1.4mg/m2 d2+Prednisone 60 mg/m2 d2-6) every 21 days for 6 cycles, followed by Rituximab 375 mg/m2 every 21 days for 2 cycles.
Drug: R-CHOP-50
Experimental: R-CEOP-70
R-CEOP-70 (Rituximab 375 mg/m2 d1+Cyclophosphomide 750mg/m2 d2+Adriamycin 70mg/m2 d2+vincristine 1.4mg/m2 d2+Prednisone 60 mg/m2 d2-6) every 21 days for 6 cycles, followed by Rituximab 375 mg/m2 every 21 days for 2 cycles.
Drug: R-CEOP-70
Experimental: R-CEOP-90
R-CEOP-90 (Rituximab 375 mg/m2 d1+Cyclophosphomide 750mg/m2 d2+Adriamycin 90mg/m2 d2+vincristine 1.4mg/m2 d2+Prednisone 60 mg/m2 d2-6) every 21 days for 6 cycles, followed by Rituximab 375 mg/m2 every 21 days for 2 cycles.
Drug: R-CEOP-90

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
progression free survival
Time Frame: 2 year
2 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival
Time Frame: 2 year
2 year
Response rate
Time Frame: Every 4 cycles during treatment and then every 3 months for 2 years
21 days as one cycle
Every 4 cycles during treatment and then every 3 months for 2 years
Safety as assessed using the CTCAE
Time Frame: Days 1 of each course and then every 3 months for 2 years
21 days as one cycle
Days 1 of each course and then every 3 months for 2 years

Collaborators and Investigators

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

Sponsor

Ruijin Hospital

Investigators

  • Principal Investigator: Weili Zhao, MD, PhD

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

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

May 1, 2013

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

February 1, 2018

Study Registration Dates

First Submitted

May 8, 2013

First Submitted That Met QC Criteria

May 10, 2013

First Posted (Estimate)

May 13, 2013

Study Record Updates

Last Update Posted (Actual)

November 14, 2017

Last Update Submitted That Met QC Criteria

November 10, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NHL-001

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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