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

Sponsor
Ruijin Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT01852435
Collaborator
(none)
648
Enrollment
12
Locations
3
Arms
57.1
Duration (Months)
54
Patients Per Site
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
648 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Study Start Date :
May 1, 2013
Anticipated Primary Completion Date :
Dec 1, 2017
Anticipated Study Completion Date :
Feb 1, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. progression free survival [2 year]

Secondary Outcome Measures

  1. overall survival [2 year]

  2. Response rate [Every 4 cycles during treatment and then every 3 months for 2 years]

    21 days as one cycle

  3. Safety as assessed using the CTCAE [Days 1 of each course and then every 3 months for 2 years]

    21 days as one cycle

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 >2ULN,AKP or bilirubin >1.5ULN

  • Creatinine>1.5*ULN

  1. Not able to comply to the protocol for mental or other unknown reasons

  2. Pregnant or lactation

  3. Active liver or biliary disease

  4. 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.

  5. HIV infection

Contacts and Locations

Locations

Site City State Country Postal Code
1 Southwest Hospital Chongqing Chongqing China
2 Fujian Medical University Union Hospital Fuzhou Fujian China
3 Guangdong General Hospital Guangzhou Guangdong China
4 Henan Cancer Hospital Zhengzhou Henan China
5 Tongji Hospital Wuhan Hubei China
6 Jiangsu Province Hospital Nanjing Jiangsu China
7 The first hospital of China medical university Shenyang Liaoning China
8 Shanxi Provincial Tumor Hospital Taiyuan Shanxi China
9 West China Hospital Chengdu Sichuan China
10 Institute of Hematology and Blood Diseases Hospital Tianjin Tianjin China
11 Shandong Provincal Hospital Jinan China
12 Shanghai Ruijin Hospital Shanghai China 200025

Sponsors and Collaborators

  • Ruijin Hospital

Investigators

  • Principal Investigator: Weili Zhao, MD, PhD,

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zhao Weili, Professor, Ruijin Hospital
ClinicalTrials.gov Identifier:
NCT01852435
Other Study ID Numbers:
  • NHL-001
First Posted:
May 13, 2013
Last Update Posted:
Nov 14, 2017
Last Verified:
Nov 1, 2017
Keywords provided by Zhao Weili, Professor, Ruijin Hospital
diffuse large B-cell lymphoma
follicular lymphoma grade 3B
Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Non-Hodgkin

Study Results

No Results Posted as of Nov 14, 2017