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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

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ClinicalTrials.gov Identifier: NCT01852435
Recruitment Status : Active, not recruiting
First Posted : May 13, 2013
Last Update Posted : November 14, 2017
Sponsor:
Information provided by (Responsible Party):
Zhao Weili, Ruijin Hospital

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
Diffuse Large B-cell Lymphoma Follicular Lymphoma Grade 3B Drug: R-CEOP-70 Drug: R-CEOP-90 Drug: R-CHOP-50 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.

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Study Type : Interventional  (Clinical Trial)
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 2013
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : February 2018


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



Primary Outcome Measures :
  1. progression free survival [ Time Frame: 2 year ]

Secondary Outcome Measures :
  1. overall survival [ Time Frame: 2 year ]
  2. Response rate [ Time Frame: 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 [ Time Frame: Days 1 of each course and then every 3 months for 2 years ]
    21 days as one cycle



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Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01852435


Locations
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China, Chongqing
Southwest Hospital
Chongqing, Chongqing, China
China, Fujian
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
China, Guangdong
Guangdong General Hospital
Guangzhou, Guangdong, China
China, Henan
Henan Cancer Hospital
Zhengzhou, Henan, China
China, Hubei
Tongji Hospital
Wuhan, Hubei, China
China, Jiangsu
Jiangsu Province Hospital
Nanjing, Jiangsu, China
China, Liaoning
The first hospital of China medical university
Shenyang, Liaoning, China
China, Shanxi
Shanxi Provincial Tumor Hospital
Taiyuan, Shanxi, China
China, Sichuan
West China Hospital
Chengdu, Sichuan, China
China, Tianjin
Institute of Hematology and Blood Diseases Hospital
Tianjin, Tianjin, China
China
Shandong Provincal Hospital
Jinan, China
Shanghai Ruijin Hospital
Shanghai, China, 200025
Sponsors and Collaborators
Ruijin Hospital
Investigators
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Principal Investigator: Weili Zhao, MD, PhD

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Zhao Weili, Professor, Ruijin Hospital
ClinicalTrials.gov Identifier: NCT01852435     History of Changes
Other Study ID Numbers: NHL-001
First Posted: May 13, 2013    Key Record Dates
Last Update Posted: November 14, 2017
Last Verified: November 2017
Keywords provided by Zhao Weili, Ruijin Hospital:
diffuse large B-cell lymphoma
follicular lymphoma grade 3B
Additional relevant MeSH terms:
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Lymphoma, Follicular
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Prednisone
Cyclophosphamide
Vincristine
Rituximab
Doxorubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal