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R-CHOP Versus R-CDOP as First-line Treatment for Elderly Patients With Diffuse Large-B-cell Lymphoma

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ClinicalTrials.gov Identifier: NCT02428751
Recruitment Status : Unknown
Verified November 2015 by Wenqi Jiang, Sun Yat-sen University.
Recruitment status was:  Recruiting
First Posted : April 29, 2015
Last Update Posted : November 18, 2015
Sponsor:
Information provided by (Responsible Party):
Wenqi Jiang, Sun Yat-sen University

Brief Summary:
The combination of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP regimen) has been the first-line chemotherapy for elderly patients with diffuse large B-cell lymphoma (DLBCL). The treatment-related toxicities, especially the severe cardiac toxicities induced by anthracycline drugs (doxorubicin), have become a major concern among elderly patients. Pegylated liposomal doxorubicin is a formulation of doxorubicin with a prolonged circulation time and unique toxicity profile. Previous single arm studies of elderly patients with lymphoma used pegylated liposomal doxorubicin instead of traditional doxorubicin in combination with rituximab, cyclophosphamide, vincristine, and prednisone (the novel R-CDOP regimen), and demonstrated better safety profile, including less bone marrow suppression and less cardiac toxicities, while maintaining the efficacy. However, the efficacy and safety of these two regimens (R-CHOP and R-CDOP) have not been head-to-head compared in a randomized study. The aim of this study is to compare the efficacy and safety of R-CDOP (rituximab, cyclophosphamide, pegylated liposomal doxorubicin, vincristine, and prednisone) and R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) in previously untreated elderly patients with DLBCL.

Condition or disease Intervention/treatment Phase
Lymphoma, Large B-Cell, Diffuse Drug: Pegylated liposomal doxorubicin Drug: Doxorubicin Drug: Rituximab Drug: Cyclophophamide Drug: Vincristine Drug: Prednisone Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 216 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Rituximab, Cyclophosphamide, Vincristine, and Prednisone in Combination With Doxorubicin (R-CHOP) Versus in Combination With Pegylated-liposomal Doxorubicin (R-CDOP) as First-line Treatment for Elderly Patients With Diffuse Large-B-cell Lymphoma: a Randomised, Multicentre, Non-inferiority Study
Study Start Date : September 2015
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : May 2020


Arm Intervention/treatment
Active Comparator: R-CHOP
This group received R-CHOP regimen as the first-line chemotherapy. Rituximab, 375mg/m2, iv, d0; Cyclophophamide, 750mg/m2, iv, d1; Doxorubicin, 50mg/m2, iv, d1; Vincristine, 2mg/m2 (max 2mg), iv, d1; Prednisone, 100mg, po, d1-5. Repeat every 21 days for 6-8 cycles or until the criteria of terminating treatment was met.
Drug: Doxorubicin
50 mg/m2, IV (in the vein) on day 1 of each 21 day cycle

Drug: Rituximab
375 mg/m2, IV (in the vein) on day 0 of each 21 day cycle

Drug: Cyclophophamide
750 mg/m2, IV (in the vein) on day 1 of each 21 day cycle

Drug: Vincristine
1.4 mg/m2 (2mg in maxium), IV (in the vein) on day 1 of each 21 day cycle

Drug: Prednisone
100mg/d, PO on day 1-5 of each 21 day cycle

Experimental: R-CDOP
This group received R-CDOP regimen as the first-line chemotherapy. Rituximab, 375mg/m2, iv, d0; Cyclophophamide, 750mg/m2, iv, d1; Pegylated liposomal doxorubicin, 30mg/m2, iv, d1; Vincristine, 2mg/m2 (max 2mg), iv, d1; Prednisone, 100mg, po, d1-5. Repeat every 21 days for 6-8 cycles or until the criteria of terminating treatment was met.
Drug: Pegylated liposomal doxorubicin
30 mg/m2, IV (in the vein) on day 1 of each 21 day cycle

Drug: Rituximab
375 mg/m2, IV (in the vein) on day 0 of each 21 day cycle

Drug: Cyclophophamide
750 mg/m2, IV (in the vein) on day 1 of each 21 day cycle

Drug: Vincristine
1.4 mg/m2 (2mg in maxium), IV (in the vein) on day 1 of each 21 day cycle

Drug: Prednisone
100mg/d, PO on day 1-5 of each 21 day cycle




Primary Outcome Measures :
  1. event-free survival (EFS) [ Time Frame: two year ]
    Defined as time from the date of randomization to the date of disease progression, death due to any cause, termination of treatment, or the most recent follow-up


Secondary Outcome Measures :
  1. overall response rate (ORR) [ Time Frame: at week 6, 12, 18, and 24 after randomization ]
    defined as the proportion of patients whose best overall response is either complete remission (CR) or partial remission (PR), which was evaluated in accordance with the International Working Group Recommendations for Response Criteria for non-Hodgkin's lymphoma

  2. complete remission (CR) rate [ Time Frame: at week 6, 12, 18, and 24 after randomization ]
    defined as the proportion of patients whose best overall response is complete remission, which was evaluated in accordance with the International Working Group Recommendations for Response Criteria for non-Hodgkin's lymphoma

  3. overall survival (OS) [ Time Frame: two year ]
    defined as time from the date of randomization to the date of death due to any cause or the most recent follow-up



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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pathologically confirmed diagnosis of CD20-positive diffuse large B-cell lymphoma
  • 60~80 years old
  • Ann Arbor stage I~IV
  • ECOG physical score of 0~2
  • Have not received previous treatment to lymphoma, including chemotherapy, radiotherapy, or biotherapy
  • Have at least one clinically measurable lesion: >= 2cm under physical examination, or >= 1.5cm under computed tomography (CT) or magnetic resonance (MR)
  • Life expectancy of >= 3 months
  • Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamate pyruvate transaminase and total bilirubin <= 2 × upper limit of normal (ULN)
  • Glomerular filtration rate (MDRD method) >= 30ml/min
  • No abnormalities in blood coagulative function
  • Generally normal bone marrow function: while blood cell >= 3,000/μL, absolute neutrophil count >= 1,500/μL, hemoglobin >= 100g/L, platelet >= 75,000/μL
  • No evidence of active hepatitis B or C virus, or human immunodeficiency virus infection
  • Left ventricular ejection fraction (LVEF) >= 45% measured by two dimensional echocardiography or multi-gated acquisition (MUGA) scan
  • Cardiac function of class I-II in New York Heart Association (NYHA) classification

Exclusion Criteria:

  • Patients with indolent lymphoma
  • Positive results for in situ hybridization for Epstein-Barr virus encoded RNA (EBER)
  • Serum Epstein-Barr virus DNA >= 1,000 copies/ml
  • Double-hit lymphoma confirmed by fluorescence in situ hybridization (FISH)
  • Primary mediastinal B-cell lymphoma
  • Involvement of central nervous system
  • Bulky disease (>= 10cm)
  • History of cardiac disease, including clinically significant ventricular tachycardia, atrial fibrillation, conduction block, myocardial infarction within 1 year, congestive heart failure, symptomatic coronary heart disease which needs medication
  • Known allergic reaction to any component of the agents used in the chemotherapeutic regimens that are used in the study
  • Previous exposure to anthracycline drugs, rituximab, or chemotherapy for lymphoma
  • History of malignant carcinoma within 5 years (except carcinoma in situ of the skin and uterine cervix, and prostatic carcinoma)
  • Currently enrolled in other clinical studies
  • Other conditions that the investigators consider as inappropriate for enrolling into this study

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): NCT02428751


Contacts
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Contact: Wen-qi Jiang, M.D. 86-20-87343765 wenqi_jiang@163.com
Contact: Xi-wen Bi, M.D. 86-13826050380 xiwen_bi@163.com

Locations
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China, Guangdong
Guangdong Provincial People's Hospital Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Wen-yu Li, M.D.    86-13924196915      
Principal Investigator: Wen-yu Li, M.D.         
Principal Investigator: Xin Du, M.D.         
Nanfang Hospital of Southern Medical Unversity Not yet recruiting
Guangzhou, Guangdong, China, 510060
Contact: Bing Xu, M.D.    86-18688900980      
Principal Investigator: Bing Xu, M.D.         
Sun Yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Zhi-ming Li, M.D.    86-13719189172    zhimingsysucc@163.com   
Contact: Xi-wen Bi, M.D.    86-13826050380    xiwen_bi@163.com   
Principal Investigator: Wen-qi Jiang, M.D.         
The First Affiliated Hospital of Guangzhou Medical University Not yet recruiting
Guangzhou, Guangdong, China, 510060
Contact: Huo Tan, M.D.    86-13602725539      
Principal Investigator: Huo Tan, M.D.         
The Second Affiliated Hospital of Sun Yat-sen University Not yet recruiting
Guangzhou, Guangdong, China, 510060
Contact: Li-ping Ma, M.D.    86-13600450776      
Principal Investigator: Li-ping Ma, M.D.         
The Third Affiliated Hospital of Sun Yat-sen University Not yet recruiting
Guangzhou, Guangdong, China, 510060
Contact: Xiang-yuan Wu, M.D.    86-13729813256      
Principal Investigator: Xiang-yuan Wu, M.D.         
Wujing Zongdui Hospital of Guangdong Province Not yet recruiting
Guangzhou, Guangdong, China, 510060
Contact: Tao Zhou, M.D.    86-18820019866      
Principal Investigator: Tao Zhou, M.D.         
Sponsors and Collaborators
Wenqi Jiang
Investigators
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Principal Investigator: Wen-qi Jiang, M.D. Sun Yat-sen University
Publications of Results:

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Responsible Party: Wenqi Jiang, Chief of Department of Internal Medicine, Sun Yat-sen University Cancer Center, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02428751    
Other Study ID Numbers: 308-2015-005
First Posted: April 29, 2015    Key Record Dates
Last Update Posted: November 18, 2015
Last Verified: November 2015
Keywords provided by Wenqi Jiang, Sun Yat-sen University:
Lymphoma, Large B-Cell, Diffuse
liposomal doxorubicin
doxorubicin
event-free survival
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Prednisone
Rituximab
Doxorubicin
Liposomal doxorubicin
Vincristine
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal