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

November 17, 2015 updated by: Wenqi Jiang

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

216

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
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Sun Yat-sen University Cancer Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Wen-qi Jiang, M.D.
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Guangdong Provincial People's Hospital
        • Contact:
          • Wen-yu Li, M.D.
          • Phone Number: 86-13924196915
        • Principal Investigator:
          • Wen-yu Li, M.D.
        • Principal Investigator:
          • Xin Du, M.D.
      • Guangzhou, Guangdong, China, 510060
        • Not yet recruiting
        • Nanfang Hospital of Southern Medical Unversity
        • Contact:
          • Bing Xu, M.D.
          • Phone Number: 86-18688900980
        • Principal Investigator:
          • Bing Xu, M.D.
      • Guangzhou, Guangdong, China, 510060
        • Not yet recruiting
        • The First Affiliated Hospital of Guangzhou Medical University
        • Contact:
          • Huo Tan, M.D.
          • Phone Number: 86-13602725539
        • Principal Investigator:
          • Huo Tan, M.D.
      • Guangzhou, Guangdong, China, 510060
        • Not yet recruiting
        • The Second Affiliated Hospital of Sun Yat-sen University
        • Contact:
          • Li-ping Ma, M.D.
          • Phone Number: 86-13600450776
        • Principal Investigator:
          • Li-ping Ma, M.D.
      • Guangzhou, Guangdong, China, 510060
        • Not yet recruiting
        • The third affiliated hospital of Sun Yat-Sen University
        • Contact:
          • Xiang-yuan Wu, M.D.
          • Phone Number: 86-13729813256
        • Principal Investigator:
          • Xiang-yuan Wu, M.D.
      • Guangzhou, Guangdong, China, 510060
        • Not yet recruiting
        • Wujing Zongdui Hospital of Guangdong Province
        • Principal Investigator:
          • Tao Zhou, M.D.
        • Contact:
          • Tao Zhou, M.D.
          • Phone Number: 86-18820019866

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

56 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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
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: 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
Drug: Pegylated liposomal doxorubicin
30 mg/m2, IV (in the vein) on day 1 of each 21 day cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
two year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at week 6, 12, 18, and 24 after randomization
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
at week 6, 12, 18, and 24 after randomization
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
two year

Collaborators and Investigators

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

Sponsor

Wenqi Jiang

Investigators

  • Principal Investigator: Wen-qi Jiang, M.D., Sun Yat-sen University

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

September 1, 2015

Primary Completion (Anticipated)

March 1, 2020

Study Completion (Anticipated)

May 1, 2020

Study Registration Dates

First Submitted

April 17, 2015

First Submitted That Met QC Criteria

April 23, 2015

First Posted (Estimate)

April 29, 2015

Study Record Updates

Last Update Posted (Estimate)

November 18, 2015

Last Update Submitted That Met QC Criteria

November 17, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 308-2015-005

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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