Safety and Efficacy of R-CMOP Versus R-CHOP in the Initial Treatment of DLBCL

April 2, 2025 updated by: Qingqing Cai, Sun Yat-sen University

Safety and Efficacy of R-CMOP Versus R-CHOP in the Initial Treatment of Low-risk and Medium-risk Diffuse Large B-cell Lymphoma (DLBCL): a Randomized, Controlled, Open-label, Multicenter, Phase Ib/II Clinical Study

This is a prospective, randomized, controlled, multicenter, phase II clinical trial to evaluate the efficacy and safety of R-CMOP versus R-CHOP in the initial treatment of low-risk and medium-risk diffuse large B-cell lymphoma (DLBCL).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
112

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
      • Beijing, China
        • Not yet recruiting
        • Beijing Tongren Hospital
        • Contact:
          • Liang Wang
          • Phone Number: 15001108693
    • Fujian
      • Fuzhou, Fujian, China
        • Not yet recruiting
        • Fujian Provincial Cancer Hospital
        • Contact:
          • Hongming He
          • Phone Number: 13799361913
    • Gansu
      • Lanzhou, Gansu, China
        • Not yet recruiting
        • Gansu Provincial Cancer Hospital
        • Contact:
          • Junfeng Jiang
          • Phone Number: 13893332604
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • The Fifth Affiliated Hospital of Guangzhou Medical University.
        • Contact:
          • Runhui Zheng
          • Phone Number: 13560225061
      • Guangzhou, Guangdong, China
        • Not yet recruiting
        • The Affiliated Hospital of Guangdong Medical University
        • Contact:
      • Shenzhen, Guangdong, China
        • Not yet recruiting
        • Shenzhen People's Hospital
        • Contact:
          • Jihao Zhou
          • Phone Number: 18718678693
      • Zhuhai, Guangdong, China
        • Recruiting
        • The fifth affiliated hospital of sun yat-sen university
        • Contact:
          • Nan Chen
          • Phone Number: 13631270598
    • Guangxi
      • Guilin, Guangxi, China
        • Not yet recruiting
        • Guangxi Zhuang Autonomous Region Cancer Hospital
        • Contact:
          • Hong Cen
          • Phone Number: 13507711671
    • Jiangxi
      • Ganzhou, Jiangxi, China
        • Not yet recruiting
        • Ganzhou Cancer Hospital
        • Contact:
          • Qingfang Zeng
          • Phone Number: 13870711700
      • Nanchang, Jiangxi, China
        • Not yet recruiting
        • Jiangxi Provincial Cancer Hospital
        • Contact:
          • Wuping Li
          • Phone Number: 13870659916

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  1. Aged ≥18,≤80 years, both male and female.
  2. Pathologically confirmed DLBCL
  3. No prior treatment for DLBCL.
  4. There must be at least one measurable or evaluable lesion that meets the evaluation criteria for Lugano 2014 lymphoma.
  5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-
  6. Expected survival ≥3 months.
  7. International Prognostic Index (IPI) ≤ 2
  8. Sufficient bone marrow, liver, and kidney function.

Key Exclusion Criteria:

  1. Other types of LBCL:Primary Cutaneous Diffuse Large B-cell Lymphoma (Leg Type), Primary Mediastinal (Thymic) Large B-cell Lymphoma, Lymphomatoid Granulomatosis, ALK-positive Diffuse Large B-cell Lymphoma, Plasmablastic Lymphoma, Intravascular Large B-cell Lymphoma, T-cell/Histiocyte-rich Large B-cell Lymphoma, and others.
  2. Transformed DLBCL.
  3. Patients with central nervous system involvement, or those who require high-dose methotrexate for prevention.
  4. The patients had previously received antitumor therapy.
  5. Patients with the infection of human immunodeficiency virus (HIV) and/or acquired immunodeficiency syndrome.
  6. Pregnant and lactating women and subjects of childbearing age who do not want to use contraception.
  7. Mentally ill persons or persons unable to obtain informed consent.
  8. The investigators think that the patient is not suitable for the 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental group
R-CMOP group
Drug: R-CMOP Regimen
Rituximab intravenous drip, Cyclophosphamide intravenous drip, Liposomal Mitoxantrone intravenous drip, Vincristine intravenous drip, Prednisone orally
Active Comparator: Control group
R-CHOP group
Drug: R-CHOP Regimen
Rituximab intravenous drip, Cyclophosphamide intravenous drip, Doxorubicinin intravenous drip, Vincristine intravenous drip, Prednisone orally

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
2-year event-free survival (EFS) rate assessed by the independent review committee
Time Frame: Defined as the proportion of patients without disease progresion, treatment discontinuation, or death for any reason within 24 months of enrollment, based on the independent review committee's assessment.
To investigate the antitumor efficacy
Defined as the proportion of patients without disease progresion, treatment discontinuation, or death for any reason within 24 months of enrollment, based on the independent review committee's assessment.
RP2D(Phase Ib)
Time Frame: Cycle 1 in R-CMOP group (28 days)
Phase II Recommended Dose
Cycle 1 in R-CMOP group (28 days)
DLT(Phase Ib)
Time Frame: Cycle 1 in R-CMOP group (28 days)
Dose-limiting toxicity
Cycle 1 in R-CMOP group (28 days)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
2-year event-free survival (EFS) rate assessed by the investigators
Time Frame: Defined as the proportion of patients without disease progresion, treatment discontinuation, or death for any reason within 24 months of enrollment, based on the investigators' assessment.
To investigate the anti-tumor efficacy
Defined as the proportion of patients without disease progresion, treatment discontinuation, or death for any reason within 24 months of enrollment, based on the investigators' assessment.
AE and SAE (Phase Ib)
Time Frame: Up to 24 weeks
Number of participants with adverse events (AE) and severe adverse events (SAE) in phase Ib
Up to 24 weeks
2-year Progression-free survival(PFS)
Time Frame: Defined as the proportion of patients without disease progresion, treatment discontinuation, or death for any reason within 24 months of enrollment
To investigate the antitumor efficacy
Defined as the proportion of patients without disease progresion, treatment discontinuation, or death for any reason within 24 months of enrollment
2-year Overall survival(OS)
Time Frame: Defined as the proportion of patients without disease progresion, treatment discontinuation, or death for any reason within 24 months of enrollment
To investigate the antitumor efficacy
Defined as the proportion of patients without disease progresion, treatment discontinuation, or death for any reason within 24 months of enrollment
Objective response rate (ORR)
Time Frame: Up to 24 weeks
To investigate the antitumor efficacy
Up to 24 weeks
Complete response rate (CRR)
Time Frame: Up to 24 weeks
To investigate the antitumor efficacy
Up to 24 weeks

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sun Yat-sen University

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 10, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 30, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 30, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 6, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 3, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B2024-737-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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