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

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: Recruiting
• Conditions: Diffuse Large B-Cell Lymphoma
• Intervention / Treatment: Drug: R-CMOP Regimen; Drug: R-CHOP Regimen

• Study Type: Interventional
• Enrollment (Estimated): 112
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Qingqing Cai, MD. PhD.; Phone Number: 0086-20-87342823; Email: caiqq@sysucc.org.cn

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: Xinggui Chen; Phone Number: 13652859129; Email: baisr@sysucc.org.cn
    • 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

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
2-year event-free survival (EFS) rate assessed by the independent review committee	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)	Phase II Recommended Dose	Cycle 1 in R-CMOP group (28 days)
DLT(Phase Ib)	Dose-limiting toxicity	Cycle 1 in R-CMOP group (28 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
2-year event-free survival (EFS) rate assessed by the investigators	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)	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)	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)	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)	To investigate the antitumor efficacy	Up to 24 weeks
Complete response rate (CRR)	To investigate the antitumor efficacy	Up to 24 weeks

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2025
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): November 30, 2028

Study Registration Dates

• First Submitted: December 30, 2024
• First Submitted That Met QC Criteria: December 30, 2024
• First Posted (Actual): January 6, 2025

Study Record Updates

• Last Update Posted (Actual): April 3, 2025
• Last Update Submitted That Met QC Criteria: April 2, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: DLBCL; R-CHOP; Liposomal Mitoxantrone
• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse
• Other Study ID 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