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

NCT06760039 | Recruiting Phase 1

• 1 other identifier: B2024-737-01
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 10

Brief Summary

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).

Conditions

Diffuse Large B-Cell Lymphoma

Keywords

DLBCL; R-CHOP; Liposomal Mitoxantrone

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• 2-year event-free survival (EFS) rate assessed by the investigators

  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)

  Up to 24 weeks

• 2-year Progression-free survival(PFS)

  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)

  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)

  Up to 24 weeks

Study Arms (2)

Experimental group

EXPERIMENTAL

R-CMOP group

Drug: R-CMOP Regimen

Control group

ACTIVE COMPARATOR

R-CHOP group

Drug: R-CHOP Regimen

Interventions

R-CMOP Regimen DRUG

Rituximab intravenous drip, Cyclophosphamide intravenous drip, Liposomal Mitoxantrone intravenous drip, Vincristine intravenous drip, Prednisone orally

Experimental group

R-CHOP Regimen DRUG

Rituximab intravenous drip, Cyclophosphamide intravenous drip, Doxorubicinin intravenous drip, Vincristine intravenous drip, Prednisone orally

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.
• Transformed DLBCL.
• Patients with central nervous system involvement, or those who require high-dose methotrexate for prevention.
• The patients had previously received antitumor therapy.
• Patients with the infection of human immunodeficiency virus (HIV) and/or acquired immunodeficiency syndrome.
• Pregnant and lactating women and subjects of childbearing age who do not want to use contraception.
• Mentally ill persons or persons unable to obtain informed consent.
• The investigators think that the patient is not suitable for the study.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (10)

Fujian Provincial Cancer Hospital

Fuzhou, Fujian, China

NOT YET RECRUITING

Gansu Provincial Cancer Hospital

Lanzhou, Gansu, China

NOT YET RECRUITING

The Fifth Affiliated Hospital of Guangzhou Medical University.

Guangzhou, Guangdong, 510060, China

RECRUITING

The Affiliated Hospital of Guangdong Medical University

Guangzhou, Guangdong, China

NOT YET RECRUITING

Shenzhen People's Hospital

Shenzhen, Guangdong, China

NOT YET RECRUITING

The Fifth Affiliated Hospital of Sun Yat-sen University

Zhuhai, Guangdong, China

RECRUITING

Guangxi Zhuang Autonomous Region Cancer Hospital

Guilin, Guangxi, China

NOT YET RECRUITING

Ganzhou Cancer Hospital

Ganzhou, Jiangxi, China

NOT YET RECRUITING

Jiangxi Provincial Cancer Hospital

Nanchang, Jiangxi, China

NOT YET RECRUITING

Beijing Tongren Hospital

Beijing, China

NOT YET RECRUITING

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Qingqing Cai, MD. PhD.

CONTACT

0086-20-87342823; caiqq@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 30, 2024
• First Posted: January 6, 2025
• Study Start: January 10, 2025
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): November 30, 2028
• Last Updated: April 3, 2025

Record last verified: 2025-04

Locations

CN (10)