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

Sun Yat-sen University

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Diffuse Large B-Cell Lymphoma

Treatments: Drug: R-CHOP Regimen; Drug: R-CMOP Regimen

Study type: Interventional

Funder types: Other

Identifiers

NCT06760039

B2024-737-01

Details and patient eligibility

About

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).

Enrollment: 112 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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112 participants in 2 patient groups

Experimental group

Experimental group

Description:

R-CMOP group

Treatment:

Drug: R-CMOP Regimen

Control group

Active Comparator group

Description:

R-CHOP group

Treatment:

Drug: R-CHOP Regimen