Overview
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).
Eligibility
Key Inclusion Criteria:
- 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.
Key Exclusion Criteria:
- 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.