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
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
2-year event-free survival (EFS) rate assessed by the independent review committee — 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
RP2D(Phase Ib) — Cycle 1 in R-CMOP group (28 days) Phase II Recommended Dose
DLT(Phase Ib) — Cycle 1 in R-CMOP group (28 days) Dose-limiting toxicity
Trial sites (10)
Facility
City
Region
Status
Fujian Provincial Cancer Hospital
Fuzhou
Fujian
Not Yet Recruiting
Gansu Provincial Cancer Hospital
Lanzhou
Gansu
Not Yet Recruiting
The Fifth Affiliated Hospital of Guangzhou Medical University.
Guangzhou
Guangdong
Recruiting
The Affiliated Hospital of Guangdong Medical University
Guangzhou
Guangdong
Not Yet Recruiting
Shenzhen People's Hospital
Shenzhen
Guangdong
Not Yet Recruiting
The Fifth Affiliated Hospital of Sun Yat-sen University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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