Safety and Efficacy of R-CMOP Versus R-CHOP in the Initial Treatment of DLBCL
- Conditions
- Diffuse Large B-Cell Lymphoma
- Interventions
- Drug: R-CMOP RegimenDrug: R-CHOP Regimen
- Registration Number
- NCT06760039
- Lead Sponsor
- Sun Yat-sen University
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 112
- Aged β₯18,β€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 β₯3 months.
- International Prognostic Index (IPI) β€ 2
- Sufficient bone marrow, liver, and kidney function.
Key
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental group R-CMOP Regimen R-CMOP group Control group R-CHOP Regimen R-CHOP group
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method AE and SAE (Phase Ib) Up to 24 weeks Number of participants with adverse events (AE) and severe adverse events (SAE) in phase Ib
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. To investigate the anti-tumor efficacy
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 To investigate the antitumor efficacy
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 To investigate the antitumor efficacy
Objective response rate (ORR) Up to 24 weeks To investigate the antitumor efficacy
Complete response rate (CRR) Up to 24 weeks To investigate the antitumor efficacy
Trial Locations
- Locations (10)
Fujian Provincial Cancer Hospital
π¨π³Fuzhou, Fujian, China
Gansu Provincial Cancer Hospital
π¨π³Lanzhou, Gansu, China
The Fifth Affiliated Hospital of Guangzhou Medical University.
π¨π³Guangzhou, Guangdong, China
The Affiliated Hospital of Guangdong Medical University
π¨π³Guangzhou, Guangdong, China
Shenzhen People's Hospital
π¨π³Shenzhen, Guangdong, China
The Fifth Affiliated Hospital of Sun Yat-sen University
π¨π³Zhuhai, Guangdong, China
Guangxi Zhuang Autonomous Region Cancer Hospital
π¨π³Guilin, Guangxi, China
Ganzhou Cancer Hospital
π¨π³Ganzhou, Jiangxi, China
Jiangxi Provincial Cancer Hospital
π¨π³Nanchang, Jiangxi, China
Beijing Tongren Hospital
π¨π³Beijing, China