Clinical trial NCT06760039: Safety and Efficacy of R-CMOP Versus R-CHOP in the Initial Treatment of DLBCL
Official title: Safety and Efficacy of R-CMOP Versus R-CHOP in the Initial Treatment of Low-risk and Medium-risk Diffuse Large B-cell Lymphoma (DLBCL): a Randomized, Controlled, Open-label, Multicenter, Phase Ib/II Clinical Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Diffuse Large B-Cell Lymphoma
Keywords: DLBCL
R-CHOP
Liposomal Mitoxantrone
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2025-01-06
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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.

Primary outcomes:
measure: 2-year event-free survival (EFS) rate assessed by the independent review committee
timeFrame: 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.
measure: RP2D(Phase Ib)
timeFrame: Cycle 1 in R-CMOP group (28 days)
measure: DLT(Phase Ib)
timeFrame: Cycle 1 in R-CMOP group (28 days)
Secondary outcomes:
measure: 2-year event-free survival (EFS) rate assessed by the investigators
timeFrame: 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.
measure: AE and SAE (Phase Ib)
timeFrame: Up to 24 weeks
measure: 2-year Progression-free survival(PFS)
timeFrame: Defined as the proportion of patients without disease progresion, treatment discontinuation, or death for any reason within 24 months of enrollment
measure: 2-year Overall survival(OS)
timeFrame: Defined as the proportion of patients without disease progresion, treatment discontinuation, or death for any reason within 24 months of enrollment
measure: Objective response rate (ORR)
timeFrame: Up to 24 weeks
measure: Complete response rate (CRR)
timeFrame: Up to 24 weeks
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Provincial Cancer Hospital
state: Fujian
city: Lanzhou
country: China
facility: Gansu Provincial Cancer Hospital
state: Gansu
city: Guangzhou
country: China
facility: The Fifth Affiliated Hospital of Guangzhou Medical University.
state: Guangdong
city: Guangzhou
country: China
facility: The Affiliated Hospital of Guangdong Medical University
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen People's Hospital
state: Guangdong
city: Zhuhai
country: China
facility: The Fifth Affiliated Hospital of Sun Yat-sen University
state: Guangdong
city: Guilin
country: China
facility: Guangxi Zhuang Autonomous Region Cancer Hospital
state: Guangxi
city: Ganzhou
country: China
facility: Ganzhou Cancer Hospital
state: Jiangxi
city: Nanchang
country: China
facility: Jiangxi Provincial Cancer Hospital
state: Jiangxi
city: Beijing
country: China
facility: Beijing Tongren Hospital
Study officials:
References: