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

Phase 1
Not yet recruiting
Conditions
Diffuse Large B-Cell Lymphoma
Interventions
Drug: R-CMOP Regimen
Drug: 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
Inclusion Criteria
  1. Aged β‰₯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 β‰₯3 months.
  7. International Prognostic Index (IPI) ≀ 2
  8. Sufficient bone marrow, liver, and kidney function.

Key

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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.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Experimental groupR-CMOP RegimenR-CMOP group
Control groupR-CHOP RegimenR-CHOP group
Primary Outcome Measures
NameTimeMethod
2-year event-free survival (EFS) rate assessed by the independent review committeeDefined 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
NameTimeMethod
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 investigatorsDefined 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

πŸ‡¨πŸ‡³

Fuzhou, Fujian, China

Gansu Provincial Cancer Hospital

πŸ‡¨πŸ‡³

Lanzhou, Gansu, China

The Fifth Affiliated Hospital of Guangzhou Medical University.

πŸ‡¨πŸ‡³

Guangzhou, Guangdong, China

The Affiliated Hospital of Guangdong Medical University

πŸ‡¨πŸ‡³

Guangzhou, Guangdong, China

Shenzhen People's Hospital

πŸ‡¨πŸ‡³

Shenzhen, Guangdong, China

The Fifth Affiliated Hospital of Sun Yat-sen University

πŸ‡¨πŸ‡³

Zhuhai, Guangdong, China

Guangxi Zhuang Autonomous Region Cancer Hospital

πŸ‡¨πŸ‡³

Guilin, Guangxi, China

Ganzhou Cancer Hospital

πŸ‡¨πŸ‡³

Ganzhou, Jiangxi, China

Jiangxi Provincial Cancer Hospital

πŸ‡¨πŸ‡³

Nanchang, Jiangxi, China

Beijing Tongren Hospital

πŸ‡¨πŸ‡³

Beijing, China

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