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Recruiting NCT06760039

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

Phase I / Phase II Interventional Diffuse Large B-Cell Lymphoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: R-CMOP Regimen, R-CHOP Regimen.
Who it may be relevant to
Registry conditions: Diffuse Large B-Cell Lymphoma. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

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).

Interventions

  • Drug R-CMOP Regimen
    Rituximab intravenous drip, Cyclophosphamide intravenous drip, Liposomal Mitoxantrone intravenous drip, Vincristine intravenous drip, Prednisone orally
  • Drug R-CHOP Regimen
    Rituximab intravenous drip, Cyclophosphamide intravenous drip, Doxorubicinin intravenous drip, Vincristine intravenous drip, Prednisone orally

Primary outcome measures

  • 2-year event-free survival (EFS) rate assessed by the independent review committee [Time frame: 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.]
  • RP2D(Phase Ib) [Time frame: Cycle 1 in R-CMOP group (28 days)]
  • DLT(Phase Ib) [Time frame: Cycle 1 in R-CMOP group (28 days)]
Secondary outcome measures (6)
  • 2-year event-free survival (EFS) rate assessed by the investigators [Time frame: 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.]
  • AE and SAE (Phase Ib) [Time frame: Up to 24 weeks]
  • 2-year Progression-free survival(PFS) [Time frame: Defined as the proportion of patients without disease progresion, treatment discontinuation, or death for any reason within 24 months of enrollment]
  • 2-year Overall survival(OS) [Time frame: Defined as the proportion of patients without disease progresion, treatment discontinuation, or death for any reason within 24 months of enrollment]
  • Objective response rate (ORR) [Time frame: Up to 24 weeks]
  • Complete response rate (CRR) [Time frame: Up to 24 weeks]

Eligibility criteria

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.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 10 centers
  • Fujian Provincial Cancer Hospital — Fuzhou
  • Gansu Provincial Cancer Hospital — Lanzhou
  • The Fifth Affiliated Hospital of Guangzhou Medical University. — Guangzhou
  • The Affiliated Hospital of Guangdong Medical University — Guangzhou
  • Shenzhen People's Hospital — Shenzhen
  • The Fifth Affiliated Hospital of Sun Yat-sen University — Zhuhai
  • Guangxi Zhuang Autonomous Region Cancer Hospital — Guilin
  • Ganzhou Cancer Hospital — Ganzhou
  • … and 2 more centers

Identifiers

NCT: NCT06760039 · B2024-737-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗