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NCT Number: NCT06760039

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

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).

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Key information

Conditions

Diffuse Large B-cell Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Fujian Provincial Cancer Hospital, Fuzhou, Fujian, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key 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.

Key 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.

Treatment and study plan

R-CMOP Regimen

Drug

Rituximab intravenous drip, Cyclophosphamide intravenous drip, Liposomal Mitoxantrone intravenous drip, Vincristine intravenous drip, Prednisone orally

R-CHOP Regimen

Drug

Rituximab intravenous drip, Cyclophosphamide intravenous drip, Doxorubicinin intravenous drip, Vincristine intravenous drip, Prednisone orally

Primary outcomes

  1. 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.

    To investigate the antitumor efficacy

  2. RP2D(Phase Ib)

    Time frame: Cycle 1 in R-CMOP group (28 days)

    Phase II Recommended Dose

  3. DLT(Phase Ib)

    Time frame: Cycle 1 in R-CMOP group (28 days)

    Dose-limiting toxicity

Secondary outcomes

  1. 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.

    To investigate the anti-tumor efficacy

  2. AE and SAE (Phase Ib)

    Time frame: Up to 24 weeks

    Number of participants with adverse events (AE) and severe adverse events (SAE) in phase Ib

  3. 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

    To investigate the antitumor efficacy

  4. 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

    To investigate the antitumor efficacy

  5. Objective response rate (ORR)

    Time frame: Up to 24 weeks

    To investigate the antitumor efficacy

  6. Complete response rate (CRR)

    Time frame: Up to 24 weeks

    To investigate the antitumor efficacy

Study contacts

Contact information is provided by the study sponsor or research team.

Qingqing Cai, MD. PhD.

CONTACT

[email protected]

0086-20-87342823

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jan 6, 2025
Registry last updated
Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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