Recruiting PHASE1, PHASE2 Diffuse Large B-Cell Lymphoma

Compares treatment options for Diffuse Large B-Cell Lymphoma

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

ClinicalTrials.gov ID: NCT06760039

What this study is testing

What is R-CMOP Regimen?

R-CMOP Regimen is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for diffuse large b-cell lymphoma.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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).
  • Phase 2: a mid-size study of how well it works
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 80

You may be able to join if

  • 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-

You likely can't join if

  • Other types of LBCL:Primary Cutaneous Diffuse Large B-cell Lymphoma (Leg Type), Primary Mediastinal (Thymic) Large B-cell Lymphoma, Lymphomatoid...
  • 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 people of childbearing age who do not want to use contraception.
See the full eligibility criteria
Who can join
  • 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
What rules you out
  • 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...
  • 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 people 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.

The study team makes the final eligibility decision.

Where it's taking place

  • Fuzhou, Fujian, China
  • Lanzhou, Gansu, China
  • Guangzhou, Guangdong, China
  • Shenzhen, Guangdong, China
  • Zhuhai, Guangdong, China
  • Guilin, Guangxi, China
  • Ganzhou, Jiangxi, China
  • Nanchang, Jiangxi, China
  • Beijing, China

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Fuzhou, Fujian, China; Lanzhou, Gansu, China; Guangzhou, Guangdong, China; Shenzhen, Guangdong, China; Zhuhai, Guangdong, China; Guilin, Guangxi, China and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.