RecruitingPhase 1Phase 2NCT06760039

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

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


Sponsor

Sun Yat-sen University

Enrollment

112 participants

Start Date

Jan 10, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two chemotherapy regimens — R-CMOP (which uses a different drug called mitoxantrone instead of doxorubicin) versus standard R-CHOP — as initial treatment for adults with diffuse large B-cell lymphoma (DLBCL), a common and aggressive type of blood cancer. **You may be eligible if...** - You are between 18 and 80 years old - You have newly diagnosed DLBCL confirmed by biopsy - You have not yet received any treatment for DLBCL - You have at least one measurable tumor and are in reasonably good health (ECOG 0–2) - Your international prognostic score (IPI) is 2 or lower (indicating lower risk) **You may NOT be eligible if...** - You have a different subtype of large B-cell lymphoma or DLBCL that has transformed from another cancer - Your cancer has spread to the brain or spinal cord - You have HIV or AIDS - You are pregnant or breastfeeding - You have received prior cancer treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGR-CMOP Regimen

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

DRUGR-CHOP Regimen

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


Locations(10)

Fujian Provincial Cancer Hospital

Fuzhou, Fujian, China

Gansu Provincial Cancer Hospital

Lanzhou, Gansu, China

The Fifth Affiliated Hospital of Guangzhou Medical University.

Guangzhou, Guangdong, China

The Affiliated Hospital of Guangdong Medical University

Guangzhou, Guangdong, China

Shenzhen People's Hospital

Shenzhen, Guangdong, China

The Fifth Affiliated Hospital of Sun Yat-sen University

Zhuhai, Guangdong, China

Guangxi Zhuang Autonomous Region Cancer Hospital

Guilin, Guangxi, China

Ganzhou Cancer Hospital

Ganzhou, Jiangxi, China

Jiangxi Provincial Cancer Hospital

Nanchang, Jiangxi, China

Beijing Tongren Hospital

Beijing, China

View Full Details on ClinicalTrials.gov

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NCT06760039


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