RecruitingPhase 3NCT05051891

A Randomized, Open-label, Multi-center, Phase III Study of Orelabrutinib in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) vs. R-CHOP Alone in Patients With Treatment-naїve Mantle Cell Lymphoma

Sponsor

Beijing InnoCare Pharma Tech Co., Ltd.

Enrollment

356 participants

Start Date

Dec 22, 2021

Study Type

INTERVENTIONAL

Conditions

Treatment-naїve Mantle Cell Lymphoma

Summary

To evaluate the efficacy of orelabrutinib combined with R-CHOP vs. R-CHOP alone in the treatment of treatment-naїve mantle cell lymphoma.

Eligibility

Min Age: 60 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding a targeted oral drug called orelabrutinib to the standard chemotherapy regimen (R-CHOP) can improve outcomes for older patients with mantle cell lymphoma (a type of blood cancer) who are newly diagnosed and not eligible for a stem cell transplant. **You may be eligible if...** - You are between 60 and 80 years old with newly diagnosed mantle cell lymphoma - If you are 60–65, you must not be eligible for a stem cell transplant - You have never had systemic treatment for mantle cell lymphoma - Your overall health is reasonably good (ECOG 0–2) - Your expected survival is more than 6 months **You may NOT be eligible if...** - You have uncontrolled heart disease - You had a stroke or brain bleed within the past 6 months - You have mental or cognitive conditions that limit your ability to consent or follow the protocol - You have significant active infections like HIV or hepatitis 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

DRUGOrelabrutinib and R-CHOP

Orelabrutinib in Combinaion with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP)

DRUGR-CHOP

Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP)

Locations(22)

Tumor in Hunan Province

Hunan, Changsha, China

The First Hospital of China Medical University

Shenyang, Liaojing, China

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Hospital of Hematology, Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, China

West China Hospital,Sichuan University

Chengdu, Sichuan, China

The First Affiliated Hospital of Guangxi Medical University

Guangxi, Nanning, China

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Anhui Province Cancer Hospital

Hefei, Anhui, China

Wuhan Union Hospital

Wuhan, Hubei, China

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Shandong Provincial Hospital

Jinan, Shandong, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Guangzhou First People's Hospital

Guangzhou, Guangdong, China

The First Hospital of Jilin University

Changchun, Jilin, China

Henan Tumor Hospital

Zhengzhou, Henan, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

he First Affiliated Hospital of Zhengjiang University

Hangzhou, Zhejiang, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, China

View Full Details on ClinicalTrials.gov

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NCT05051891