RecruitingPhase 2NCT06647940

Orelabrutinib in Combination with R-CHOP for CD5-positive DLBCL Patients(Rocket Trial)

Orelabrutinib in Combination with R-CHOP for CD5-positive DLBCL Patients: a Single-arm, Multicenter, Phase II Clinical Trial(Rocket Trial)


Sponsor

Sun Yat-sen University

Enrollment

39 participants

Start Date

Nov 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a prospective, single-arm, multicenter, phase II clinical trial to evaluate the efficacy and safety of orelabrutinib combined with the R-CHOP (rituximab, cyclophosphamide, vincristine, doxorubicin, and prednisone) regimen as first-line treatment in CD5-positive diffuse large B-cell lymphoma (DLBCL) patients.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding orelabrutinib (a targeted therapy that blocks a cancer-driving protein called BTK) to the standard R-CHOP chemotherapy regimen works better for a specific subtype of aggressive lymphoma called CD5-positive diffuse large B-cell lymphoma (DLBCL). **You may be eligible if...** - You are 18 or older - You have been diagnosed with CD5-positive DLBCL confirmed by biopsy - You have at least one measurable tumor - You are in good physical condition (ECOG 0–2) - Your bone marrow, liver, and kidney function are sufficient - Your expected survival is at least 3 months **You may NOT be eligible if...** - You have DLBCL that has transformed from another lymphoma type - The cancer has spread to your central nervous system (brain/spinal cord) - You have previously received a BTK inhibitor - You have active serious infections 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 Oral Tablet

Orelabrutinib (150 mg po D1-D21) is added from the second cycle of R-CHOP regimen

DRUGR-CHOP Protocol

Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone


Locations(11)

Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University,

Guangzhou, China, China

Gansu Cancer Hospital

Lanzhou, Gansu, China

Dongguan People's Hospital

Dongguan, Guangdong, China

Fifth Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

First People's Hospital of Guangzhou

Guangzhou, Guangdong, China

Guangdong Provincial Hospital of Traditional Chinese Medicine

Guangzhou, Guangdong, China

Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

First Affiliated Hospital of Shantou University Medical College.

Shantou, Guangdong, China

Shenzhen People's Hospital

Shenzhen, Guangdong, China

Zhaoqing First People's Hospital

Zhaoqing, Guangdong, China

Fifth Affiliated Hospital of Sun Yat-sen University

Zhuhai, Guangdong, China

View Full Details on ClinicalTrials.gov

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NCT06647940


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