RecruitingPhase 2NCT06136351

A Study of the Zanubrutinib Given in Combination With Bendamustine and Rituximab in (Elderly or TP53 Alterations or Chemotherapy Intolerance) Patients With Newly Diagnosed Mantle Cell Lymphoma


Sponsor

Ruijin Hospital

Enrollment

23 participants

Start Date

Nov 15, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to evaluate the efficacy and safety of Zanubrutinib given in combination with bendamustine and rituximab in (elderly or TP53 alterations or chemotherapy intolerance) patients with newly diagnosed mantle cell lymphoma.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests a combination of zanubrutinib (a BTK inhibitor pill) with bendamustine and rituximab (standard chemotherapy and immunotherapy) for patients newly diagnosed with mantle cell lymphoma (a type of B-cell blood cancer) who are elderly (65+), unable to tolerate intensive chemotherapy, or who have a specific high-risk genetic change called TP53 alteration. **You may be eligible if...** - You are 18 or older and newly diagnosed with mantle cell lymphoma (confirmed by biopsy) - You are 65 years or older, OR you are younger than 65 but chemotherapy-intolerant, OR you have a TP53 gene change in your cancer - Your heart and kidney function are adequate **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have active hepatitis B or C - You have an immune deficiency condition - You have had significant heart failure within the past 6 months - You have another active cancer - You have a serious infection 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

DRUGZanubrutinib

160 mg bid po, until disease progression, intolerance of drug toxicity or death, otherwise maintaining during the 2 years of follow-up

DRUGRituximab

375 mg/m\^2 ivgtt, D0 of each 28-day cycle

DRUGBendamustin

90mg/m\^2 ivgtt, D0 of each 28-day cycle


Locations(1)

Ruijin Hospital

Shanghai, Shanghai Municipality, China

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NCT06136351


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