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

Lymphoma, Mantle-Cell

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

Inclusion Criteria8

years
Histopathologically confirmed mantle cell lymphoma according to the 5th edition of the World Health Organization (WHO)
FISH with del(17p)/TP53 mutation or ≥65 years; or\<65 years but chemotherapy intolerance;
Life expectancy of \> 3 months (in the opinion of the investigator);
Creatinine Clearance Rate (CCR) ≥ 50 mL/min or estimated Glomerular Filtration ●Rate (eGFR) ≥ 60 mL/(min·1.73 m\^2);
International Normalized Ratio (INR) ≤ 1.5 and activated Partial Thromboplastin Time (aPTT) ≤ 1.5 times the upper limit of normal;
Left Ventricular Ejection Fraction (LVEF) ≥ 50%;
Agreeing to provide written informed consent prior to any special examination or procedure for the research on their own or legal representative.

Exclusion Criteria9

Pregnant or lactating women;
Known Hepatitis B Virus (HBV) and/or Hepatitis C Virus (HCV) infection (HBV infection refers to HBV-DNA \> detectable limit);
With acquired or congenital immunodeficiency;
With congestive heart failure in 6 months before enrollment, New York Heart Association (NYHA) heart function class III or IV, or LVEF \< 50%;
Known to be allergic to the test drug ingredients;
Diagnosed with or being treated for malignancy other than lymphoma;
With severe infection;
Substance abuse, medical, psychological, or social conditions that may interfere with the subjects' participation in the study or evaluation of the study results;
Deemed unsuitable for the group.

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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