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

Ruijin Hospital1 site in 1 country23 target enrollmentNovember 15, 2023

ConditionsLymphoma, Mantle-Cell

InterventionsZanubrutinib Rituximab Bendamustin

DrugsZanubrutinib Rituximab Bendamustin

Overview

Phase: Phase 2
Intervention: Zanubrutinib
Conditions: Lymphoma, Mantle-Cell
Sponsor: Ruijin Hospital
Enrollment: 23
Locations: 1
Primary Endpoint: 2-year Progression-Free Survival
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

November 15, 2023

End Date

November 1, 2027

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Ruijin Hospital

Responsible Party

Principal Investigator

Zhao Weili

Professor

Ruijin Hospital

Eligibility Criteria

Inclusion Criteria

•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 Criteria

•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.

Arms & Interventions

ZBR

Intervention: Zanubrutinib

ZBR

Intervention: Rituximab

ZBR

Intervention: Bendamustin

Outcomes

Primary Outcomes

2-year Progression-Free Survival

Time Frame: 2 years

Progression-free survival was defined as the time from the date of first treatment until the date of the first documented day of disease progression or relapse, according to 2014 Lugano criteria, or death from any cause, whichever occurred first.

Secondary Outcomes

CRR(End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=28 days])
OS(Baseline up to data cut-off (up to approximately 2 years))
Adverse Events(Baseline up to data cut-off (up to approximately 2 years))
ORR(End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=28 days])