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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 18 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.

Locations
Other Locations
China
Ruijin Hospital
RECRUITING
Shanghai
Time Frame
Start Date: 2023-11-15
Estimated Completion Date: 2027-11-01
Participants
Target number of participants: 23
Treatments
Experimental: ZBR
Sponsors
Leads: Ruijin Hospital

This content was sourced from clinicaltrials.gov