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

Launched by RUIJIN HOSPITAL · Nov 14, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with newly diagnosed mantle cell lymphoma, a type of blood cancer. The treatment combines three medications: Zanubrutinib, bendamustine, and rituximab. The trial is particularly focused on helping older patients or those who have specific genetic changes (like TP53 alterations) or who cannot tolerate standard chemotherapy.

To be eligible for the trial, participants need to be at least 18 years old and have been diagnosed with mantle cell lymphoma that meets certain criteria. They should either be 65 years or older, have specific genetic changes related to the disease, or be younger than 65 but unable to undergo traditional chemotherapy. Participants will receive the study treatment and will be monitored closely for safety and how well the treatment works. It's important for potential participants to discuss any concerns with their doctor and to understand the commitment involved in joining the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• 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.