Combining Zanubrutinib with Bendamustine and Rituximab for Elderly Patients with Newly Diagnosed Mantle Cell Lymphoma

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

This study is testing if combining a new drug called Zanubrutinib with two other treatments can help older patients with newly diagnosed mantle cell lymphoma feel better and improve their health.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Ruijin Hospital (Academic / other)
• Drugs / interventions: chemotherapy, rituximab, Zanubrutinib
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06136351 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and efficacy of Zanubrutinib when used alongside bendamustine and rituximab in patients with newly diagnosed mantle cell lymphoma who are either elderly, have TP53 alterations, or are intolerant to chemotherapy. The trial focuses on patients aged 18 and older, specifically targeting those with certain genetic markers or age-related factors that complicate treatment. Participants will be monitored for their response to the treatment regimen over the course of the study.

Who should consider this trial

Good fit: Ideal candidates include patients aged 18 and older with newly diagnosed mantle cell lymphoma, particularly those who are elderly, have TP53 mutations, or are intolerant to chemotherapy.

Not a fit: Patients who are pregnant or lactating, or those with active Hepatitis B or C infections may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment combination could provide a new effective option for patients with challenging mantle cell lymphoma cases.

How similar studies have performed: While this specific combination has not been widely tested, similar approaches using targeted therapies in lymphoma have shown promise in other studies.

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.

Where this trial is running

Shanghai, Shanghai Municipality

• Ruijin Hospital — Shanghai, Shanghai Municipality, China (Recruiting)

Conditions Lymphoma, Mantle-Cell