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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Ruijin Hospital
  Shanghai, Shanghai Municipality, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.