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

Last updated: November 24, 2023
Sponsor: Ruijin Hospital
Overall Status: Active - Recruiting

Phase

2

Condition

Lymphoma

Treatment

Bendamustin

Rituximab

Zanubrutinib

Clinical Study ID

NCT06136351
ZBR-01
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • 18 years
  • Histopathologically confirmed mantle cell lymphoma according to the 5th editionof the World Health Organization (WHO)
  • FISH with del(17p)/TP53 mutation or ≥65 years; or<65 years but chemotherapyintolerance;
  • 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 ThromboplastinTime (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 orprocedure for the research on their own or legal representative.

Exclusion

Exclusion Criteria:

  • Pregnant or lactating women;
  • Known Hepatitis B Virus (HBV) and/or Hepatitis C Virus (HCV) infection (HBV infectionrefers to HBV-DNA > detectable limit);
  • With acquired or congenital immunodeficiency;
  • With congestive heart failure in 6 months before enrollment, New York HeartAssociation (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 withthe subjects' participation in the study or evaluation of the study results;
  • Deemed unsuitable for the group.

Study Design

Total Participants: 23
Treatment Group(s): 3
Primary Treatment: Bendamustin
Phase: 2
Study Start date:
November 15, 2023
Estimated Completion Date:
November 01, 2027

Connect with a study center

  • Ruijin Hospital

    Shanghai, Shanghai 200020
    China

    Active - Recruiting

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