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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRuijin Hospital

About this trial

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

Qualifiers

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);

Disqualifiers

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%;

Trial design

Treatments tested in this trial

  • Zanubrutinib
  • Rituximab
  • Bendamustin

Treatment groups

23 Participants
are divided into 1 treatment group

Sponsors and collaborators