Tests zanubrutinib with bendamustine and rituximab for new mantle cell lymphoma
Tests zanubrutinib with two other drugs in adults with new mantle cell lymphoma.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- Shanghai, ChinaSee the site
- Phase
- Phase 2
Where in China
- Ruijin hospitalShanghai, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Ruijin Hospital
- Trial code
- NCT06136351
- Record updated
- 29 November 2023
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: Known Hepatitis B Virus (HBV) and/or Hepatitis C Virus (HCV) infection (HBV infection refers to HBV-DNA > detectable limit); 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; With congestive heart failure in 6 months before enrollment, New York Heart Association (NYHA) heart function class III or IV, or LVEF < 50%; Pregnant or lactating women; With acquired or congenital immunodeficiency; Deemed unsuitable for the group.