Status:
RECRUITING
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
Lead Sponsor:
Ruijin Hospital
Conditions:
Lymphoma, Mantle-Cell
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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) patie...
Eligibility Criteria
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
- 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.
Key Trial Info
Start Date :
November 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2027
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT06136351
Start Date
November 15 2023
End Date
November 1 2027
Last Update
November 29 2023
Active Locations (1)
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1
Ruijin Hospital
Shanghai, Shanghai Municipality, China, 200020