Recruiting NCT06136351
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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Zanubrutinib, Rituximab, Bendamustin.
- Who it may be relevant to
- Registry conditions: Lymphoma, Mantle-Cell. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug Zanubrutinib
160 mg bid po, until disease progression, intolerance of drug toxicity or death, otherwise maintaining during the 2 years of follow-up - Drug Rituximab
375 mg/m\^2 ivgtt, D0 of each 28-day cycle - Drug Bendamustin
90mg/m\^2 ivgtt, D0 of each 28-day cycle
Primary outcome measures
- 2-year Progression-Free Survival [Time frame: 2 years]
Secondary outcome measures (4)
- ORR [Time frame: End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=28 days]]
- CRR [Time frame: End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=28 days]]
- OS [Time frame: Baseline up to data cut-off (up to approximately 2 years)]
- Adverse Events [Time frame: Baseline up to data cut-off (up to approximately 2 years)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Ruijin Hospital — Shanghai
Identifiers
NCT: NCT06136351 · ZBR-01