Clinical Trials in China / NCT06136351
Recruiting
Phase 2
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
NCT06136351 · tracked via the Priya Life Science China tracker
Condition(s) studied
Lymphoma, Mantle-Cell
Investigational drug(s) / intervention(s)
Zanubrutinib: 160 mg bid po, until disease progression, intolerance of drug toxicity or death, otherwise maintaining during the 2 years of follow-up
Rituximab: 375 mg/m\^2 ivgtt, D0 of each 28-day cycle
Bendamustin: 90mg/m\^2 ivgtt, D0 of each 28-day cycle
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
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.
Primary outcome measure(s)
- 2-year Progression-Free Survival — 2 years
Progression-free survival was defined as the time from the date of first treatment until the date of the first documented day of disease progression or relapse, according to 2014 Lugano criteria, or death from any cause, whichever occurred first.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Ruijin Hospital | Shanghai | Shanghai Municipality | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06136351 on ClinicalTrials.gov ↗ ← All trials in China