Clinical trial · Interventional
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
NCT06136351CI-TRIAL-00071790recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma, Mantle-Cell | Mantle Cell Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bendamustin | Drug | — | UNRESOLVED |
| Rituximab | Drug | Rituximab | ALIAS |
| Zanubrutinib | Drug | Zanubrutinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ZBR
- interventionNames
- Drug: Zanubrutinib
- Drug: Rituximab
- Drug: Bendamustin
Primary outcomes (1)
- measure
- 2-year Progression-Free Survival
- timeFrame
- 2 years
- description
- 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.
Secondary outcomes (4)
- measure
- ORR
- timeFrame
- End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=28 days]
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.