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

Phase 2

Recruiting

• Conditions: Lymphoma, Mantle-Cell
• Interventions: Drug: Zanubrutinib; Drug: Rituximab; Drug: Bendamustin

• Registration Number: NCT06136351
• Lead Sponsor: Ruijin Hospital

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) patients with newly diagnosed mantle cell lymphoma.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-25
• Status Verified: 2023-11
• Study First Submitted QC: 2023-11-14
• Study Start: 2023-11-15
• Study First Posted: 2023-11-18
• Last Update Submitted: 2023-11-24
• Last Update Posted: 2023-11-29
• Primary Completion: 2027-11-01
• Study Completion: 2027-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 23

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ZBR	Rituximab	-
ZBR	Bendamustin	-
ZBR	Zanubrutinib	-

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
CRR	End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=28 days]	Complete Remission Rate (CRR) is defined as the proportion of patients with CR
OS	Baseline up to data cut-off (up to approximately 2 years)	Overall survival (OS) refers to the time from receiving the first dose to death from any cause
Adverse Events	Baseline up to data cut-off (up to approximately 2 years)	Any harmful reaction that occurs during the treatment of a disease according to the normal usage and dosage of a drug, which is unrelated to the purpose of treatment.
ORR	End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=28 days]	Objective Remission Rate (ORR) is defined as the proportion of patients with complete remission (CR) and partial remission (PR)

Trial Locations

Locations (1)

Ruijin Hospital; 🇨🇳 Shanghai, Shanghai, China