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

Lymphoma, Mantle-Cell Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06136351
• Other study ID #: ZBR-01
• Status: Recruiting
• Phase: Phase 2
• Start date: November 15, 2023
• Est. completion date: November 1, 2027

Study information

• Verified date: November 2023
• Source: Ruijin Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 23
• Est. completion date: November 1, 2027
• Est. primary completion date: November 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Mantle-Cell

Intervention

Drug:
• 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

Locations

Country	Name	City	State
China	Ruijin Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	2-year Progression-Free Survival	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.	2 years
Secondary	ORR	Objective Remission Rate (ORR) is defined as the proportion of patients with complete remission (CR) and partial remission (PR)	End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=28 days]
Secondary	CRR	Complete Remission Rate (CRR) is defined as the proportion of patients with CR	End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=28 days]
Secondary	OS	Overall survival (OS) refers to the time from receiving the first dose to death from any cause	Baseline up to data cut-off (up to approximately 2 years)
Secondary	Adverse Events	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.	Baseline up to data cut-off (up to approximately 2 years)