Zanubrutinib Combined With Rituximab and Chemotherapy for Newly-Diagnosed PCNSLBCL Patients Intolerant to HSCT

NCT05896007 | Unknown Phase 2 DMC

• 1 other identifier: Zana
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

This single-center, open, single-arm study aim to evaluate the efficacy and tolerability of a therapy introducing zanubrutinib on the basis of rituximab and methotrexate (MTX) \[or temozolomide (TMZ), if intolerant to MTX\] in treating patients newly diagnosed with primary CNS large B-cell lymphoma and intolerant to HSCT.

Conditions

PCNSL

Keywords

PCNSL; zanubrutinib

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Overall Response Rate (ORR)

  Baseline up to data cut-off (up to approximately 2 years)

• Complete Response (CR) Rate

  Baseline up to data cut-off (up to approximately 2 years)

• Overall Survival (OS)

  Baseline up to data cut-off (up to approximately 2 years)

• Adverse Events

  Baseline up to data cut-off (up to approximately 2 years)

Study Arms (1)

ZR-chemo

EXPERIMENTAL

Drug: Zanubrutinib, Rituximab and MTX (or TMZ, if intolerant to MTX)

Drug: Zanubrutinib; Drug: Rituximab; Drug: Methotrexate; Drug: Temozolomide

Interventions

Zanubrutinib DRUG

160 mg bid po, until disease progression, intolerance of drug toxicity or death, otherwise maintaining during the 1st year in 2 years of follow-up

Also known as: brukisa

ZR-chemo

Rituximab DRUG

375 mg/m\^2 ivgtt, D0 of each 28-day cycle

ZR-chemo

Methotrexate DRUG

3.5 g/m\^2 ivgtt, D1 of each 28-day cycle

ZR-chemo

Temozolomide DRUG

150 mg/m\^2 ivgtt, D1-D5 of each 28-day cycle

ZR-chemo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 80 years old;
• Histopathologically confirmed CD20 positive primary large B-cell lymphoma of the central nervous system (CNS) or primary vitreoretinal lymphoma according to the 5th edition of the World Health Organization (WHO) Classification of Haematolymphoid Tumours \[primary large B-cell lymphoma of the CNS previously named as primary diffuse large B-cell lymphoma (DLBCL) of the CNS in the revised 4th edition\];
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital

Shanghai, Shanghai Municipality, 20025, China

RECRUITING

MeSH Terms

Interventions

zanubrutinib; Rituximab; Methotrexate; Temozolomide

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Central Study Contacts

Weili Zhao, Doctor

CONTACT

+86-64370045; zwl_trial@163.com

Li Wang

CONTACT

+86-64370045; wl_wangdong@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: May 1, 2023
• First Posted: June 9, 2023
• Study Start: July 13, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 5, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)