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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05896007
Other study ID # Zana
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date July 13, 2023
Est. completion date December 31, 2025

Study information

Verified date September 2023
Source Ruijin Hospital
Contact Weili Zhao, Doctor
Phone +86-64370045
Email zwl_trial@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Participants will receive zanubrutinib in addition to first-line therapy consisting of rituximab and either MTX or TMZ. After treatment of 6 cycles with the new regimen, the patients achieving CR or PR would go on to receive zanubrutinib maintenance of 1 year (if tolerable).


Recruitment information / eligibility

Status Recruiting
Enrollment 29
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - 18 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/(minĀ·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


Related Conditions & MeSH terms


Intervention

Drug:
Zanubrutinib
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
Rituximab
375 mg/m^2 ivgtt, D0 of each 28-day cycle
Methotrexate
3.5 g/m^2 ivgtt, D1 of each 28-day cycle
Temozolomide
150 mg/m^2 ivgtt, D1-D5 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 Overall Response Rate (ORR) The ORR is defined as percentage of participants with overall response including complete response (CR), unconfirmed complete response (CRu) and partial response (PR), on the basis of investigator assessments, according to the 2005 Response Criteria of the International Primary CNS Lymphoma Collaborative Group (IPCG). Baseline up to data cut-off (up to approximately 2 years)
Secondary Complete Response (CR) Rate The CR rate is defined as the proportion of patients with CR/CRu according to the 2005 Response Criteria of the International Primary CNS Lymphoma Collaborative Group (IPCG). Baseline up to data cut-off (up to approximately 2 years)
Secondary Overall Survival (OS) Overall survival is defined as the time from the date of first treatment to the date of 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)
See also
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Recruiting NCT05167630 - Prognosis Factors in Patients With Primary Central Nervous System Lymphoma
Recruiting NCT04514393 - Ibrutinib With Methotrexate and Temozolomide for Patients With Newly Diagnosed Primary CNS Lymphoma Phase 2
Recruiting NCT04481815 - Rituximab Plus Methotrexate With or Without Lenalidomide in Treating Patients With Newly Diagnosed Primary Central Nervous System Lymphoma Phase 2
Active, not recruiting NCT04438044 - A Study to Evaluate ICP-022 in Patients With R/R PCNSL and SCNSL Phase 2
Active, not recruiting NCT03392714 - Bendamustine-based Combination Therapy for PCNSL Phase 2
Not yet recruiting NCT05021770 - Orelabrutinib in Combination With Thiotepa in Refractory and Relapsed Primary CNS Lymphoma Phase 1/Phase 2
Recruiting NCT05782374 - Real World Data on Ibrutinib Use in PCNSL Rel/Ref