Zanubrutinib Monotherapy in Relapsed/Refractory Central Nervous System Lymphoma

NCT05117814 | Unknown

• 1 other identifier: BGB-3111-2001-IIT
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Zanubrutinib is a novel BTK inhibitor with proven activity in patients with various B-cell lymphomas addicted to the B-cell receptor signaling pathway.

Conditions

CNS Lymphoma

Keywords

CNSL

Outcome Measures

Primary Outcomes (1)

• Overall response rate (ORR)

  Based on the Investigator assessed CR and PR, with the enhanced CT scan, the cerebrospinal fluid (CSF) examination, and the ophthalmological examination.

  2 years

Secondary Outcomes (5)

• Time to response (TTR)

  2 years

• Duration of response (DOR)

  2 years

• The concentration of zanunbrutinib in CSF and plasma

  2 months

• Progression-free survival (PFS)

  2 years

• Treatment-related adverse events (TRAE)

  During zanubrutinib treatment until 30+/-7 days after discontinuation.

Other Outcomes (2)

• Overall survival (OS)

  4 years

• ctDNA

  2 years

Study Arms (1)

Zanubrtuinib

EXPERIMENTAL

Zanubrutinib 320mg Qd

Drug: Zanubrutinib

Interventions

Zanubrutinib DRUG

as long as 24 months or consolidated with ASCT or WBRT after achieving PR or CR

Also known as: BGB-3111, BRUKINSA®

Zanubrtuinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to understand and willing to sign a written informed consent document
• Men and woman at least 18 years of age on the day of consenting to the study
• Histologically documented DLBCL.
• Relapsed/refractory PCNSL or relapsed/refractory SCNSL
• Patients with parenchymal lesions must have unequivocal evidence of disease progression on imaging (MRI or the brain or head CT) prior to study enrollment. For patients with leptomeningeal disease only, CSF cytology must document lymphoma cells and/or imaging findings consistent with CSF disease prior to study enrollment.
• An ECOG performance status≤2
• Adequate bone marrow and organ function shown by:
• (1) Neutrophils ≥ 0.75 x 109/L independent of growth factor support within 7 days of study entry (2) Platelets ≥ 50 x 109/L independent of growth factor support or transfusion within 7 days of study entry (3) Creatinine clearance of ≥ 30 mL/min (4) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x upper limit of normal (ULN) (5) Bilirubin ≤ 1.5 x ULN (6) International normalized ratio ≤ 1.5 and activated partial thromboplastin time ≤ 1.5 x ULN.
• \. Recovered to grade 1 toxicity from prior therapy before the first dose of study drug 9. Agree to use highly effective methods of birth control during the period of therapy and for 3 months after the last dose of the study drug.

You may not qualify if:

• Patients with SCNSL actively receiving treatment for extra-CNS disease
• Concurrently using other approved or investigational antineoplastic agents
• Prior chemotherapy, targeted therapy, or radiation therapy within 4 weeks
• Prior exposure to a BTK inhibitor
• Concurrently using more than 8mg of dexamethasone daily or the equivalent
• History of other active malignancies within 2 years of study entry
• Major surgery within 4 weeks of screening or not recovered from the side effects of such surgery
• Known to have human immunodeficiency virus (HIV) infection
• Known to have a history of active or chronic infection with hepatitis C virus (HCV) or hepatitis B virus (HBV) as determined by serologic tests
• Active infection systemic including infections requiring oral or intravenous antimicrobials
• Currently active clinically significant cardiovascular disease
• QTcF \> 480 msecs or other significant electrocardiogram (ECG) abnormalities
• Unable to swallow capsules or disease significantly affecting gastrointestinal function
• Any life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could have compromised the patient's safety, or put the study at risk
• Required ongoing treatment with medication that are strong cytochrome P450, family 3, subfamily A (CYP3A) inhibitors or strong CYP3A inducers

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

MeSH Terms

Interventions

zanubrutinib

Study Officials

• Shenmiao Yang, MD

  Peking University Peoples' Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shenmiao Yang, MD

CONTACT

134399999810; yangshenmiao@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief of Hematology

Study Record Dates

• First Submitted: September 25, 2021
• First Posted: November 11, 2021
• Study Start: September 1, 2021
• Primary Completion: January 1, 2023
• Study Completion: July 1, 2025
• Last Updated: August 3, 2022

Record last verified: 2022-08

Locations

CN (1)