CNS LymphomaNCT05117814
Zanubrutinib Monotherapy in Relapsed/Refractory Central Nervous System Lymphoma
A study testing Zanubrutinib in people with CNS Lymphoma, run by Peking University People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CNS Lymphoma
- What is being tested?
- Zanubrutinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Sep 2021to Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Adequate bone marrow and organ function shown by:
- 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.
- 8. 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.
Who cannot join
- 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
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- 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
- History of stroke or intracranial hemorrhage within 6 months prior to enrollment
- Inability to comply with study procedures
- Pregnant or lactating women
- Prior allogenic hematopoietic stem cell transplantation (autologous stem cell transplant is NOT an exclusion)
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Shenmiao Yang, MD
About this study
Zanubrutinib is a novel BTK inhibitor with proven activity in patients with various B-cell lymphomas addicted to the B-cell receptor signaling pathway.
Read the detailed description
Studies involving gene expression profiling and next generation sequencing have demonstrated that CNS lymphomas mostly are of the ABC-subtype and harbor mutations that reinforce BCR signaling. Ibrutinib, as the first BTK inhibitor, showed substantial activity in patients with R/R PCNSL and R/R SCNSL. Zanubrutinib is a novel BTK inhibitor with proven activity in patients with various B-cell lymphomas addicted to the B-cell receptor signaling pathway. In addition, pharmacological studies demonstrated the free drug exposure of zanubrutinib at 160 mg BID is roughly 10 times that of ibrutinib at 560 mg QD, and penetration into the CNS by zanubrutinib and ibrutinib is similar, suggesting the potential activity of zanubrutinib in the treatment of CNS lymphomas. However, the outcome of R/R PCNSL and R/R SCNSL patients treated with zanubrutinib monotherapy is still unclear.
- Conditions
- CNS Lymphoma
- Being tested
- Zanubrutinib
- Keywords
- CNSL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZanubrutinibDrug
Also called BGB-3111, BRUKINSA®
as long as 24 months or consolidated with ASCT or WBRT after achieving PR or CR
| Study group | Role | What they receive |
|---|---|---|
| Zanubrtuinib | Experimental | Zanubrutinib 320mg Qd Receives: Drug: Zanubrutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (5)
Time to response (TTR)
Time from the first dose of zanubrutinib to the first assessment of >=PR
Measured: 2 years
Duration of response (DOR)
Time from the first assessment of >=PR to symptom, CT scan, and/ or CSF confirmed progressive disease (PD)
Measured: 2 years
The concentration of zanunbrutinib in CSF and plasma
The concentration of zanunbrutinib in CSF and plasma 2 hours after taking the drug
Measured: 2 months
Progression-free survival (PFS)
The time from the first dose to PD or death whichever occurs earlier.
Measured: 2 years
Treatment-related adverse events (TRAE)
Adverse events during zanubrutinib treatment.
Measured: During zanubrutinib treatment until 30+/-7 days after discontinuation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study startSep 2021 (estimated)
- Primary completionJan 2023 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CNS LymphomaStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiao-Jun Huang, Peking University People's Hospital
- Investigators
- Shenmiao Yang, MD, Principal investigator, Peking University Peoples' Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05117814
- Sponsor's protocol ID
- BGB-3111-2001-IIT
- Status last verified
- Aug 2022
- First submitted
- 25 Sep 2021
- Last updated
- 3 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zanubrutinib Monotherapy in Relapsed/Refractory Central Nervous System Lymphoma
- ClinicalTrials.gov ID
- NCT05117814
- Acronym / sponsor ID
- BGB-3111-2001-IIT
- Conditions
- CNS Lymphoma
- Keywords
- CNSL
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- Sep 2021 (estimated)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 11 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Zanubrutinib is a novel BTK inhibitor with proven activity in patients with various B-cell lymphomas addicted to the B-cell receptor signaling pathway.
Detailed description
Studies involving gene expression profiling and next generation sequencing have demonstrated that CNS lymphomas mostly are of the ABC-subtype and harbor mutations that reinforce BCR signaling. Ibrutinib, as the first BTK inhibitor, showed substantial activity in patients with R/R PCNSL and R/R SCNSL. Zanubrutinib is a novel BTK inhibitor with proven activity in patients with various B-cell lymphomas addicted to the B-cell receptor signaling pathway. In addition, pharmacological studies demonstrated the free drug exposure of zanubrutinib at 160 mg BID is roughly 10 times that of ibrutinib at 560 mg QD, and penetration into the CNS by zanubrutinib and ibrutinib is similar, suggesting the potential activity of zanubrutinib in the treatment of CNS lymphomas. However, the outcome of R/R PCNSL and R/R SCNSL patients treated with zanubrutinib monotherapy is still unclear.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zanubrtuinib | Experimental | Drug: ZanubrutinibZanubrutinib 320mg Qd |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZanubrutinibAlso: BGB-3111, BRUKINSA®as long as 24 months or consolidated with ASCT or WBRT after achieving PR or CR | Drug | Zanubrtuinib |
Primary outcome
Overall response rate (ORR)
Time frame: 2 years
Based on the Investigator assessed CR and PR, with the enhanced CT scan, the cerebrospinal fluid (CSF) examination, and the ophthalmological examination.
5 secondary outcomes
Time to response (TTR)
Time frame: 2 years
Duration of response (DOR)
Time frame: 2 years
The concentration of zanunbrutinib in CSF and plasma
Time frame: 2 months
Progression-free survival (PFS)
Time frame: 2 years
Treatment-related adverse events (TRAE)
Time frame: During zanubrutinib treatment until 30+/-7 days after discontinuation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shenmiao Yang, MD principal investigator
Peking University Peoples' Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zanubrutinib in people with CNS Lymphoma, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shenmiao Yang, MD (134399999810, yangshenmiao@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (ORR) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2022.