Zanubrutinib and Venetoclax in CLL (ZANU-VEN)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDana-Farber Cancer Institute
About this trial
This study is being done to test the effectiveness of zanubrutinib in combination with venetoclax in participants with previously treated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
Eligibility criteria
Qualifiers
Confirmed diagnosis of CLL or SLL as per 2018 International Workshop on CLL (IWCLL) criteria.
Participants must have relapsed after at least one prior line of therapy and must currently require therapy by 2019 IWCLL criteria.
For enrollment to Cohort A: Participants must be covalent BTK and BCL-2 inhibitor naïve. Participants who have received prior therapy with a covalent BTK or BCL-2 inhibitor are not eligible, including but not limited to prior treatment with ibrutinib or acalabrutinib.
For enrollment to Cohort B: Participants must have had prior treatment with a BTK inhibitor or a BCL-2 inhibitor, but not both, and must not have experienced disease progression as defined by iwCLL criteria while receiving therapy.
Disqualifiers
Known BTK C481X mutation.
For enrollment to Cohort B: participants who have received prior treatment with both a BTK inhibitor and BCL-2 inhibitor.
Hormonal therapy given in the adjuvant setting
Corticosteroid therapy (prednisone or equivalent ≤ 20 mg daily) is allowed as clinically warranted as long as the dose is stabilized at least for 7 days prior to initial dosing. Topical, inhaled, intra-articular, or ophthalmologic corticosteroids are permitted
Trial design
Treatments tested in this trial
- Venetoclax
- Zanubrutinib
Treatment groups
45 Participants
are divided into 3 treatment groupsSponsors and collaborators
Dana-Farber Cancer Institute
Lead sponsor
BeiGene
Collaborator
Source ClinicalTrials.gov