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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Venetoclax
DrugC4-15
Zanubrutinib
DrugC1-15
Treatment groups
45 Participants
are divided into 3 treatment groupsGroup A: Cohort A: BTKi and BCL2i naiveExperimental treatment 2 interventions
Group B: Cohort B: BTKi or BCL2i exposed without disease progressionExperimental treatment 2 interventions
Group C: Cohort C: BTKi exposed and with disease progressionExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Rate of undetectable minimal residual disease (uMRD)
Assessed by flow cytometry (FC)
Time frame
At the end of cycle 15 (each cycle is 28 days)Secondary outcomes
1
Overall response Rate (ORR)
Assessed by 2018 IWCLL criteria
Time frame
At the end of cycle 15 (each cycle is 28 days)2
Complete Response (CR) Rate
Assessed by 2018 IWCLL criteria
Time frame
At the end of cycle 15 (each cycle is 28 days)3
Percentage of undetectable minimal residual disease (uMRD) in bone marrow with CR
Assessed by flow cytometry (FC)
Time frame
At the end of cycle 15 (each cycle is 28 days)4
Percentage of uMRD in peripheral blood
Assessed by flow cytometry (FC)
Time frame
After cycle 15At the end of cycle 15 (each cycle is 28 days)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Dana-Farber Cancer Institute
Lead sponsor
BeiGene
Collaborator
Source ClinicalTrials.gov