2022-11-14
minor
Study Identification, Study Status, Sponsor/Collaborators, Study Description, Conditions, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v3
Study sites3→2
Study arms2→3
Eligibility criteria-463 characters
Inclusion Criteria:
Confirmed diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) as per 2018 International Workshop on CLL (iwCLLIWCLL) 2018 criteria.
Participants must have relapsed after at least on [...] prior line of therapy and must currently require therapy by iwCLL2019 2018IWCLL criteria.
For enrollment to Cohort A: participantsParticipants must be covalent BTK and BCL-2 inhibitor naïve.
Participant [...] ith ibrutinib or acalabrutinib.
For enrollment to Cohort B: participantsParticipants must have had prior treatment with a BTK inhibitor or a BCL [...] therapy.
For enrollme [...]
Secondary endpoints16 to 6 entries
Overall response Rate (ORR),
Complete response (CR),
Complete responseResponse (CR) with incomplete count recovery (CRi)Rate
Percentage of Bone marrow undetectable minimal residual disease (uMRD) in bone marrow with CR
Percentage of boneuMRD marrowin undetectable minimal residual disease with CRi
Percentage of Peripheralperipheral blood undetectable minimal residual disease
Progression-free survival (PFS)
Overall survival (OS) rates
Median time to MRD recurrence
Median time to re-treatment
Median time to next different therapy
The number and proportion of adverse events, graded as defined by C [...]
Study description-1,617 characters
This is an open-label, non-randomized phase 2 trial assessing the combination of zanubrutinib and venetoclax in adult participants with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have relapsed after at least one prior therapy.
The U.S. Food and Drug Administration (FDA) has approved zanubrutinib as a treatment for mantle cell lymphoma (MCL) but not previously treated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
The U.S. Food and Drug Administration (FDA) has approved venetoclax as a treatment op [...] Participants will receive study treatment [...] [...]
Study title+9 characters
Zanubrutinib +and Venetoclax in CLL/SLL (ZANU-VEN)
2022-09-19
minor
Study Status, Sponsor/Collaborators, Contacts/Locations v2
Lead sponsorJennifer R. Brown, MD, PhD→Dana-Farber Cancer Institute
Study sitescontacts updated at 2 of 3 sites
2022-03-16
notable
Not Yet Recruiting→Recruiting Study Status, Study Description, Eligibility, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2022-02→confirmed 2022-02-18
Eligibility criteria-4 characters
[...] as per International Workshop on CLL (iwCLL) 2018 criteria.17
Participants must have relapsed after at least one prior li [...] y and must currently require therapy by iwCLL 2018 criteria.17
For enrollment to Cohort A: participants must be covalent B [...]
Study description+37 characters
[...] ts.
Participants will receive study treatment for 15 months withinitially.
There theis an option for an additional 12 months of therapy at disease recurrence, if indicated by their treating physician.
Participants will [...]
Study sitesdetails revised at 3 of 3 sites