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Venetoclax and Ibrutinib in Treating in Participants With Chronic Lymphocytic Leukemia and Ibrutinib Resistance Mutations

StatusActive, Not Recruiting
PhasePhase 2
Started2019-03-26
View on ClinicalTrials.gov ↗

Amendment history

2026-02-04
Study Identification, Study Status, Oversight v10
Primary completion date2025-12-31→2026-12-31
Completion date2025-12-31→2026-12-31
Study titlerevised
Venetoclax and Ibrutinib in Treating in Participants withWith Chronic Lymphocytic Leukemia and Ibrutinib Resistance Mutations
2025-01-02
Study Identification, Study Status, Oversight v9
Primary completion date2024-12-31→2025-12-31
Completion date2024-12-31→2025-12-31
Study titlerevised
Venetoclax and Ibrutinib in Treating in Participants Withwith Chronic Lymphocytic Leukemia and Ibrutinib Resistance Mutations
2023-11-07
Study Status v8
Primary completion date2022-12-31→2024-12-31
Completion date2022-12-31→2024-12-31
2022-04-08
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v7
Trial statusRecruiting→Active, Not Recruiting
Study sitesdetails revised at 1 of 1 site
2021-10-29
Study Identification, Study Status, Sponsor/Collaborators, Contacts/Locations v6
Primary completion date2021-02-28→2022-12-31
Completion date2021-02-28→2022-12-31
Start date2019-02-27→2019-03-26
Collaborators-31 characters
National Cancer Institute (NCI)
Show 5 earlier versions
2019-03-26
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations, IPDSharing v5
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2019-04-30→confirmed 2019-02-27
Study sitesdetails revised at 1 of 1 site
2019-02-21
Study Status v4
Start date2019-01-31→2019-04-30
2018-12-06
Study Status v3
Start date2018-09-01→2019-01-31
2018-07-17
Study Status, Contacts/Locations v2
Start date2018-06-01→2018-09-01
Study sitescontacts updated at 1 of 1 site
2018-05-01
Study Status, Eligibility v1
Eligibility criteriarevised
[...] astern Cooperative Oncology Group (ECOG) performance status ?≤ 2 Currently taking ibrutinib and first took ibrutinib > 3 m [...] hs ago Presence of a known ibrutinib resistance mutation at ?≥ 4% variant allele frequency OR < 4% with two separate measu [...] uncontrolled autoimmune cytopenias are excluded Hemoglobin ?≥ 8 g/dL Absolute neutrophil count (ANC) ? ≥ 1,000/mm^3 Platelets ?≥ 40,000/mm^3 Prothrombin time/partial thromboplastin time (PT/PTT) ? ≤ 1.5 x upper limit of normal (ULN) (unless receiving anticoagulation) Total bilirubin ? ≤ 1.5 x ULN (excepting Gilbert?'s syndrome) Aspartate aminotransferas [...] [...]
2018-04-30
Original filing
This phase II trial studies how well venetoclax and ibrutinib work in treating participants with chronic lymphocytic leukemia and have developed genetic mutations after previously being treated with ibrutinib. Venetoclax and ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Trial Details
NCT Number NCT03513562
Lead Sponsor Ohio State University Comprehensive Cancer Center
Conditions Chronic Lymphocytic Leukemia, Ibrutinib Resistance
Enrollment 28 participants
Start Date 2019-03-26
Primary Completion 2026-12-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-02-06