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Acalabrutinib in Combination With Venetoclax or Obinutuzumab for the Treatment of Treatment-naive Chronic Lymphocytic Leukemia

StatusRecruiting
PhasePhase 2
Started2022-09-13
View on ClinicalTrials.gov ↗

Amendment history

2026-02-17
Study Status, Oversight v7
Primary completion date2025-12-31→2026-10-31
Completion date2025-12-31→2026-10-31
2025-05-28
Study Identification, Study Status, Contacts/Locations v6
Study sitescontacts updated at 1 of 1 site
Study titlerevised
Acalabrutinib in Combination withWith Venetoclax or Obinutuzumab for the Treatment of Treatment-naive Chronic Lymphocytic Leukemia
2024-09-19
Study Identification, Study Status, Sponsor/Collaborators, Oversight, Contacts/Locations v5
Primary completion date2024-12-31→2025-12-31
Completion date2024-12-31→2025-12-31
Study sitescontacts updated at 1 of 1 site
Study titlerevised
Acalabrutinib in Combination Withwith Venetoclax or Obinutuzumab for the Treatment of Treatment-naive Chronic Lymphocytic Leukemia
2024-03-14
Study Status, Eligibility v4
Eligibility criteria-282 characters
[...] me (aPTT) (in the absence of lupus anticoagulant) > 2 x ULN Requires treatment with proton pump inhibitors (e.g., omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole). Note: Subjects receiving proton pump inhibitors who switch to H2-receptor antagonists or antacids are eligible for enrollment to this study History of significant cerebrovascular disease/event, includ [...]
2023-11-02
Study Status v3
Primary completion date2023-12-31→2024-12-31
Show 2 earlier versions
2022-11-02
Study Status v2
Start dateestimated 2022-10-01→confirmed 2022-09-13
2022-08-29
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start date2022-06-01→2022-10-01
Study sitesdetails revised at 1 of 1 site
2022-04-13
Original filing
This phase II trial tests whether acalabrutinib in combination with venetoclax or obinutuzumab works to shrink tumors in patients with treatment-naive chronic lymphocytic leukemia . Acalabrutinib is also an inhibitor that works in the body to block the activation of certain cells that lead to the growth of cancerous B cells. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Obinutuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Giving acalabrutinib in combination with venetoclax or obinutuzumab may help ease symptoms, decrease the amount of cancer suggestive of improvement, prolonged disease-free remission and/or survival, and increased knowledge about cancer treatment in patients with chronic lymphocytic leukemia. Patients will be treated with acalabrutinib for 12 cycles, and then randomized to receive 6 cycles of acalabrutinib plus obinutuzumab or acalabrutinib plus venetoclax.
Trial Details
NCT Number NCT05336812
Lead Sponsor Ohio State University Comprehensive Cancer Center
Conditions Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Enrollment 52 participants
Start Date 2022-09-13
Primary Completion 2026-10-31 (estimated)
Study Completion 2026-10-31 (estimated)
Updated on ClinicalTrials.gov 2026-02-19