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Acalabrutinib in Combination With Venetoclax for the Treatment of Refractory or Recurrent Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma, The AVENUE-2 Trial

StatusRecruiting
PhasePhase 2
Started2023-05-31
View on ClinicalTrials.gov ↗

Amendment history

2026-05-15
3 amendments v17-v19
3 re-verifications since 2025-05-27, no change to tracked fields
2024-11-15
Study Identification, Study Status, Study Description, Arms and Interventions, Eligibility v16
InterventionsAcalabrutinib (Drug), Venetoclax (Drug)→Acalabrutinib (Drug), Biospecimen Collection (Procedure), Bone Marrow Aspiration (Procedure), Bone Marrow Biopsy (Procedure), Computed…
Eligibility criteria+148 characters
[...] dose of acalabrutinib or venetoclax, whichever occurs later WilingWilling and able to participate in all required evaluations and pro [...] dures in this study protocol, including swallowing capsules or tablets without difficulty AbleAbility to understand the purpose and the risks of the study and pr [...] ithin 7 days of the first dose of study drug is prohibited. For patients receiving capsule formulation of acalabrutinib only: Requires treatment with proton pump inhibitors (eg, omeprazo [...] deficiency virus (HIV) or any active significant infection (ege.g,. bacterial, viral, or fungal) History of or ongoing c [...] [...]
Study description+169 characters
[...] he absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection, bone marrow aspiration and biopsy, and computed tomography (CT) or magnetic resonance imaging (MRI) throughout the trial. After completion of study treatment, patients are followed-up every 12 weeks and annually for 10 years.
Study title+20 characters
[...] t Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma, The AVENUE-2 Trial
2024-05-20
2 amendments v14-v15
2 re-verifications since 2023-11-21, no change to tracked fields
2023-06-09
Study Status v13
Start dateestimated 2023-06-08→confirmed 2023-05-31
2023-05-08
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v12
Trial statusNot Yet Recruiting→Recruiting
Start date2023-05-10→2023-06-08
Study sitesdetails revised at 1 of 1 site
Show 11 earlier versions
2023-04-03
Study Status v11
Start date2023-03→2023-05-10
2023-03-22
Study Status v10
Re-verified, no change to tracked fields
2023-03-03
Study Status v9
Start date2023-03-01→2023-03
2023-01-10
Study Status v8
Start date2023-01-01→2023-03-01
2022-09-02
Study Status v7
Start date2022-09-02→2023-01-01
2022-05-20
Study Status v6
Primary completion date2027-05-10→2027-08-10
Completion date2031-05-10→2031-08-10
Start date2022-06-02→2022-09-02
2022-05-02
Study Status v5
Start date2022-05-01→2022-06-02
2022-03-31
Study Status v4
Start date2022-03-31→2022-05-01
2022-02-28
Study Status v3
Start date2022-02-25→2022-03-31
2022-01-25
Study Status v2
Start date2022-01-23→2022-02-25
2021-12-23
Study Status v1
Start date2021-12-21→2022-01-23
2021-06-21
Original filing
This phase II trial is to evaluate the effects of acalabrutinib in combination with venetoclax in treating patients with chronic lymphocytic leukemia or small lymphocytic lymphoma that does not respond to treatment (refractory) or that has come back (recurrent). Acalabrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as venetoclax, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Given acalabrutinib and venetoclax may kill more cancer cells.
Trial Details
NCT Number NCT04941716
Lead Sponsor Fred Hutchinson Cancer Center
Collaborators: AstraZeneca
Conditions Recurrent Chronic Lymphocytic Leukemia, Recurrent Small Lymphocytic Lymphoma, Refractory Chronic Lymphocytic Leukemia, Refractory Small Lymphocytic Lymphoma
Enrollment 20 participants
Start Date 2023-05-31
Primary Completion 2027-08-10 (estimated)
Study Completion 2031-08-10 (estimated)
Updated on ClinicalTrials.gov 2026-05-18