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This study is being done to test the effectiveness and safety of an investigational drug called acalabrutinib (ACP-196) when taken with already marketed drugs called Venetoclax and Obinutzumab in comparison to chemotherapy that is already in wide use for treatment of patients who have chronic lymphocytic leukemia and who have never been treated before.
EU CTIS ID: 2023-509349-11-00
What this study is testing
To evaluate the efficacy of acalabrutinib/venetoclax (AV; Arm A) compared with chemoimmunotherapy (fludarabine/cyclophosphamide/rituximab [FCR] or bendamustine/rituximab [BR]; Arm C)
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Men and women ≥18 years of age. 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0–2. 3. Diagnosis of CLL that meets published diagnostic criteria (Hallek et al. 2018): Monoclonal B-cells (either kappa or lambda light chain restricted) that are clonally co-expressing B-cell marker (CD19, CD20, and CD23) and CD5. Prolymphocytes may comprise <55% of blood lymphocytes. Presence of ≥5x109 B lymphocytes/L (5000/µL) in the peripheral blood (at any point since the initial diagnosis). 4. Active disease per IWCLL 2018 criteria that requires treatment (see Section 4.5.6). 5. Meet the following laboratory parameters: a) Adequate bone marrow function independent of growth factor or transfusion support within 1 week of Screening, as follows: i.ANC ≥750 cells/μL (0.75x109/L); ANC ≥500 cells/μL (0.50x109/L) in subjects with documented bone marrow involvement of CLL ii.Platelet count ≥50,000 cells/μL (50x109/L); platelet count ≥30,000 cells/μL (30x109/L) in subjects with documented bone marrow involvement of CLL b)Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5xULN. c)Total bilirubin ≤2xULN, unless directly attributable to Gilbert’s syndrome d)Estimated creatinine clearance of ≥50 mL/min, calculated using the formula of Cockcroft and Gault (if male, [140Age] x Mass (kg) / [72 x creatinine mg/dL]; multiply by 0.85 if female); estimated creatinine clearance of ≥70 mL/min for subjects selected by investigator to receive FCR in Arm C
You likely can't join if
- 1. Any prior CLL-specific therapies (except corticosteroid treatment administered due to necessary immediate intervention; within the last 10 days before start of study treatment, only dose equivalents up to 20 mg prednisone daily are permitted). 2. Detected del(17p) or TP53 mutation. 3. Transformation of CLL to aggressive non-Hodgkin lymphoma (NHL) (e.g., Richter’s transformation, PLL, or diffuse large B cell lymphoma [DLBCL]), or central nervous system (CNS) involvement by leukemia. 4. Any comorbidity or organ system impairment rated with a single CIRS score of 4 (excluding the eyes/ears/nose/throat/larynx organ system), or a total CIRS score of >6. 5. Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura. 6. History of confirmed progressive multifocal leukoencephalopathy (PML). 7. Received any investigational drug within 30 days before first dose of study drug. 8. Major surgical procedure within 30 days before the first dose of study drug. Note: If a subject had major surgery, they must have recovered adequately from any toxicity and/or complications from the intervention before the first dose of study drug. 9. History of prior malignancy that could affect compliance with the protocol, or interpretation of results, except for the following: •Curatively treated basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or carcinoma in situ of the prostate at any time prior to study. •Other cancers not specified above which have been curatively treated by surgery and/or radiation therapy from which subject is disease-free for ≥3 years without further treatment.
The study team makes the final eligibility decision.
Where it's taking place
- Israel
- China
- Canada
- Russian Federation
- Turkey
- Brazil
- United States
- Taiwan
- United Kingdom
- Australia
- Saudi Arabia
- Korea, Republic of
- South Africa
- Argentina
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Israel; China; Canada; Russian Federation; Turkey; Brazil and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.