ACALABRUTINIB for Chronic lymphocytic leukemia

Inclusion criteria

• {"criterion_text":"- 1. Written informed consent to participate in a clinical trial\n- 2. Age of patients over 18 years (women and men)\n- 3. Diagnosis of chronic lymphocytic leukemia untreated before the screening visit\n- 4. Presence of the following parameters during the screening period: - presence of monoclonal lymphocytes with co-expression of B cell markers (CD19, CD20 and CD23) and CD5 - prolymphocyte count <55% of peripheral blood lymphocyte count - absolute number of peripheral blood lymphocytes > 5000 /ul\n- 5. Presence of indications to start treatment according to the International Workshop on Chronic Lymphocytic Leukemia (the National Cancer Institute-Working Group (IWCLL) 2018.\n- 6. Laboratory test results: - absolute ANC number ≥0.75 x 109 /l or ≥0.50x109 /l in patients with documented bone marrow involvement; - platelet count ≥50x10 /l or ≥30x109 /l in patients with documented bone marrow involvement; - total bilirubin ≤1.5xULN; - AST, ALT, GGT in serum ≤3.0xULN; - estimated creatinine clearance (eGFR) ≥30 ml/min; - negative test result for HBsAg and HBcAg\n- 7. ECOG performance assessment score ≤2.\n- 8. Use of effective contraception by women of childbearing potential during treatment and at least 2 days after the last dose of acalabrutinib, 30 days after the last dose of venetoclax and 18 months after the last dose of obinutuzumab\n- 9. Use of an effective form of contraception by men during the study and 90 days after taking the last dose of the IMP\n- 10. Men must refrain from donating sperm during the study and for 90 days after taking the last dose of the study drug"}

Exclusion criteria

• {"criterion_text":"- 1. Any previous systemic treatment for CLL\n- 2. Diagnosis of CNS lymphoma or leukemia\n- 3. Diagnosed prolymphocytic leukemia or previous or suspected Richter's syndrome; \n- 4. Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenic purple\n- 5. Major surgery within 4 weeks before the first dose of IMP\n- 6. Previous malignancy, except appropriately treated melanoma arising from malignant lentigo, non-melanoma skin cancer, cervical cancer “in situ”, or other treated malignancy without evidence of active disease >3 years prior to screening and at low risk of recurrence\n- 7. Serious cardiovascular disease, e.g., uncontrolled or symptomatic arrhythmia, congestive heart failure, or myocardial infarction within 6 months before study entry, or any New York Heart Association Functional Classification class 3 or 4 heart disease or QTc >480 msec before entering the study\n- 8. Previous stroke or intracranial hemorrhage within 6 months before randomization;\n- 9. Current or planned anticoagulant treatment with warfarin or vitamin K antagonists within 7 days of the first dose of the study drug\n- 10. Current or planned treatment with proton pump inhibitors\n- 11. Current or planned treatment with a strong CYP3A inhibitor/inducer\n- 12. Presence of a gastrointestinal ulcer diagnosed by endoscopy within 3 months before the screening visit\n- 13. history of HIV infection\n- 14. History of bleeding disorders\n- 15. The presence of contraindications to use of IMP according to Summary of Product Characteristics\n- 16. Lack of full legal capacity\n- 17. Lack of possibility to understand the purpose"}

Primary endpoints

• {"endpoint_text":"- Primary endpoint Progression-free survival (PFS), defined as the time from randomization to progression or death, a clinically important endpoint.","definition_or_measurement_approach":"Progression-free survival (PFS), defined as the time from randomization to progression or death."}

Secondary endpoints

• {"endpoint_text":"- Secondary endpoints Response to treatment (including MRD)\n- time to next line of treatment.\n- The amount of change in quality of life.\n- Treatment safety based on the assessment of adverse events.\n- Overall survival is defined as the time from randomization to death from any cause.","definition_or_measurement_approach":"Response to treatment (including MRD) - method not specified in endpoints (MRD referenced). Time to next line of treatment - measured as time from randomization to start of next therapy. Change in quality of life - measured using EORTC QLQ-C30, EQ-5D and FACIT-Fatigue questionnaires (per secondary objectives). Treatment safety - based on assessment and reporting of adverse events. Overall survival (OS) - defined as time from randomization to death from any cause."}

Poland

Earliest CTIS Part Ii Submission Date

29-02-2024

Latest Decision Or Authorization Date

18-07-2025

Processing Time Days

505

Number Of Sites

7

Number Of Participants

72

Primary sponsor

Full Name

Specjalistyczny Szpital Im. Dra Alfreda Sokolowskiego

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Poland

Third parties

• {"country":"","full_name":"Agencja Badań Medycznych","duties_or_roles":"Monetary support","organisation_type":""}