A Randomized, Multicenter, Open-Label, Phase 3 Study to Compare the Efficacy and Safety of Acalabrutinib (ACP-196) in Combination with Venetoclax with and without Obinutuzumab Compared to Investigator’s Choice of Chemoimmunotherapy in Subjects with Previously Untreated Chronic Lymphocytic Leukemia Without del(17p) or TP53 Mutation (AMPLIFY) - ACE-CL-311 (AMPLIFY)

Acerta Pharma B.V.0 个研究点目标入组 984 人开始时间: 2024年5月16日最近更新: 2024年8月21日

适应症

试验速览

阶段: 1 期
状态: 招募中
发起方: Acerta Pharma B.V.
入组人数: 984

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: 18 至 65+（—）
性别: All

入选标准

•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

排除标准

•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.

研究者

发起方

Acerta Pharma B.V.

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