A Randomized, Multicenter, Open-Label, Non-Inferiority, Phase 3 Study of ACP-196 Versus Ibrutinib in Previously Treated Subjects with High Risk Chronic Lymphocytic Leukemia - ACE-CL-006

Acerta Pharma BV0 个研究点目标入组 60 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: Acerta Pharma BV
入组人数: 60

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 99（—）

入选标准

•1. Men and women >= 18 years of age.
•2. ECOG performance status of 0 to 2.
•3. Diagnosis of CLL that meets published diagnostic criteria (Hallek 2008):
•oMonoclonal B-cells (either kappa or lambda light chain restricted) that
•are clonally co-expressing >= 1 B-cell marker (CD19, CD20, or CD23) and
•oProlymphocytes may comprise <= 55% of blood lymphocytes.
•oPresence of >= 5 x 10^9 B lymphocytes/L (5000 µL) in the peripheral
•blood (at any point since diagnosis); this applies to CLL only.
•4. Must have >= 1 of the following high-risk prognostic factors:
•i. Presence of 17p del by central laboratory.
•ii. Presence of 11q del by central laboratory.
•5. Active disease meeting >= 1 of the following IWCLL 2008 criteria for
•requiring treatment:
•a. Evidence of progressive marrow failure as manifested by the development of,
•or worsening of, anemia (hemoglobin < 10 g/dL) and/or thrombocytopenia
•(platelets < 100,000/µL).
•b. Massive (ie, >= 6 cm below the left costal margin), progressive, or
•symptomatic splenomegaly
•c. Massive nodes (ie, >= 10 cm in the longest diameter), progressive, or
•symptomatic lymphadenopathy.
•d. Progressive lymphocytosis with an increase of > 50% over a 2-month period or
•a LDT of < 6 months. LDT may be obtained by linear regression extrapolation of
•ALC obtained at intervals of 2 weeks over an observation period of 2 to 3
•months. In subjects with initial blood lymphocyte counts of < 30 X 10^9/L
•(30,000/µL), LDT should not be used as a single parameter to define indication
•for treatment. In addition, factors contributing to lymphocytosis or
•lymphadenopathy other than CLL (eg, infections) should be excluded.
•e. Autoimmune anemia and/or thrombocytopenia that is poorly responsive to
•standard therapy.
•f. Constitutional symptoms documented in the subject*s chart with supportive
•objective measures, as appropriate, defined as >= 1 of the following
•disease-related symptoms or signs:
•i. Unintentional weight loss >= 10% within the previous 6 months before
•ii. Significant fatigue (ie, ECOG performance status 2 or worse; inability to
•work or perform usual activities).
•iii. Fevers > 100.5°F or 38.0°C for >= 2 weeks before Screening without evidence
•of infection.
•iv. Night sweats for > 1 month before Screening without evidence of infection.
•6. Must have received >= 1 prior therapies for CLL.
•8. Meet the following laboratory parameters:
•a. ANC >= 750 cells/µL (0.75 x 10^9/L) or >= 500 cells/µL (0.50 x 10^9/L) in
•subjects with documented bone marrow involvement, and independent of growth
•factor support 7 days before assessment.
•b. Platelet count >= 30,000 cells/µL (30 x 10^9/L) without transfusion support 7
•days before assessment. Subjects with transfusion-dependent thrombocytopenia
•are excluded.
•c. Serum AST/SGOT and ALT/SGPT <= 3.0 x ULN.
•d. Total bilirubin <= 1.5 x ULN.
•e. Estimated creatinine clearance (ie, eGFR using Cockcroft-Gault) >= 30 mL/min.
•9. Able to receive all outpatient treatment, all laboratory monitoring, and
另有 6 项未显示

排除标准

•1. Known CNS lymphoma or leukemia.
•2. Known prolymphocytic leukemia or history of, or currently suspected,
•Richter*s syndrome.
•3. Uncontrolled AIHA or ITP defined as declining hemoglobin or platelet count
•secondary to autoimmune destruction within the screening period or requirement
•for high doses of steroids (> 20 mg daily of prednisone daily or equivalent).
•4. Prior exposure to ibrutinib or to a BCR inhibitor (eg Btk or PI3 kinase or
•Syk inhibitors) or a BCL-2 inhibitor (eg, ABT-199).
•5. Received any chemotherapy, external beam radiation therapy, anticancer
•antibodies, or investigational drug within 30 days before first dose of study
•6. Corticosteroid use > 20 mg within 1 week before first dose of study drug,
•except as indicated for other medical conditions such as inhaled steroid for
•asthma, topical steroid use, or as premedication for administration of study
•drug or contrast. For example, subjects requiring steroids at daily doses > 20
•mg prednisone equivalent systemic exposure daily, or those who are administered
•steroids for leukemia control or white blood cell count lowering are excluded.
•7. Prior radio- or toxin-conjugated antibody therapy.
•8. Prior allogeneic stem cell or autologous transplant.
•9. Major surgery within 4 weeks before first dose of study drug.
•10. History of prior malignancy except for the following:
•a. Malignancy treated with curative intent and with no evidence of active
•disease present for more than 3 years before Screening and felt to be at low
•risk for recurrence by treating physician
•b. Adequately treated lentigo maligna melanoma without current evidence of
•disease or adequately controlled non-melanomatous skin cancer
•c. Adequately treated cervical carcinoma in situ without current evidence
•11. Significant cardiovascular disease such as uncontrolled or symptomatic
•arrhythmias, congestive heart failure, or myocardial infarction within 6
•months of screening, or any Class 3 or 4 cardiac disease as defined by
•the New York Heart Association Functional Classification, or QTc > 480
•msec at screening.
•12. Unable to swallow capsules or malabsorption syndrome, disease significantly
•affecting gastrointestinal function, or resection of the stomach or small bowel
•or gastric bypass, symptomatic inflammatory bowel disease, or partial or
•complete bowel obstruction.
•13. Uncontrolled active systemic fungal, bacterial, viral, or other infection
•(defined as exhibiting ongoing signs/symptoms related to the infection and
•without improvement, despite appropriate antibiotics or other treatment) or
•ongoing intravenous anti-infective treatment.
•14. Known history of infection with HIV.
•15. Serologic status reflecting active hepatitis B or C infection. Subjects
•with hepatitis B core antibody positive who are surface antigen negative or who
•are hepatitis C antibody positive will need to have a negative PCR result
•before randomization. Those who are hepatitis B surface antigen positive or
•hepatitis B PCR positive and those who are hepatitis C PCR positive will be
•16. History of stroke or intracranial hemorrhage within 6 months before
•randomization.
•17. History of bleeding diathesis (eg, hemophilia, von Willebrand disease).
•18. Requires or receiving anticoagulation with warfarin or equivalent vitamin K
•antagonists (eg, phenproco

研究者

发起方

Acerta Pharma BV

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