A Randomized, Open-label, Phase 3 study of the Combination of Ibrutinib plus Venetoclax versus Chlorambucil plus Obinutuzumab for the First-line Treatment of Subjects with Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) - 54179060CLL3011 / GLOW

Janssen-Cilag0 个研究点目标入组 23 人开始时间: 待定最近更新: 2024年9月9日

适应症

试验速览

阶段: 3 期
状态: 招募中
发起方: Janssen-Cilag
入组人数: 23

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. Adult subjects who are: , a. >=65 years old or, , b. 18 to 64 years old and
•have at least 1 of the following:, - Cumulative Illness Rating Scale (CIRS)
•score >6, - Creatinine clearance (CrCl) estimated <70 mL/min using the
•Cockcroft-Gault equation., 2. Diagnosis of CLL or SLL that meets iwCLL
•criteria. , 3. Active CLL/SLL requiring treatment per the iwCLL criteria: , a.
•Evidence of progressive marrow failure as manifested by the development of, or
•worsening of, anemia or thrombocytopenia or both;, b. Massive (ie, at least 6
•cm below the left costal margin) or progressive or symptomatic splenomegaly;,
•c. Massive nodes (ie, at least 10 cm in longest diameter) or progressive or
•symptomatic lymphadenopathy;, d. Progressive lymphocytosis with an increase of
•more than 50% over a 2-month period or lymphocyte doubling time of less than
•six months;, e. Constitutional symptoms, defined as 1 or more of the
•following:, - Unintentional weight loss >=10% within the previous 6 months prior
•to the start of screening;, - Significant fatigue (inability to work or perform
•usual activities);, - Fevers higher than 100.5°F or 38.0°C for 2 or more weeks
•without evidence of infection; , - Night sweats for more than 1 month without
•evidence of infection., 4. Measurable nodal disease (by computed tomography
•[CT]) is defined as at least one lymph node >;1.5 cm in longest diameter. ,
•5. ECOG Performance Status Grade <=2., 6. Adequate organ function defined as
•follows:, a. Absolute neutrophil count (ANC) >=750 cells/µL independent of
•growth factor support;, b. Platelets >=50,000 cells/µL independent of
•transfusion support for at least 7 days prior to randomization;, c. Hemoglobin
•>8.0 g/dL independent of transfusion support for at least 7 days prior to
•randomization;, d. Alanine aminotransferase (ALT) and aspartate
•aminotransferase (AST) <=3.0 x upper limit of normal (ULN);, e. Total bilirubin
•<=1.5 x ULN (unless due to Gilbert*s syndrome);, f. Estimated CrCl >=30 mL/min
•(Cockcroft-Gault equation).

排除标准

•1. Prior anti-leukemic therapy for CLL or SLL., 2. Presence of del17p or known
•TP53 mutation., 3. Major surgery within 4 weeks of first dose of study
•treatment. , 4. Known bleeding disorders (eg, von Willebrand*s disease or
•hemophilia)., 5. Central nervous system (CNS) involvement or suspected
•Richter*s syndrome., 6. An individual organ/system impairment score of 4 as
•assessed by CIRS, except for the eyes, ears, nose, throat, and larynx system,
•limiting the ability to receive treatment in this study., 7. Uncontrolled
•autoimmune hemolytic anemia or autoimmune thrombocytopenia (Coombs positivity
•in the absence of hemolysis is not an exclusion)., 8. Chronic use of
•corticosteroids more than 20 mg/day of prednisone or its equivalent within 7
•days of initiation of study treatment., 9. History of prior malignancy,
•except:, a. Malignancy treated with curative intent and with no known active
•disease present for >=24 months before randomization;, b. Adequately treated
•non-melanoma skin cancer or lentigo maligna without evidence of disease;, c.
•Adequately treated cervical carcinoma in situ without evidence of disease;, d.
•Malignancy, which is considered cured with minimal risk of recurrence., 10.
•Received live, attenuated vaccine within 4 weeks of randomization., 11. History
•of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, or
•hepatic condition that in the opinion of the investigator would adversely
•affect a subject*s participation in the study., 12. Currently active,
•clinically significant Child-Pugh Class B or C hepatic impairment according to
•the Child Pugh classification (see Attachment 4 Child-Pugh classification), 13.
•Uncontrolled active systemic infection or any life-threatening illness, medical
•condition, or organ system dysfunction which, in the investigator*s opinion,
•could compromise the subject*s safety or put the study outcomes at undue risk.,
•14. Inability or difficulty swallowing capsules/tablets, malabsorption
•syndrome, or any disease or medical condition significantly affecting
•gastrointestinal function.

研究者

发起方

Janssen-Cilag

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