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)

Janssen-Cilag International NV0 个研究点目标入组 200 人开始时间: 2018年2月15日最近更新: 2024年2月26日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Janssen-Cilag International NV
入组人数: 200

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 clinical trial of medicinal product

入排标准

性别: All

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 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]), 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).
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 180
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

排除标准

•1. Prior anti-leukemic therapy for CLL or SLL.
•2. Presence of del17p or known TP53 mutation detected at a threshold of >10% variable allele frequency (VAF).
•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 International NV

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