Randomized, Double-blind, Placebo-controlled Phase 3 Study of Ibrutinib, a Bruton's Tyrosine Kinase (BTK) Inhibitor, in Combination with Bendamustine and Rituximab (BR) in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma.

Janssen-Cilag International NV0 个研究点目标入组 578 人开始时间: 2012年8月9日最近更新: 2022年1月24日

适应症

试验速览

暂无简介。

•- Diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma
•-Active disease meeting at least 1 of the International Workshop on Chronic Lymphocytic Leukemia 2008 criteria for requiring treatment
•- Measurable nodal disease by computed tomography
•- Relapsed or refractory CLL following at least 1 prior line of systemic therapy consisting of at least 2 cycles of a chemotherapy-containing regimen
•- Eastern Cooperative Oncology Group Performance Status score of 0 or 1
•- Hematology and biochemical values within protocol-defined limits within 7 days prior to randomization
•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 174
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 406

•- Recent therapeutic interventions within 3 (chemotherapy/radiotherapy) to 10 weeks (immunotherapy)
•- Prior treatment with ibrutinib or other Bruton’s tyrosine kinase inhibitors or prior randomization in any other clinical study evaluating ibrutinib
•- The presence of deletion of the short arm of chromosome 17
•- Patients previously treated with a bendamustine-containing regimen who did not achieve a response or who relapsed within 24 months of treatment with that regimen
•- Patients for whom the goal of therapy is tumor debulking prior to stem cell transplant
•- Received a hematopoietic stem cell transplant
•- Known central nervous system leukemia/lymphoma or Richter’s transformation
•- Patients with uncontrolled autoimmune hemolytic anemia or autoimmune thrombocytopenia
•- Chronic use of corticosteroids
•- History of prior malignancy, except: malignancy treated with curative intent and with no known active disease present for >=3 years before randomization; adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; adequately treated cervical carcinoma in situ without evidence of disease
•- History of stroke or intracranial hemorrhage within 6 months prior to randomization; or clinically significant cardiovascular disease
•- Requires anticoagulation with warfarin or treatment with strong CYP3A4/5 or CYP2D6 inhibitors

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