EUCTR2012-000600-15-GB进行中（未招募）1 期
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.
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 578
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
- •Diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that meets protocol-defined criteria
- •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 or SLL following at least 1 prior line of systemic therapy consisting of at least 2 cycles of a chemotherapycontaining regimen
- •Eastern Cooperative Oncology Group Performance Status score of 0 or 1
- •Hematology and biochemical values within protocol defined limits
- •Agrees to protocol-defined use of effective contraception
- •Women of childbearing potential must have negative blood or urine pregnancy test at screening
- •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
排除标准
- •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 and required treatment 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 equivalent vitamin K antagonists or treatment with strong CYP3A4/5 inhibitors
- •Known history of human immunodeficiency virus or hepatitis C, or active infection with hepatitis B or C
- •Any uncontrolled active systemic infection or any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the patient's safety, interfere
- •with the absorption or metabolism of ibrutinib capsules, or put the study outcomes at undue risk
- •A woman who is pregnant or breast feeding, or a man who plans to father a child while enrolled in this study or within 3 months after the last dose of study drug
研究者
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