EUCTR2015-003667-11-SE进行中（未招募）1 期
Open-Label, Single Arm, Phase 3B, Multi-Center Study Evaluating the Efficacy of Venetoclax (ABT 199) in Relapsed/Refractory Subjects with Chronic Lymphocytic Leukemia (CLL) (VENICE I)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 250
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. Age = 18 years.
- •2. Eastern Cooperative Oncology Group (ECOG) performance score of = 2.
- •3. Subject has relapsed/refractory disease (received at least one line of prior therapy).
- •4. Diagnosis of CLL that meets published 2008 Modified International Workshop on CLL National Cancer Institute – Working Group (IWCLL NCI-WG) Guidelines and:
- •has an indication for treatment according to the 2008 Modified IWCLL NCI-WG Guidelines
- •has clinically measurable disease (lymphocytosis > 5 × 10^9/L and/or palpable and measurable nodes by physical exam and/or organomegaly assessed by physical exam)
- •subjects with or without the 17p deletion or TP53 mutation are eligible
- •subjects who have received prior B-cell receptor inhibitor therapy are also eligible (up to 60 subjects total will be enrolled in the study)
- •5. Adequate bone marrow function as follows:
- •hemoglobin = 8.0 g/dL
- •platelets = 25,000/mm^3 without any of the following:
- •o transfusion support within 14 days of Screening
- •o evidence of mucosal bleeding
- •o known history of major bleeding episode within 3 months of 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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 150
排除标准
- •1. Subject has developed Richter's transformation or Prolymphocytic leukemia (PLL)
- •2. Subject has previously received venetoclax.
- •3. History of active malignancies other than CLL within the past 2 years prior to first dose of venetoclax, with the exception of:
- •adequately treated in situ carcinoma of the cervix uteri
- •adequately treated basal cell carcinoma or localized squamous cell carcinoma of the skin
- •previous malignancy confined and surgically resected (or treated with other modalities) with curative intent.
- •4. Active and uncontrolled autoimmune cytopenias (within 2 weeks prior to Screening), including autoimmune hemolytic anemia (AIHA) or idiopathic thrombocytopenic purpura (ITP), despite low dose corticosteroids.
- •5. Prior allogeneic stem cell transplant.
研究者
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