NL-OMON55465已完成3 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) - M15-550
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AbbVie B.V.
- 入组人数
- 8
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. 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
- •has clinically measurable disease (lymphocytosis > 5 × 10^9/L and/or palpable
- •and measurable nodes by physical exam and/or organomegaly assessed by physical
- •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:
- •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 bleeding episode within 3 months of Screening
- •hemoglobin >= 8.0 g/dL
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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