CTIS2023-504599-10-00招募中1 期
A Multicenter, Open-Label, Phase 2 Study to Evaluate the Efficacy and Safety of VenetoclaxObinutuzumab Retreatment in Patients with Recurring Chronic Lymphocytic Leukemia - M20-356
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 75
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 65+（—）
- 性别
- All
入选标准
- •Subjects must voluntarily sign and date an informed consent, approved by an independent ethics committee (IEC)/institutional review board (IRB), prior to the initiation of any screening or study-specific procedures., Documented diagnosis of CLL that requires retreatment according to iwCLL criteria., Previously completed venetoclax + anti-CD20 antibody ± X (where X is any additional drug) regimen as 1L fixed duration therapy and achieved documented response, defined as CR, CRi, PR, or nPR. Subjects who stopped 1L therapy earlier but completed at least 9 months of therapy and had a documented clinical response may be eligible based on the investigator's discretion. In Cohort 1, a maximum of approximately 20 subjects who previously received rituximab in 1L may be enrolled; in Cohort 2, there is no maximum number of subjects who previously received rituximab., Patients who will not receive approved second-line therapies as assessed by the investigator and patient preference may be eligible for the study., a) For Cohort 1: More than 24 months between the last dose of venetoclax and progression requiring treatment after completion of 1L venetoclax + anti-CD20 antibody ± X treatment; b) for Cohort 2: 12- 24 months between the last dose of venetoclax and progression requiring treatment after completion of 1L venetoclax + anti-CD20 antibody ± X treatment., Subject has not received an intervening treatment for CLL after completing previous treatment with venetoclax + anti-CD20 antibody ± X., Subject has not discontinued prior venetoclax + anti-CD20 antibody ± X treatment due to PD during treatment., No active or uncontrolled autoimmune hemolytic anemia or immune thrombocytopenic purpura., No transformation of CLL to aggressive NHL (Richter's transformation or pro-lymphocytic leukemia).
排除标准
- 未提供
研究者
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