CTIS2023-507557-16-00招募中1 期
An open label, multi-center asciminib roll-over study to assess long-term safety in patients who have completed a Novartis sponsored asciminib study and are judged by the investigator to benefit from continued treatment - CABL001A2001B
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 284
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
- •Participant with Ph+ CML or Ph+ ALL, currently receiving treatment with asciminib (single agent or in combination with imatinib, nilotinib or dasatinib) or imatinib, nilotinib or bosutinib alone within a Novartis-sponsored study, which has fulfilled the requirements for the primary objective and has completed treatment phase and, in the opinion of the Investigator, would benefit from continued treatment.
排除标准
- •Participant has been discontinued from parent study treatment due to any reason., Participant currently has unresolved toxicities of grade 3 or 4 reported as possibly related to study treatment in the parent study, which have: •not resolved to Grade 2 or lower within 42 days and /or require dose interruption for longer than 42 days for hematological toxicities, •not resolved to Grade 2 or lower within 28 days and /or require dose interruption for longer than 28 days in case of non-hematological toxicities., Participant’s ongoing treatment is currently approved and reimbursed at country level. In exceptional cases where the treatment is reimbursed at country but not individual level, please contact the Novartis Study Team., Pregnant or nursing (lactating) women., Women of child-bearing potential unless they are using highly effective methods of contraception.
研究者
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