Expanded Access to Vodobatinib for Patients With Philadelphia Chromosome-Positive Chronic Myeloid Leukemia Who Have Not Responded to Previous Treatments
试验速览
- 阶段
- 不适用
- 状态
- Temporarily Not Available
- 试验地点
- 10
研究概览
简要总结
The main study (CLR_15_03) was terminated prematurely for non-safety reasons due to changes in the clinical treatment landscape and evolving regulatory considerations. To ensure continuity of care, post-trial access to vodobatinib was initiated in January 2024 for subjects who, in the judgment of their treating investigator, continued to derive clinical benefit and had no viable alternative treatment options.
Continued treatment and all aspects of medical care are determined and managed solely by the Principal Investigator/treating physician in accordance with local standard of care. Responsibility of the medical care rests with the Investigator, as agreed with the Sponsor.
Between January 2024 and January 2025, 29 subjects transitioned to post-trial access in compliance with applicable country-specific guidelines.
研究设计
- 研究类型
- Expanded Access
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In general, the inclusion and
排除标准
- •enlisted in the protocol of the CLR_15_03 study will be applicable.
- •Inclusion Criteria:
- •Subjects who previously received K0706 during the CLR_15_03 study.
- •Absence of any alternative therapies for the management of CML.
- •Willing and able to give written, and dated, informed consent.
- •Willing and able to comply with the scheduled visits.
- •Exclusion Criteria:
- •Presence of T315I.