Expanded Access to Vodobatinib for Patients With Philadelphia Chromosome-Positive Chronic Myeloid Leukemia Who Have Not Responded to Previous Treatments

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.

Sex

All

Minimum age

18 Years

In general, the inclusion and exclusion criteria 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.