Clinical Research Directory

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.

A Phase 3 Study for the Efficacy and Safety of Radotinib in CP-CML Patients With Failure or Intolerance to Previous TKIs

In a multinational, multicenter, single-arm, open-label and Phase III Radotinib clinical study, chronic phase Ph+ chronic myeloid leukemia patients with failure or intolerance to previous TKIs therapy including Imatinib will be recruited. In this phase 3 study, 173 subjects are expected to be enrolled in a single arm with the administration of Radotinib 400mg twice daily, which includes 10% of dropout rate.