NCT07517315

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

• Status: Temporarily Not Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Sun Pharma Advanced Research Company Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

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.

Conditions

• CML, Relapsed
• CML, Refractory

Interventions

Type	Name	Description
DRUG	K0706

Timeline

• First posted: 2026-04-08
• Last updated: 2026-04-15

Locations

10 sites across 7 countries: United States, France, Hungary, India, Italy, Romania, Spain