Expanded Access to Vodobatinib for Patients With Philadelphia Chromosome-Positive Chronic Myeloid Leukemia Who Have Not Responded to Previous Treatments
Part of paid clinical trials in Augusta, Georgia.
- Sponsor
- Sun Pharma Advanced Research Company Limited
- Study ID
- NCT07517315
- Status
- Temporarily Not Available
Conditions
- CML, Refractory
- CML, Relapsed
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- K0706 — DRUG
Study Details
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.
Key Dates
- Status verified
- Apr 2026
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Georgia Cancer Center at Augusta University | Augusta | Georgia | 30912 | - |
| University of Utah Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | - |