Expanded Access to Vodobatinib for Patients With Philadelphia Chromosome-Positive Chronic Myeloid Leukemia Who Have Not Responded to Previous Treatments
1 other identifier
expanded_access
N/A
7 countries
10
Brief 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.
Trial Health
Trial Health Score
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10 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 31, 2026
CompletedFirst Posted
Study publicly available on registry
April 8, 2026
CompletedApril 15, 2026
April 1, 2026
March 31, 2026
April 11, 2026
Conditions
Interventions
Eligibility Criteria
You may not qualify if:
- 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.
- Presence of T315I.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Georgia Cancer Center at Augusta University
Augusta, Georgia, 30912, United States
University of Utah Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
Léon Bérard Center
Lyon, 69373, France
University of Debrecen, Clinical Center Institute of Internal Medicine
Debrecen, 4032, Hungary
Meenakshi Mission Hospital and Research Centre
Madurai, India
Tata Memorial Centre, Advanced Centre for Treatment, Research and Education in Cancer
Navi Mumbai, India
IRCCS Romagnolo Institute for the Study of Tumors "Dino Amadori"
Meldola, FC, 47014, Italy
Colentina Clinical Hospital
Bucharest, Romania
Oncology Institute "Prof. Dr. Ion Chiricuță"
Cluj-Napoca, Romania
Hospital Universitario 12 de Octubre
Madrid, Spain