The main study (CLR_15_03) was terminated prematurely for non-safety reasons due tochanges in the clinical treatment landscape and evolving regulatory considerations. Toensure continuity of care, post-trial access to vodobatinib was initiated in January 2024for subjects who, in the judgment of their treating investigator, continued to deriveclinical benefit and had no viable alternative treatment options.Continued treatment and all aspects of medical care are determined and managed solely bythe Principal Investigator/treating physician in accordance with local standard of care.Responsibility of the medical care rests with the Investigator, as agreed with theSponsor.Between January 2024 and January 2025, 29 subjects transitioned to post-trial access incompliance with applicable country-specific guidelines.
Not Provided
Drug: K0706
Other Name: Vodobatinib
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.
Georgia Cancer Center at Augusta University
Augusta, Georgia, United States
University of Utah Huntsman Cancer Institute
Salt Lake City, Utah, United States
Léon Bérard Center
Lyon, France
University of Debrecen, Clinical Center Institute of Internal Medicine
Debrecen, 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, Italy
Colentina Clinical Hospital
Bucharest, Romania
Oncology Institute "Prof. Dr. Ion Chiricuță"
Cluj-Napoca, Romania
Hospital Universitario 12 de Octubre
Madrid, Spain
Not Provided