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

TEMPORARILY_NOT_AVAILABLE

Conditions studied: CML, Relapsed, CML, Refractory

In brief

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 facts

Study ID

NCT07517315

Run by

Sun Pharma Advanced Research Company Limited

Last updated by the study team

2026-04-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may 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.

You may not qualify if…

• Presence of T315I.

Where it is running

• 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

Full record on ClinicalTrials.gov

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