Expanded Access to Vodobatinib for Patients With Philadelphia Chromosome-Positive Chronic Myeloid… (NCT07517315) | Clinical Trial Compass
TEMPORARILY_NOT_AVAILABLENot Applicable
Expanded Access to Vodobatinib for Patients With Philadelphia Chromosome-Positive Chronic Myeloid Leukemia Who Have Not Responded to Previous Treatments
United States, France, Hungary
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Trial details
NCT IDNCT07517315
SponsorSun Pharma Advanced Research Company Limited