Safety and Anti-leukemic Activity of Vodobatinib (K0706) for Treatment Refractory/Intolerant CML Failing ≥3 Prior Chronic Myeloid Leukemia Therapies

Overview

About this study

The purpose of this study is determine the safety, tolerability, pharmacokinetics and activity of K0706.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Willing and able to give written, and dated, informed consent.
  • Male or female aged ≥ 18 years.
  • Willing and able to comply with the scheduled visits.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
  • Subjects diagnosed with Ph+ CML-CP, Ph+ CML-AP, Ph+ CML-BP.

Exclusion Criteria:

  • Individual < 18 years.
  • Any major surgery, as determined by the Investigator, within 4 weeks of IMP administration.
  • Inability to undergo venipuncture and/or tolerate venous access.
  • Positive exclusion tests: urine pregnancy tests (if applicable), HIV, hepatitis B surface antigen, or hepatitis C virus.
  • Known or suspected history of significant drug abuse as judged by the Investigator.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Talha Badar, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

More information

Publications

Publications are currently not available
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CLS-20522394

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