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

April 11, 2026 updated by: Sun Pharma Advanced Research Company Limited

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.

Study Overview

Status

Temporarily not available

Conditions

Intervention / Treatment

Study Type

Expanded Access

Expanded Access Type

  • Individual Patients

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69373
        • Léon Bérard Center
  • Hungary
      • Debrecen, Hungary, 4032
        • University of Debrecen, Clinical Center Institute of Internal Medicine
  • India
      • Madurai, India
        • Meenakshi Mission Hospital and Research Centre
      • Navi Mumbai, India
        • Tata Memorial Centre, Advanced Centre for Treatment, Research and Education in Cancer
  • Italy
    • FC
      • Meldola, FC, Italy, 47014
        • IRCCS Romagnolo Institute for the Study of Tumors "Dino Amadori"
  • Romania
      • Bucharest, Romania
        • Colentina Clinical Hospital
      • Cluj-Napoca, Romania
        • Oncology Institute "Prof. Dr. Ion Chiricuță"
  • Spain
      • Madrid, Spain
        • Hospital Universitario 12 de octubre
  • United States
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Georgia Cancer Center at Augusta University
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • University of Utah Huntsman Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Pharma Advanced Research Company Limited

Collaborators

Please see Contacts/Locations for the different Principal Investigators for each patient.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

March 31, 2026

First Submitted That Met QC Criteria

March 31, 2026

First Posted (Actual)

April 8, 2026

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 11, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Expanded Access_CLR_15_03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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