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Last-Resort leukemia drug made available to 29 patients

NCT ID NCT07517315

Disease control Sponsor: Sun Pharma Advanced Research Company Limited Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused) This study
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This program provides continued access to the drug vodobatinib for people with Philadelphia chromosome-positive chronic myeloid leukemia (CML) whose cancer has not responded to prior treatments. After the main study was stopped early for non-safety reasons, 29 patients who were still benefiting from the drug were allowed to keep receiving it. Their care is managed by their own doctors according to local standards.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
vodobatinib
What this could lead to
If successful, this could provide a treatment option for people with chronic myeloid leukemia who have not responded to other therapies.
What could go wrong
This is an expanded access program, not a formal trial, so results are limited. The main study was stopped early, and only 29 patients are included.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

chronic myelogenous leukemia, BCR-ABL1 positive Recurrence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

CML, refractory CML, relapsed

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    10 sites in 7 countries. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Colentina Clinical Hospital

    Bucharest, Romania

  • Georgia Cancer Center at Augusta University

    Augusta, Georgia, 30912, United States

  • Hospital Universitario 12 de Octubre

    Madrid, Spain

  • IRCCS Romagnolo Institute for the Study of Tumors "Dino Amadori"

    Meldola, FC, 47014, Italy

  • Léon Bérard Center

    Lyon, 69373, France

  • Meenakshi Mission Hospital and Research Centre

    Madurai, India

  • Oncology Institute "Prof. Dr. Ion Chiricuță"

    Cluj-Napoca, Romania

  • Tata Memorial Centre, Advanced Centre for Treatment, Research and Education in Cancer

    Navi Mumbai, India

  • University of Debrecen, Clinical Center Institute of Internal Medicine

    Debrecen, 4032, Hungary

  • University of Utah Huntsman Cancer Institute

    Salt Lake City, Utah, 84112, United States

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