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Can a second-line drug help CML patients stay cancer-free without daily pills?

NCT ID NCT01774630

Disease control Sponsor: University Hospital, Bordeaux 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 This study
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 Results may not be published yet.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)
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This status has not been confirmed recently, so it may be out of date.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 study looked at 31 adults with chronic myeloid leukemia (CML) whose cancer came back after they stopped taking imatinib. They were given nilotinib, a more powerful targeted therapy, to see if it could make their cancer undetectable again and allow them to stop treatment once more. The goal was to measure how many patients remained relapse-free three years after starting nilotinib.

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.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

31 people

The number who actually took part.

Started

Apr 2013

Finished

Dec 2020

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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.

Inclusion Criteria: * Male and female patients * Patient participating to the STIM trials (including STIM, STIM2 et EURO-SKI) and with confirmed molecular relapse on two consecutive RQ PCR, after imatinib discontinuation * Still in chronic phase * Not yet treated for this relapse * At least 18 years old (no upper age limit) * SGOT and SGPT \< 2.5 UNL * Serum creatinin \< 2 UNL * No planned allogeneic stem cell transplantation * Signed informed consent * ECOG score 0 to 2 Exclusion Criteria: * Pregnancy, lactation * Prior or concurrent malignancy other than CML (exceptions to be mentioned) * Serious uncontrolled cardiovascular disease * Severe psychiatric/neurological disease (previous or ongoing) * Ongoing treatment at risk for inducing "torsades de pointe" * QTcF \> 450ms despite correction of predisposing factors (i.e electrolytes…) * Congenital long QTcF * No health insurance coverage

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Conditions

The condition(s) this trial relates to.

chronic myelogenous leukemia, BCR-ABL1 positive Leukemia, Myelogenous, Chronic, BCR-ABL Positive Recurrence

As listed by the trial registrant

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

Leukemia, myelogenous, chronic, BCR-ABL positive

Contacts and locations

Locations

  • CH Valence

    Valence, 26953, France

  • CH d'Annecy

    Pringy, 74374, France

  • CHU Angers

    Angers, 49033, France

  • CHU de Nice, Service Hématologie Clinique

    Nice, 06202, France

  • CHU de Toulouse, Service d'Hématologie

    Toulouse, 31059, France

  • Centre Hospitalier Lyon Sud, Service Hématologie

    Pierre-Bénite, 69495, France

  • Centre Hospitalier de Versailles - Hôpital André Mignot - Service de Médecine B

    Le Chesnay, 78157, France

  • Hôpital Haut Lévêque, Service Hématologie

    Pessac, 33604, France

  • Hôpital Pontchaillou

    Rennes, 35033, France

  • Institut Bergonié

    Bordeaux, 33076, France

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