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Leukemia drug holiday: study finds many can stop imatinib without relapse

NCT ID NCT01343173

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 31, 2026 · Updated 1 time

Summary

This study looked at 220 adults with chronic myeloid leukemia who had been in deep remission for at least two years while taking imatinib. Researchers wanted to see if stopping the drug would cause the cancer to come back. They found that many patients stayed in remission after stopping, and they identified factors that help predict who can safely stop treatment without relapse.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 220 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2011

Finished

May 2017

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: * 18 years and older. * Chronic myeloid leukaemia in chronic or accelerated phase under treatment with imatinib for at least 3 years. * Complete molecular remission under treatment with imatinib for at least 2 years. * HIV serology negative and absence of chronic hepatitis B or C. * Molecular monitoring according to the international recommendations before the beginning of the study * For the women old enough to procreate, method of effective contraception * All patients must be informed of the investigational nature of this study and must sign and give written informed consent. Exclusion Criteria: * Under 18 years old. * Pregnant at the inclusion's time. * Hospitalized patients without consent. * Adults under law protection or without ability to assent. * Previous or planned allogeneic stem cell transplantation. * HIV serology positive or chronic hepatitis B or C. * Interfering treatment (corticosteroids, immunosuppressors, chemotherapy, radiotherapy).

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Conditions

The condition(s) this trial relates to.

Bronchiolitis Obliterans Syndrome chronic myelogenous leukemia, BCR-ABL1 positive leukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive

As listed by the trial registrant

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

Chronic myeloid leukaemia

Contacts and locations

Locations

  • C.H.U. Brabois

    Vandœuvre-lès-Nancy, 54500, France

  • CH Annecy

    Annecy, France

  • CH Bretagne Atlantique

    Vannes, France

  • CH Régional de l'ILE DE LA REUNION/ Groupe Hospitalier Sud

    Saint-Pierre, France

  • CH Sud Francilien

    Corbeil-Essonnes, France

  • CH Valence

    Valence, France

  • CH Yves Le Foll

    Saint-Brieuc, France

  • CHR La Réunion

    Saint-Denis, 97405, France

  • CHU Bensançon

    Besançon, France

  • CHU Caen

    Caen, France

  • CHU Dupuytren

    Limoges, France

  • CHU Grenoble

    Grenoble, 38043, France

  • CHU Hôtel-Dieu

    Nantes, 44035, France

  • CHU de Nice - Hôpital Archet 1

    Nice, 06202, France

  • Centre Henri Becquerel

    Rouen, France

  • Centre Hospitalier - La Roche sur Yon

    La Roche-sur-Yon, 85025, France

  • Centre Hospitalier de Nevers

    Nevers, 58033, France

  • Centre Hospitalier de Versailles - Hôpital André Mignot

    Versailles, 78157, France

  • Hôpital Edouard Herriot

    Lyon, 69374, France

  • Hôpital Henri-Mondor

    Créteil, 94000, France

  • Hôpital Morvan

    Brest, 29285, France

  • Hôpital Necker-Enfants Malades

    Paris, 75743, France

  • Hôpital Pontchaillou

    Rennes, 35033, France

  • Hôpital Purpan

    Toulouse, 31059, France

  • Hôpital Saint Louis

    Paris, 75475, France

  • Hôpitaux civils de Colmar

    Colmar, 68000, France

  • Institut Bergonié

    Bordeaux, 33076, France

  • Institut Paoli Calmette

    Marseille, 13273, France

  • Lille University hospital - Hôpital Claude Huriez

    Lille, 59037, France

  • University Hospital Angers

    Angers, 49033, France

  • University Hospital Bordeaux, Hôpital du Haut Lévêque

    Pessac, 33604, France

  • University Hospital Poitiers - Hôpital Jean Bernard

    Poitiers, 86021, France