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Leukemia drug breakthrough: study tests tapering strategy to free patients from daily pills

NCT ID NCT05753384

Disease control Sponsor: Poitiers University Hospital 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 This study
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 Results may not be published yet.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)
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This status has not been confirmed recently, so it may be out of date.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 looks at whether people with chronic myeloid leukemia (CML) can stop taking their daily targeted therapy (TKI) without the cancer coming back. It compares two approaches: stopping the drug suddenly after a year of normal dosing, versus slowly reducing the dose over a year before stopping. The goal is to see which method helps more patients stay in remission without needing medication, while also reducing side effects and improving quality of life.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

170 people

The number who actually took part.

Started

Dec 2023

Expected to finish

Dec 2029

An estimate. End dates often move.

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

Accepted

You do not need to have the condition being studied to take part.

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: * Patient ≥ 18 year-old. * Diagnosis of chronic phase CML according to WHO 2016 criteria with a typical BCR::ABL1 rearrangement (e13a2 or e14a2) * Duration of treatment by Imatinib ≥ 4 years / ITK2G ≥ 3 years /Imatinib and ITK2G ≥ 4 years and no change of TKI or decrease in dosage in the last 6 months prior to inclusion * Deep Molecular Response (DMR) duration ≥ 1 year * Absence of contraindication to the continuation of the same TKI for 12 months at the same dosage according to international recommendations nd the PCR of each TKI: Imatinib (≥ 300 mg/j) Dasatinib (≥ 50 mg/j) Nilotinib (≥ 300 mg/j) Bosutinib (≥ 200 mg/j) * Patient not participating in another interventional study for the duration of the interventional study * Sexually active men should use effective contraception when taking Dasatinib * Having an health insurance * Having signed the consent form Non-Inclusion Criteria: * Patients with progressive severe pathology of poor prognosis immediately compromising participation in the entire study and/or with uncontrolled chronic pathology * ECOG ≥ 3 * Prior resistance to TKI * Patients who have already experienced an attempt of TKI cessation * Patients with a malignant tumour that has been treated with chemotherapy within 2 months of inclusion or undergoing chemotherapy or that will be treated with post-inclusion chemotherapy * Protected person * Pregnant women or women of childbearing age without appropriate contraceptive measures

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Conditions

The condition(s) this trial relates to.

chronic myelogenous leukemia, BCR-ABL1 positive 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 leukemia Tyrosine kinase inhibitors

Contacts and locations

Locations

  • CH Brive la Gaillarde

    Brive-la-Gaillarde, France

  • CH Versailles

    Versailles, France

  • CHI Creteil

    Créteil, France

  • CHU Limoges

    Limoges, France

  • Centre Léon Bérard

    Lyon, France

  • Ch Annecy

    Annecy, France

  • Ch Bayonne

    Bayonne, France

  • Ch Chambery

    Chambéry, France

  • Ch La Rochelle

    La Rochelle, France

  • Ch Mont de Marsan

    Mont-de-Marsan, France

  • Ch Perigueux

    Périgueux, France

  • Chu Angers

    Angers, France

  • Chu Brest

    Brest, France

  • Chu Lille

    Lille, France

  • Chu Nancy

    Nancy, France

  • Chu Nantes

    Nantes, France

  • Chu Poitiers

    Poitiers, France

  • Chu Tours

    Tours, France

  • Hopital Prive Du Confluent

    Nantes, France

  • Oncopole Toulouse

    Toulouse, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.