AITIK = Discontinuation of Tyrosine Kinase Inhibitor in CML and Impact on the Immune System [France]

Study title

Discontinuation of Tyrosine Kinase Inhibitor in CML and Impact on the Immune System

Scientific title

Discontinuation of TyrosIne Kinase Inhibitors (ITK) in Chronic Myeloid Leukemia (LMC) and Impact on the Immune System: a Randomized Comparative Study of Two Therapeutic Strategies

Type of study

Treatment discontinuation trial

Phase

3

Current status

Recruiting

Other trial ID

ClinicalTrials.gov NCT05753384

What is the purpose of the study

This is a study to assess whether reducing the tyrosine kinase inhibitor dose before treatment discontinuation can lead to better rates of treatment-free remission (TFR) than stopping the tyrosine kinase inhibitor dose suddenly before treatment discontinuation.

What will happen during the study

In this study, participants will be randomly assigned to one of two treatment groups:

  • Group A: Patients will continue taking their tyrosine kinase inhibitor received at randomization at a 50% reduced dose.
  • Group B: Patients will continue taking their tyrosine kinase inhibitor received at randomization without changing the dose.

Then, at 12 months after randomization, patients in both groups will stop their tyrosine kinase inhibitor treatment. The treatment-free remission results at 24 months will be compared between the two groups.

Key inclusion criteria

This study includes patients of all sexes who:

  • are aged 18 years or older
  • have been diagnosed with chronic phase chronic myeloid leukemia (CP CML) according to WHO 2016 criteria with a typical BCR::ABL1 rearrangement
  • have received treatment with imatinib for at least 4 years / a second-generation TKI for at least 3 years and who have not had a change of TKI or decrease in dosage in the last 6 months prior to inclusion.
  • have had a deep molecular response for at least 1 year.

Further criteria apply. Please discuss these with your doctor or study staff.

Key exclusion criteria

This study does not include patients who:

  • have progressive severe conditions of poor prognosis immediately compromising participation in the entire study and/or with uncontrolled chronic conditions.
  • have an ECOG of 3 or higher.
  • have previously been resistant to a TKI.
  • have previously attempted to stop TKI treatment.
  • have a malignant tumour that has been treated with chemotherapy within 2 months of inclusion or is undergoing chemotherapy or that will be treated with chemotherapy after inclusion in this trial.

Further criteria may apply. Please discuss these with your doctor or study staff.

Estimated primary completion date

December 2028

Where can I find additional information

You can find a study description in the US register ClinicalTrials.gov. This is a database provided by the U. S. National Institutes of Health.

Study sponsor

Poitiers University Hospital

Scientific lead / contact

Dr. Emilie Cayssials-Caylus
Chu Poitiers

Principal investigator

Dr. José Miguel Torregrosa Diaz
Chu Poitiers

Study centers / principal investigators

France

CHU Angers
Angers
Principal Investigator: Dr. Corentin Orvain

CH Bayonne
Bayonne
Principal Investigator: Dr. Fréderic Bauduer

CHU Brest
Brest
Principal Investigator: Dr. Jean Christophe Ianotto

CHU Créteil
Créteil
Principal Investigator: Dr. Lydia Roy

CH La Rochelle
La Rochelle
Principal Investigator: Dr. Emmanuel Fleck

CHU Lille
Lille
Principal Investigator: Dr. Valerie Coiteux

CHU Limoges
Limoges
Principal Investigator: Dr. Amélie Penot

Centre Léon Berard
Lyon
Principal Investigator: Dr. Franck Nicolini

CH Mont de Marsan
Mont-de-Marsan
Principal Investigator: Dr. Samia Madene Haroune

CHU Nantes
Nantes
Principal Investigator: Dr. Viviane Dubruille

CHU Poitiers
Poitiers
Principal Investigator: Dr. José Miguel Torregrosa Diaz

CHU Périgueux
Périgueux
Principal Investigator: Dr. Claire Calmette

Oncopole Toulouse
Toulouse
Principal Investigator: Dr. Francoise Huguet

CHU Tours
Tours
Principal Investigator: Dr. Antoine Machet

CHU Versailles
Versailles
Principal Investigator: Dr. Philippe Rousselot