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
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 / imatinib and a second-generation TKI for at least 4 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
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
Annecy – active, not recruiting
CH Bayonne
Bayonne
Principal Investigator: Dr. Fréderic Bauduer
CHU Brest
Brest
Principal Investigator: Dr. Jean Christophe Ianotto
CH Brive la Gaillarde
Brive la Gaillarde
Principal Investigator: Dr. Stéphane Girault
Chambery – active, not recruiting
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
Nancy – active, not recruiting
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