Stopping Tyrosine Kinase Inhibitors in Chronic Myeloid Leukemia and Its Effects on the Immune System

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the possibility of discontinuing tyrosine kinase inhibitors (TKI) in patients with chronic myeloid leukemia (CML) to improve their quality of life and reduce treatment-related adverse effects. The study aims to compare the outcomes of treatment-free remission (TFR) between patients who suddenly stop TKI treatment and those who gradually reduce their dosage before stopping. By evaluating the immune system's response and the duration of deep molecular response, the trial seeks to establish a safe and effective strategy for TKI discontinuation. The ultimate goal is to demonstrate that a de-escalation approach can optimize TFR results and enhance patient well-being.

Why it matters

Who can join: the full rules

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

Where it's running

• Chu Angers
  Angers, France Recruiting
• Ch Bayonne
  Bayonne, France Recruiting
• Chu Brest
  Brest, France Recruiting
• CH Brive la Gaillarde
  Brive-la-Gaillarde, France Recruiting
• CHI Creteil
  Créteil, France Recruiting
• Ch La Rochelle
  La Rochelle, France Recruiting

Study contacts

• Study coordinator: Emilie Cayssials-Caylus, Dr
• Email: emilie.cayssials@chu-poitiers.fr
• Phone: c

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.