Discontinuation of TyrosIne Kinase Inhibitors (TKI) in Chronic Myeloid Leukemia (CML) and Impact on the Immune System

Launched by POITIERS UNIVERSITY HOSPITAL · Feb 21, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how to safely stop treatment with a type of medication called tyrosine kinase inhibitors (TKIs) in patients with chronic myeloid leukemia (CML). TKIs have greatly improved the lives of CML patients, but they often come with side effects, and many patients would like to stop taking them permanently if possible. The trial aims to find out whether gradually reducing the TKI dose before stopping completely leads to better outcomes compared to stopping the medication suddenly after a maintenance period. Researchers will compare the health of participants over 24 months and look at certain immune cells to see how the body responds to the different ways of stopping treatment.

Eligible participants for this trial are adults aged 18 and older who have been diagnosed with a specific type of CML and have been on TKI treatment for several years without major changes to their dosage recently. Participants will need to have a confirmed deep molecular response, which means the treatment has been very effective for them. Those who join the trial can expect to be randomly placed in one of two groups: one will stop treatment suddenly, while the other will gradually reduce their dose first. It’s important to note that this trial is currently recruiting participants, and those interested will need to meet specific criteria and sign consent forms before joining.

Gender

ALL

Eligibility criteria

• 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