Stopping Tyrosine Kinase Inhibitors in Chronic Myeloid Leukemia and Its Effects on the Immune System
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
This study is testing whether stopping tyrosine kinase inhibitors suddenly or gradually can help people with chronic myeloid leukemia feel better and improve their immune system.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Poitiers University Hospital Academic / other |
| Drugs / interventions | Imatinib, Dasatinib, Nilotinib, Bosutinib, chemotherapy |
| Locations | 20 sites (Angers and 19 other locations) |
| Trial ID | NCT05753384 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with chronic phase CML who have maintained a deep molecular response for at least one year.
Not a fit: Patients with progressive severe pathology or those who have not met the specific treatment duration and response criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could allow CML patients to safely discontinue TKI treatment, reducing side effects and improving their quality of life.
How similar studies have performed: Other studies have explored treatment-free remission in CML, but this specific approach of de-escalation before discontinuation is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Angers and 19 other locations
- Chu Angers — Angers, France (Recruiting)
- Ch Annecy — Annecy, France (Active_not_recruiting)
- Ch Bayonne — Bayonne, France (Recruiting)
- Chu Brest — Brest, France (Recruiting)
- CH Brive la Gaillarde — Brive-la-Gaillarde, France (Recruiting)
- Ch Chambery — Chambéry, France (Active_not_recruiting)
- CHI Creteil — Créteil, France (Recruiting)
- Ch La Rochelle — La Rochelle, France (Recruiting)
- Chu Lille — Lille, France (Recruiting)
- CHU Limoges — Limoges, France (Recruiting)
- Centre Léon Bérard — Lyon, France (Recruiting)
- Ch Mont de Marsan — Mont-de-Marsan, France (Recruiting)
- Chu Nancy — Nancy, France (Active_not_recruiting)
- Chu Nantes — Nantes, France (Recruiting)
- Hopital Prive Du Confluent — Nantes, France (Active_not_recruiting)
- Chu Poitiers — Poitiers, France (Recruiting)
- Ch Perigueux — Périgueux, France (Recruiting)
- Oncopole Toulouse — Toulouse, France (Recruiting)
- Chu Tours — Tours, France (Recruiting)
- CH Versailles — Versailles, France (Recruiting)
Study contacts
- Study coordinator: Emilie Cayssials-Caylus, Dr
- Email: emilie.cayssials@chu-poitiers.fr
- Phone: c
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.