Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 3
Poitiers University Hospital (Voir sur ClinicalTrials)
décembre 2023
décembre 2029
30 juillet 2024
Tyrosine kinase inhibitors (TKI) have revolutionized the management and prognosis of
chronic myeloid leukemia (CML). Daily treatment with TKI, which is necessary due to lack
of cure, is frequently associated with moderate, chronic and sometimes severe adverse
effects. The ability to permanently stop treatment with TKI has thus become a major goal
in CML to prevent the occurrence of adverse events, improve quality of life and reduce
the general cost of the treatment; we talk about Treatment Free Remission (TFR). It now
remains to be demonstrated in a comparative prospective study that a strategy of
de-escalation of the TKI treatment dose before treatment discontinuation optimizes TFR
results. At the same time, it is possible to reduce adverse reactions and improve the
quality of life of patients. In this context, the investigator propose to conduct a
randomized clinical trial including CML patients, allowing to compare the results of TFR
at 24 months between a sudden stop of treatment after a maintenance phase of dosage for
12 months and a de-escalation arm of dose (dosage reduced by 50%) for 12 months before
stopping. A secondary immunological translational objective of this project will be to
compare the quantitative and qualitative evolution of innate CD8 T cells between the 2
arms (abrupt cessation of ITK treatment versus progressive withdrawal) and look for a
predictive innate CD8 T cells blood signature at the time of stopping treatment of a
successful TFR in both arms.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CH DE VERSAILLES SITE ANDRE MIGNOT | Philippe ROUSSELOT, Dr | Contact (sur clinicalTrials) | |||
| CHI DE CRETEIL | Lydia ROY, Dr | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Léon Bérard - Lyon - France | Franck NICOLINI, Dr | Contact (sur clinicalTrials) | |||
| Ch Annecy - Annecy - France | Contact (sur clinicalTrials) | ||||
| Ch Bayonne - Bayonne - France | Fréderic BAUDUER, Dr | Contact (sur clinicalTrials) | |||
| CH Brive la Gaillarde - Brive-la-Gaillarde - France | Stéphane Girault, Dr | Contact (sur clinicalTrials) | |||
| Ch Chambery - Chambéry - France | Contact (sur clinicalTrials) | ||||
| Ch La Rochelle - La Rochelle - France | Emmanuel FLECK, Dr | Contact (sur clinicalTrials) | |||
| Ch Mont de Marsan - Mont-de-Marsan - France | Samia MADENE HAROUNE, Dr | Contact (sur clinicalTrials) | |||
| Ch Perigueux - Périgueux - France | Claire CALMETTE, Dr | Contact (sur clinicalTrials) | |||
| Chu Angers - Angers - France | Corentin ORVAIN, Dr | Contact (sur clinicalTrials) | |||
| Chu Brest - Brest - France | Jean Christophe IANOTTO, Dr | Contact (sur clinicalTrials) | |||
| Chu Lille - Lille - France | Valerie COITEUX, Dr | Contact (sur clinicalTrials) | |||
| CHU Limoges - Limoges - France | Amélie PENOT, Dr | Contact (sur clinicalTrials) | |||
| Chu Nancy - Nancy - France | Contact (sur clinicalTrials) | ||||
| Chu Nantes - Nantes - France | Viviane DUBRUILLE, Dr | Contact (sur clinicalTrials) | |||
| Chu Poitiers - Poitiers - France | José Miguel TORREGROSA DIAZ, Dr | Contact (sur clinicalTrials) | |||
| Chu Tours - Tours - France | Antoine MACHET, Dr | Contact (sur clinicalTrials) | |||
| Hopital Prive Du Confluent - Nantes - France | Contact (sur clinicalTrials) | ||||
| Oncopole Toulouse - Toulouse - France | Francoise HUGUET, Dr | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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