Informations générales (source: ClinicalTrials.gov)
An Observational Study for CML Patients Who Discontinued Tyrosine Kinase Inhibitors Intentionally After Achieving a Deep Molecular Response
Observational
Versailles Hospital (Voir sur ClinicalTrials)
décembre 2012
décembre 2022
02 mai 2026
Treatment of Chronic Myeloid Leukemia (CML) has been revolutionized by the use of
tyrosine kinase inhibitors including imatinib mesylate (Gleevec, Novartis Laboratories).
Two other inhibitors of the BCR-ABL kinase are currently on the market in France,
nilotinib (Tasigna®, Novartis Laboratories) in the first and second-line treatment and
dasatinib (SPRYCEL®, Bristol-Myers Squibb Laboratories) in second line. Achieving a
complete molecular response (CMR) in patients with Chronic Myeloid Leukemia (CML) treated
with tyrosine kinase inhibitors may be currently regarded as the ultimate level of
reduction of residual disease. The pilot Stop Imatinib study has opened the way for a
french prospective study of stopping imatinib, the STIM study. The results of the STIM
study showed that almost 60% of patients exhibited molecular relapse, most frequently
within the first 6 months after discontinuation. The parameters that are statistically
associated with the loss of complete molecular response are the Sokal score at diagnosis
and the total duration of treatment with imatinib. Criteria to define molecular relapse
in treatment free remission patients are not well defined and validated. The aim of the
study is to validate the loss of major molecular response as a robust criteria for TKI
resumption. The patient's population will be CML patients who are offered to discontinue
therapy outside the STIM strial.
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 | Rousselot Philippe | Contact (sur clinicalTrials) | |||
Critères
Tous
- Patient with Chronic Myelogenous leukemia
- mors than 18 years old
- intentionally stop treatment by tyrosine kinase inhibitor
Exclusion Criteria:
- inclusion in a prospective study
- non intentionally stop (adverse event)
- Stop for disease progression
- Death patients