A Study for Tyrosine Kinase Inhibitors Discontinuation

• Conditions: Leukemia
• Interventions: Other: No intervention

• Registration Number: NCT02897245
• Lead Sponsor: Versailles Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2016-08-19
• Study First Submitted QC: 2016-09-12
• Study First Posted: 2016-09-13
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-27
• Last Update Posted: 2018-07-30
• Primary Completion: 2020-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient with intentionally stop	No intervention	-

Primary Outcome Measures

Name	Time	Method
Survival without loss of molecular response major (RMM BCR-ABL / ABL IS ≤ 0.1%)	2 years

Secondary Outcome Measures

Name	Time	Method
Treatment free survival molecular evolution in treatment discontinuation	2 years
Progression free survival	2 years
Overall survival	2 years
Withdrawal syndrome	2 years
The rate of deep molecular response after restarting TKIs kinase	2 years

Trial Locations

Locations (1)

CH Versailles; 🇫🇷 Le Chesnay, France