A Study for Tyrosine Kinase Inhibitors Discontinuation

Leukemia Clinical Trial

— A-STIM  

Official title:

An Observational Study for CML Patients Who Discontinued Tyrosine Kinase Inhibitors Intentionally After Achieving a Deep Molecular Response

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02897245
• Other study ID #: 12/22_aSTIM
• Status: Recruiting
• Start date: December 2012
• Est. completion date: December 2022

Study information

• Verified date: July 2018
• Source: Versailles Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2022
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Leukemia

Intervention

Other:
• No intervention

Locations

Country	Name	City	State
France	CH Versailles	Le Chesnay

Sponsors (1)

Lead Sponsor	Collaborator
Versailles Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival without loss of molecular response major (RMM BCR-ABL / ABL IS = 0.1%)		2 years
Secondary	Treatment free survival molecular evolution in treatment discontinuation		2 years
Secondary	Progression free survival		2 years
Secondary	Overall survival		2 years
Secondary	The rate of deep molecular response after restarting TKIs kinase		2 years
Secondary	Withdrawal syndrome		2 years