A Study for Tyrosine Kinase Inhibitors Discontinuation

NCT ID: NCT02897245

Last Updated: 2018-07-30

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2022-12-31

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.

Conditions

Leukemia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Patient with intentionally stop

No intervention

Intervention Type: OTHER

Interventions

No intervention

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Versailles Hospital

OTHER

Sponsor Role: lead

Responsible Party

Philippe ROUSSELOT

Study coordonnator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

CH Versailles

Le Chesnay, , France

Site Status: RECRUITING

Countries

France

Facility Contacts

Rousselot Philippe

Role: primary

phrousselot@ch-versailles.fr

References

Rousselot P, Loiseau C, Delord M, Cayuela JM, Spentchian M. Late molecular recurrences in patients with chronic myeloid leukemia experiencing treatment-free remission. Blood Adv. 2020 Jul 14;4(13):3034-3040. doi: 10.1182/bloodadvances.2020001772.

Reference Type: DERIVED

PMID: 32614963 (View on PubMed)

Other Identifiers

12/22_aSTIM

Identifier Type: -

Identifier Source: org_study_id