A Study for Tyrosine Kinase Inhibitors Discontinuation

NCT02897245 | Unknown

• 1 other identifier: 12/22_aSTIM
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Keywords

Myelogenous; Chronic; BCR-ABL Positive

Outcome Measures

Primary Outcomes (1)

• Survival without loss of molecular response major (RMM BCR-ABL / ABL IS ≤ 0.1%)

  2 years

Secondary Outcomes (5)

• Treatment free survival molecular evolution in treatment discontinuation

  2 years

• Progression free survival

  2 years

• Overall survival

  2 years

• The rate of deep molecular response after restarting TKIs kinase

  2 years

• Withdrawal syndrome

  2 years

Study Arms (1)

Patient with intentionally stop

Other: No intervention

Interventions

No intervention OTHER

Patient with intentionally stop

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

These are patients with chronic myeloid leukemia treated with a tyrosine kinase inhibitor for which an intentional discontinuation was made since 2007 outside the framework of a prospective study

You may qualify if:

• Patient with Chronic Myelogenous leukemia
• mors than 18 years old
• intentionally stop treatment by tyrosine kinase inhibitor

You may not qualify if:

• non intentionally stop (adverse event)
• Stop for disease progression
• Death patients

Sponsors & Collaborators

• Versailles Hospital: lead

Study Sites (1)

CH Versailles

Le Chesnay, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 32614963 DERIVED

MeSH Terms

Conditions

Leukemia; Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study coordonnator

Study Record Dates

• First Submitted: August 19, 2016
• First Posted: September 13, 2016
• Study Start: December 1, 2012
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2022
• Last Updated: July 30, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)