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European Stop Tyrosine Kinase Inhibitor Study

NCT01596114 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 868

Last updated 2021-11-05

No results posted yet for this study

Summary

The EURO-SKI is a multicenter open label, uncontrolled trial estimating the persistence of molecular remission in Chronic Myeloid Leukemia (CML) patients after stopping Tyrosine Kinase Inhibitor (TKI). Main goal is the assessment of the duration of major molecular response (MMR) or better after stopping TKI therapy.

Secondary goals include:

* Identification of clinical and biological factors affecting the persistence of complete molecular remission after stopping TKI (e.g. level of Complete molecular remission (CMR), risk score, duration of TKI treatment, type of TKI pretreatment)
* Evaluation of quality of life (QoL) in patients stopping TKI
* Evaluation of medico-economic impact of stopping TKI
* Estimating the number of patients in CMR who are eligible for stopping TKI therapy by setting up a screening log
* Time to recovery of CMR There will be no randomised comparison. Based on the experience of the STIM trial (Mahon et al., Lancet Onc 2010) we expect an overall six-month molecular-relapse-free survival probability of at least 40%. An interim analysis will be performed after a pilot phase where 200 patients have been observed for at least six months. Formally, it is planned to test the null hypothesis H0: Six-month molecular relapse-free survival probability P ≤ 40% against the alternative hypothesis H1: Six-month molecular-relapse-free survival probability P \> 40%. Eligible are adult CML patients in chronic phase on TKI treatment in CMR for at least one year (\> 4 log reduction of BCR-ABL transcripts on IS, TKI treatment for at least 3 years, confirmed by a PCR within a standardized CMR laboratory). Clinical and biological monitoring will be performed during 3 years: Associated scientific projects are performed. Recruitment period: 2 years; follow up: 3 years. Planned patient recruitment in main phase: n=500

Conditions

  • Chronic Myeloid Leukemia

Interventions

OTHER

Stopping treatment with TKI

stopping until loss of MMR

Sponsors & Collaborators

  • European LeukemiaNet

    lead NETWORK

Principal Investigators

  • Susanne Saussele, Prof. Dr. · Universitätsmedizin Mannheim, Universität Heidelberg

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-30
Primary Completion
2014-12-03
Completion
2019-12-31

Countries

  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Greece
  • Netherlands
  • Norway
  • Portugal
  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01596114 on ClinicalTrials.gov