European Stop Tyrosine Kinase Inhibitor Study (EURO-SKI)

October 29, 2021 updated by: European LeukemiaNet

Multicenter Trial Estimating the Persistence of Molecular Remission in Chronic Myeloid Leukemia After Stopping TKI

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

868

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Brno, Czechia, 625 00
        • Fakultní nemocnice
      • Hradec Kralove, Czechia, 50005
        • Fakultni nemocnice Hradec Kralove
      • Olomouc, Czechia, 775 20
        • University Hospital Olomouc
      • Plzen, Czechia, 30460
        • University Hospital Plzen
      • Prague, Czechia, 100 34
        • Fakultni nemocnice Kralovske Vinohrady
      • Prague, Czechia, 12820
        • Ustav hematologie a krevni transfuze
  • Denmark
      • Odense, Denmark, 5000
        • Odense University Hospital
  • Finland
      • Helsinki, Finland, 00029 HUCH
        • Helsinki University Central Hospital
  • France
      • Angers, France, 49933
        • CHU d'Angers
      • Bordeaux, France, 33000
        • Institut Bergonié
      • Bordeaux, France, 33076
        • Université Victor Segalen
      • Chesnay cedex, France, 78157
        • Hôpital André Mignot
      • Clermont Ferrand, France, 63003
        • CHU Estaing
      • Lille, France, 59037
        • Hopital Claude Huriez
      • Lyon, France, 69437
        • Hôpital Edouard Herriot
      • Marseille, France, 13273
        • Institut Paoli-Calmettes (IPC)
      • Nantes, France, 44093
        • Centre Hospitalier Universitaire (CHU) de Nantes
      • Nice, France, 06200
        • Hopital de L'Archet
      • Paris Cedex 15, France, 75743
        • Hôpital Necker-Enfants Malades
      • Paris cedex 10, France, 75475
        • Hôpital Saint-Louis
      • Poitiers, France, 86021
        • Hopital de la Milétrie, Centre Hospitalier Universitaire (CHU) de Poitiers
      • Rennes, France, 35033
        • Hopital Pontchaillou
      • Toulouse, France, 31059
        • Hopital Purpan
      • Tours, France, 37044
        • CHU de Tours
      • Vandoeuvre-lès-Nancy, France, 54511
        • Hôpital de Brabois
  • Germany
      • Aachen, Germany, 52074
        • Uniklinik RWTH
      • Bonn, Germany, 53105
        • Universitätsklinikum
      • Chemnitz, Germany, 09113
        • Klinikum
      • Jena, Germany, 07747
        • Universitätsklinikum
      • Kempten, Germany, 87439
        • Klinikum Kempten-Oberallgau
      • Mannheim, Germany, 68163
        • Universitätsmedizin Mannheim, Universität Heidelberg
      • Marburg, Germany, 35033
        • Universitätsklinikum Giessen und Marburg GmbH
      • Straubing, Germany, 94315
        • MVZ Klinikum Straubing GmbH
  • Greece
      • Athens, Greece, 11526
        • University of Athens, Society of Hematology
  • Netherlands
      • Amsterdam, Netherlands, 1007 MB
        • VU Academic Medical Center
      • Dordrecht, Netherlands, 3300
        • Albert Schweitzer Hospital
  • Norway
      • Oslo, Norway, 0372
        • Oslo Universitetssykehus HF Rikshospitalet
      • Stavanger, Norway, 4068
        • Stavanger University Hospital
      • Tromsø, Norway, 9038
        • University Hospital of Northern Norway
      • Trondheim, Norway, 7489
        • Norwegian University of Science and Technology
  • Portugal
      • Lisboa, Portugal, 1099-023
        • Instituto Portugues de Oncologia Francisco Gentil
  • Sweden
      • Huddinge, Sweden, 141 86
        • Karoliniska Univ hospital Huddinge
      • Linköping, Sweden, 581 85
        • Univ hospital Linköping
      • Luleå, Sweden, 971 80
        • Sunderby Hospital
      • Lund, Sweden, 221 85
        • Lunds Universitet
      • Stockholm, Sweden, 171 76
        • Karoliniska Univ sjh Solna
      • Sundsvall, Sweden, 851 86
        • Länssj Sundsvall
      • Umeå, Sweden, 901 85
        • Norrlands Univ hospital
      • Uppsala, Sweden, 751 85
        • Uppsala University Hospital
      • Örebro, Sweden, 701 85
        • Univ hospital Örebro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • CML in CP under treatment with TKI in first line or in second line because of toxicity to first line TKI or with TKI in combination
  • Duration of TKI treatment before enrolment at least 3 years
  • At least complete molecular remission MR4
  • Before inclusion confirmation of CMR4 through a EUTOS-CMR laboratory
  • Baseline data and documentation on treatment before study entry available
  • Both sexes but fertile women only if using effective contraceptive
  • Health insurance coverage
  • 18 years or older

Exclusion Criteria:

  • Under 18 years old
  • Hospitalized patients without ability to give informed consent
  • Adults under law protection or without ability to consent
  • Previous or planned allogeneic stem cell transplantation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stop treatment
TKI treatment will be stopped in CML patients with very deep molecular responses for at least one year and at least 3 years TKI treatment
Other: Stopping treatment with TKI
stopping until loss of MMR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
molecular relapse-free survival
Time Frame: 3 years
Evaluation of molecular relapse-free survival after stopping TKI (survival without molecular relapse defined by BCR-ABL1 > 0.1% on the IS at one time point (loss of major molecular response, MMR))
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall and progression-free survival
Time Frame: 3 years
Overall and progression-free survival and the probabilities of a restart of TKI without prior molecular relapse
3 years
Treatment costs
Time Frame: 3 years
Saved treatment costs / country from the time off TKI therapy considering also the more frequent PCR monitoring
3 years
QoL
Time Frame: 3 years
Patient reported QoL and symptom burden over time
3 years
Time to recovery
Time Frame: 3 years
Analysing the time to recovery of CMR4 after loss of MMR
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European LeukemiaNet

Investigators

  • Principal Investigator: Susanne Saussele, Prof. Dr., Universitätsmedizin Mannheim, Universität Heidelberg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 30, 2012

Primary Completion (Actual)

December 3, 2014

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

May 8, 2012

First Submitted That Met QC Criteria

May 9, 2012

First Posted (Estimate)

May 10, 2012

Study Record Updates

Last Update Posted (Actual)

November 5, 2021

Last Update Submitted That Met QC Criteria

October 29, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ELN-001
  • 2011-000440-22 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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