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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
868

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Bergonie
      • Bordeaux, France, 33076
        • Université Victor Segalen
      • Chesnay cedex, France, 78157
        • Hopital Andre 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
        • Hôpital de l'Archet
      • Paris Cedex 15, France, 75743
        • Hôpital Necker-Enfants Malades
      • Paris cedex 10, France, 75475
        • Hopital 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-Oberallgäu
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
European LeukemiaNet

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 30, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 3, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 8, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 9, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 10, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 5, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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