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History of Changes for Study: NCT01596114
European Stop Tyrosine Kinase Inhibitor Study (EURO-SKI)
Latest version (submitted October 29, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 May 9, 2012 None (earliest Version on record)
2 March 11, 2014 Recruitment Status, Study Status, Contacts/Locations, Arms and Interventions and Study Description
3 March 12, 2014 Contacts/Locations and Study Status
4 March 13, 2014 Contacts/Locations and Study Status
5 March 14, 2014 Contacts/Locations and Study Status
6 March 17, 2014 Contacts/Locations and Study Status
7 July 21, 2015 Recruitment Status, Study Status, Contacts/Locations and Study Design
8 September 12, 2016 Study Status
9 August 23, 2017 Study Status and Contacts/Locations
10 May 14, 2020 Study Status, References, Contacts/Locations, Arms and Interventions and Study Design
11 October 29, 2021 Recruitment Status, Study Status and References
Comparison Format:
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Study NCT01596114
Submitted Date:  May 9, 2012 (v1)
Open or close this module Study Identification
Unique Protocol ID: ELN-001
Brief Title: European Stop Tyrosine Kinase Inhibitor Study (EURO-SKI)
Official Title: Multicenter Trial Estimating the Persistence of Molecular Remission in Chronic Myeloid Leukemia After Stopping TKI
Secondary IDs: 2011-000440-22 [EudraCT Number]
Open or close this module Study Status
Record Verification: May 2012
Overall Status: Not yet recruiting
Study Start: June 2012
Primary Completion: June 2015 [Anticipated]
Study Completion: June 2017 [Anticipated]
First Submitted: May 8, 2012
First Submitted that
Met QC Criteria:		 May 9, 2012
First Posted: May 10, 2012 [Estimate]
Last Update Submitted that
Met QC Criteria:		 May 9, 2012
Last Update Posted: May 10, 2012 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: European LeukemiaNet
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief 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 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: n=500
Detailed Description:
Open or close this module Conditions
Conditions: Chronic Myeloid Leukemia
Keywords: TKI
CML
Stopping
chronic phase
in remission
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Single Group Assignment
Number of Arms:
Masking: None (Open Label)
Allocation: N/A
Enrollment: 500 [Anticipated]
Open or close this module Arms and Interventions
Intervention Details:
Stopping treatment with TKI
stopping until loss of MMR
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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))
Secondary Outcome Measures:
1. 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
2. Treatment costs
[ Time Frame: 3 years ]

Saved treatment costs / country from the time off TKI therapy considering also the more frequent PCR monitoring
3. QoL
[ Time Frame: 3 years ]

Patient reported QoL and symptom burden over time
4. Time to recovery
[ Time Frame: 3 years ]

Analysing the time to recovery of CMR4 after loss of MMR
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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
Open or close this module Contacts/Locations
Central Contact Person: Susanne Saussele, Dr.
Telephone: +496213836966
Email: susanne.saussele@medma.uni-heidelberg.de
Central Contact Backup: Francois X Mahon, Prof
Telephone: 33 (0)5 57 57 10 10
Email: Francois-Xavier.Mahon@u-bordeaux2.fr
Study Officials: Susanne Saussele, Dr.
Principal Investigator
Universitätsmedizin Mannheim, Universität Heidelberg
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:
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