Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
868 participants
INTERVENTIONAL
2012-05-30
2019-12-31
Brief Summary
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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
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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
Stopping treatment with TKI
stopping until loss of MMR
Interventions
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Stopping treatment with TKI
stopping until loss of MMR
Eligibility Criteria
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Inclusion Criteria
* 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
* Hospitalized patients without ability to give informed consent
* Adults under law protection or without ability to consent
* Previous or planned allogeneic stem cell transplantation
18 Years
ALL
No
Sponsors
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European LeukemiaNet
NETWORK
Responsible Party
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Principal Investigators
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Susanne Saussele, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Universitätsmedizin Mannheim, Universität Heidelberg
Locations
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Fakultní nemocnice
Brno, , Czechia
Fakultní nemocnice Hradec Králové
Hradec Králové, , Czechia
University Hospital Olomouc
Olomouc, , Czechia
University Hospital Plzen
Pilsen, , Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, , Czechia
Ústav hematologie a krevní transfuze
Prague, , Czechia
Odense University Hospital
Odense, , Denmark
Helsinki University Central Hospital
Helsinki, , Finland
CHU d'Angers
Angers, , France
Institut Bergonié
Bordeaux, , France
Université Victor Segalen
Bordeaux, , France
Hôpital André Mignot
Chesnay, , France
Chu Estaing
Clermont-Ferrand, , France
Hôpital Claude Huriez
Lille, , France
Hôpital Édouard Herriot
Lyon, , France
Institut Paoli-Calmettes (IPC)
Marseille, , France
Centre Hospitalier Universitaire (CHU) de Nantes
Nantes, , France
Hôpital de l'Archet
Nice, , France
Hôpital Saint-Louis
Paris, , France
Hôpital Necker-Enfants Malades
Paris, , France
Hopital de la Milétrie, Centre Hospitalier Universitaire (CHU) de Poitiers
Poitiers, , France
Hôpital Pontchaillou
Rennes, , France
Hôpital Purpan
Toulouse, , France
CHU de Tours
Tours, , France
Hôpital de Brabois
Vandœuvre-lès-Nancy, , France
Uniklinik RWTH
Aachen, , Germany
Universitätsklinikum
Bonn, , Germany
Klinikum
Chemnitz, , Germany
Universitätsklinikum
Jena, , Germany
Klinikum Kempten-Oberallgäu
Kempten, , Germany
Universitätsmedizin Mannheim, Universität Heidelberg
Mannheim, , Germany
Universitätsklinikum Giessen und Marburg GmbH
Marburg, , Germany
MVZ Klinikum Straubing GmbH
Straubing, , Germany
University of Athens, Society of Hematology
Athens, , Greece
VU Academic Medical Center
Amsterdam, , Netherlands
Albert Schweitzer Hospital
Dordrecht, , Netherlands
Oslo universitetssykehus HF Rikshospitalet
Oslo, , Norway
Stavanger University Hospital
Stavanger, , Norway
University Hospital of Northern Norway
Tromsø, , Norway
Norwegian University of Science and Technology
Trondheim, , Norway
Instituto Português de Oncologia Francisco Gentil
Lisbon, , Portugal
Karoliniska Univ hospital Huddinge
Huddinge, , Sweden
Univ hospital Linköping
Linköping, , Sweden
Sunderby hospital
Luleå, , Sweden
Lunds Universitet
Lund, , Sweden
Univ hospital Örebro
Örebro, , Sweden
Karoliniska Univ sjh Solna
Stockholm, , Sweden
Länssj Sundsvall
Sundsvall, , Sweden
Norrlands Univ hospital
Umeå, , Sweden
Uppsala University hospital
Uppsala, , Sweden
Countries
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References
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Richter J, Lubking A, Soderlund S, Lotfi K, Markevarn B, Sjalander A, Stenke L, Deneberg S, Ahlstrand E, Myhr-Eriksson K, Panayiotidis P, Gedde-Dahl T, Zackova D, Mayer J, Olsson-Stromberg U, Mahon FX, Saussele S, Hjorth-Hansen H, Koskenvesa P. Molecular status 36 months after TKI discontinuation in CML is highly predictive for subsequent loss of MMR-final report from AFTER-SKI. Leukemia. 2021 Aug;35(8):2416-2418. doi: 10.1038/s41375-021-01173-w. Epub 2021 Feb 15. No abstract available.
Soderlund S, Persson I, Ilander M, Guilhot J, Hjorth-Hansen H, Koskenvesa P, Richter J, Saussele S, Mustjoki S, Olsson-Stromberg U. Plasma proteomics of biomarkers for inflammation or cancer cannot predict relapse in chronic myeloid leukaemia patients stopping tyrosine kinase inhibitor therapy. Leuk Res. 2020 Mar;90:106310. doi: 10.1016/j.leukres.2020.106310. Epub 2020 Jan 23.
Bouillon AS, Ventura Ferreira MS, Awad SA, Richter J, Hochhaus A, Kunzmann V, Dengler J, Janssen J, Ossenkoppele G, Westerweel PE, Te Boekhorst PAW, Mahon FX, Hjorth-Hansen H, Isfort S, Fioretos T, Hummel S, Schemionek M, Wilop S, Koschmieder S, Saussele S, Mustjoki S, Beier F, Brummendorf TH. Telomere shortening correlates with leukemic stem cell burden at diagnosis of chronic myeloid leukemia. Blood Adv. 2018 Jul 10;2(13):1572-1579. doi: 10.1182/bloodadvances.2018017772.
Schutz C, Inselmann S, Saussele S, Dietz CT, Mu Ller MC, Eigendorff E, Brendel CA, Metzelder SK, Bru Mmendorf TH, Waller C, Dengler J, Goebeler ME, Herbst R, Freunek G, Hanzel S, Illmer T, Wang Y, Lange T, Finkernagel F, Hehlmann R, Huber M, Neubauer A, Hochhaus A, Guilhot J, Xavier Mahon F, Pfirrmann M, Burchert A. Expression of the CTLA-4 ligand CD86 on plasmacytoid dendritic cells (pDC) predicts risk of disease recurrence after treatment discontinuation in CML. Leukemia. 2017 Apr;31(4):829-836. doi: 10.1038/leu.2017.9. Epub 2017 Jan 11.
Saussele S, Richter J, Guilhot J, Gruber FX, Hjorth-Hansen H, Almeida A, Janssen JJWM, Mayer J, Koskenvesa P, Panayiotidis P, Olsson-Stromberg U, Martinez-Lopez J, Rousselot P, Vestergaard H, Ehrencrona H, Kairisto V, Machova Polakova K, Muller MC, Mustjoki S, Berger MG, Fabarius A, Hofmann WK, Hochhaus A, Pfirrmann M, Mahon FX; EURO-SKI investigators. Discontinuation of tyrosine kinase inhibitor therapy in chronic myeloid leukaemia (EURO-SKI): a prespecified interim analysis of a prospective, multicentre, non-randomised, trial. Lancet Oncol. 2018 Jun;19(6):747-757. doi: 10.1016/S1470-2045(18)30192-X. Epub 2018 May 4.
Ilander M, Olsson-Stromberg U, Schlums H, Guilhot J, Bruck O, Lahteenmaki H, Kasanen T, Koskenvesa P, Soderlund S, Hoglund M, Markevarn B, Sjalander A, Lotfi K, Dreimane A, Lubking A, Holm E, Bjoreman M, Lehmann S, Stenke L, Ohm L, Gedde-Dahl T, Majeed W, Ehrencrona H, Koskela S, Saussele S, Mahon FX, Porkka K, Hjorth-Hansen H, Bryceson YT, Richter J, Mustjoki S. Increased proportion of mature NK cells is associated with successful imatinib discontinuation in chronic myeloid leukemia. Leukemia. 2017 May;31(5):1108-1116. doi: 10.1038/leu.2016.360. Epub 2016 Nov 28.
Rinaldetti S, Pfirrmann M, Manz K, Guilhot J, Dietz C, Panagiotidis P, Spiess B, Seifarth W, Fabarius A, Muller M, Pagoni M, Dimou M, Dengler J, Waller CF, Brummendorf TH, Herbst R, Burchert A, Janbetaen C, Goebeler ME, Jost PJ, Hanzel S, Schafhausen P, Prange-Krex G, Illmer T, Janzen V, Klausmann M, Eckert R, Buschel G, Kiani A, Hofmann WK, Mahon FX, Saussele S. Effect of ABCG2, OCT1, and ABCB1 (MDR1) Gene Expression on Treatment-Free Remission in a EURO-SKI Subtrial. Clin Lymphoma Myeloma Leuk. 2018 Apr;18(4):266-271. doi: 10.1016/j.clml.2018.02.004. Epub 2018 Feb 8.
Other Identifiers
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2011-000440-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ELN-001
Identifier Type: -
Identifier Source: org_study_id