Neoplasms

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Leukemia

Leukemia, Myeloid

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Neoplasms by Histologic Type

Hematologic Diseases

Myeloproliferative Disorders

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Myeloid Leukemia

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Chronic Myeloid Leukemia

Chronic Myeloproliferative Disorders

All Drugs and Chemicals

Amino Acids

Tin Fluorides

Tyrosine Kinase Inhibitors

Fluorides

Protective Agents

Tyrosine

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

Susanne Saussele, Prof. Dr.

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

European Stop Tyrosine Kinase Inhibitor Study

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

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))

Overall and progression-free survival and the probabilities of a restart of TKI without prior molecular relapse

Saved treatment costs / country from the time off TKI therapy considering also the more frequent PCR monitoring

Patient reported QoL and symptom burden over time

Analysing the time to recovery of CMR4 after loss of MMR

European LeukemiaNet

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
European Stop Tyrosine Kinase Inhibitor Study	NCT01596114	Chronic Myeloid...	Stopping treatm...	18 Years -	European LeukemiaNet
European Stop Tyrosine Kinase Inhibitor Study	NCT01596114	Chronic Myeloid...	Stopping treatm...	18 Years -	European LeukemiaNet

Spots Global Cancer Trial Database for stopping

Every month we try and update this database with for stopping cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for stopping

Every month we try and update this database with for stopping cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for stopping cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.