ESTIMATING THE IMPACT OF STOPPING TKI IN CHRONIC MYELOID LEUKEMIA

MULTICENTER TRIAL ESTIMATING THE PERSISTANCE OF MOLECULAR REMISSION IN CHRONIC MYELOID LEUKAEMIA AFTER STOPPING TKI - EURO-SKI

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-000440-22-SE

Enrollment

700

Registered

2012-02-27

Start date

2012-04-11

Completion date

Unknown

Last updated

2014-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with chronic myeloid leukemia with complete molecular response can stop tyrosine kinase inhibitors under close monitoring MedDRA version: 17.0 Level: LLT Classification code 10009016 Term: Chronic myeloid leukemia in remission System Organ Class: 100000004864

Interventions

Trade Name: Tasigna Product Name: Nilotinib Pharmaceutical Form: Capsule Other descriptive name: NILOTINIB HYDROCHLORIDE MONOHYDRATE Trade Name: Glivec Product Name: Imatinib Pharmaceutical Form: Ta

Eligibility

Sex/Gender

All

Inclusion 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 • Complete molecular remission (CMR4 (= 0.01% on IS) for at least one year; at least three PCR-results with CMR4 within the last year (± 2 months) before study entry • Before inclusion confirmation of CMR through a EUTOS-CMR laboratory • Both sexes but fertile women only if using effective contraceptive • Health insurance coverage • 18 years or older Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 500 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 200

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Secondary Objective: 1- Identification of clinical and biological factors affecting the persistence of complete molecular remission after stopping TKI (e.g. level of CMR, risk score, duration of TKI treatment, type of TKI pretreatment) 2- Evaluation of QoL in patients stopping TKI 3- Evaluation of medico-economic impact of stopping TKI 4- Estimating the number of patients in CMR who would be eligible for stopping TKI therapy by setting up a screening log 5- Time to recovery of CMR4 ;Main Objective: Assessment of the duration of MMR or better after stopping of TKI therapy;Primary end point(s): Evaluation of molecular relapse-free survival after stopping TKI (survival without molecular relapse defined by BCR-ABL1 ratio > 0.1% on the IS at one time point (loss of major molecular response, MMR));Timepoint(s) of evaluation of this end point: After 200 patients with follow-up of at least 6 months	—

Measure

Time frame

Secondary Objective: 1- Identification of clinical and biological factors affecting the persistence of complete molecular remission after stopping TKI (e.g. level of CMR, risk score, duration of TKI treatment, type of TKI pretreatment) 2- Evaluation of QoL in patients stopping TKI 3- Evaluation of medico-economic impact of stopping TKI 4- Estimating the number of patients in CMR who would be eligible for stopping TKI therapy by setting up a screening log 5- Time to recovery of CMR4 ;Main Objective: Assessment of the duration of MMR or better after stopping of TKI therapy;Primary end point(s): Evaluation of molecular relapse-free survival after stopping TKI (survival without molecular relapse defined by BCR-ABL1 ratio > 0.1% on the IS at one time point (loss of major molecular response, MMR));Timepoint(s) of evaluation of this end point: After 200 patients with follow-up of at least 6 months

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Secondary

Measure	Time frame
Secondary end point(s): 1-Identification of clinical and biological factors affecting the persistence of MMR and CMR (MR4) after stopping TKI (level of CMR before treatment discontinuation, predicting factors like risk score, duration, dosage and type of TKI pretreatment) 2-Estimation of OS and PFS 3-Estimation of probabilities of a restart of TKI therapy without prior molecular relapse 4-Patient reported QoL and symptom burden over time 5-Evaluation of medico-economic impact of TKI discontinuation 6-Time to recovery of CMR (MR4) after restart of TKI due to relapse (loss of MMR). ;Timepoint(s) of evaluation of this end point: At interim analysis as described above	—

Measure

Time frame

Secondary end point(s): 1-Identification of clinical and biological factors affecting the persistence of MMR and CMR (MR4) after stopping TKI (level of CMR before treatment discontinuation, predicting factors like risk score, duration, dosage and type of TKI pretreatment) 2-Estimation of OS and PFS 3-Estimation of probabilities of a restart of TKI therapy without prior molecular relapse 4-Patient reported QoL and symptom burden over time 5-Evaluation of medico-economic impact of TKI discontinuation 6-Time to recovery of CMR (MR4) after restart of TKI due to relapse (loss of MMR). ;Timepoint(s) of evaluation of this end point: At interim analysis as described above

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Countries

Austria, Finland, Netherlands, Norway, Portugal, Russian Federation, Spain, Sweden, Switzerland

Contacts

Public ContactIII. Medizinische Klinik

Universitätsmedizin Mannheim

susanne.saussele@medma.uni-heidelberg.de+496213836966

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Mar 3, 2026