European Stop Tyrosine Kinase Inhibitor Study (EURO-SKI)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01596114 |
Recruitment Status :
Completed
First Posted : May 10, 2012
Last Update Posted : November 5, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Myeloid Leukemia | Other: Stopping treatment with TKI | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 868 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Multicenter Trial Estimating the Persistence of Molecular Remission in Chronic Myeloid Leukemia After Stopping TKI |
Actual Study Start Date : | May 30, 2012 |
Actual Primary Completion Date : | December 3, 2014 |
Actual Study Completion Date : | December 31, 2019 |
Arm | Intervention/treatment |
---|---|
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 |
- 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))
- 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
- Treatment costs [ Time Frame: 3 years ]Saved treatment costs / country from the time off TKI therapy considering also the more frequent PCR monitoring
- QoL [ Time Frame: 3 years ]Patient reported QoL and symptom burden over time
- Time to recovery [ Time Frame: 3 years ]Analysing the time to recovery of CMR4 after loss of MMR
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01596114
Principal Investigator: | Susanne Saussele, Prof. Dr. | Universitätsmedizin Mannheim, Universität Heidelberg |
Other Publications:
Responsible Party: | European LeukemiaNet |
ClinicalTrials.gov Identifier: | NCT01596114 |
Other Study ID Numbers: |
ELN-001 2011-000440-22 ( EudraCT Number ) |
First Posted: | May 10, 2012 Key Record Dates |
Last Update Posted: | November 5, 2021 |
Last Verified: | October 2021 |
TKI CML Stopping chronic phase in remission |
Leukemia Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Neoplasms by Histologic Type Neoplasms Hematologic Diseases Myeloproliferative Disorders Bone Marrow Diseases |
Chronic Disease Disease Attributes Pathologic Processes Tin Fluorides Cariostatic Agents Protective Agents Physiological Effects of Drugs |