European Stop Tyrosine Kinase Inhibitor Study (EURO-SKI)
This study is not yet open for participant recruitment.
Verified May 2012 by European LeukemiaNet
Sponsor:
European LeukemiaNet
Information provided by (Responsible Party):
European LeukemiaNet
ClinicalTrials.gov Identifier:
NCT01596114
First received: May 8, 2012
Last updated: May 9, 2012
Last verified: May 2012
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Myeloid Leukemia |
Other: Stopping treatment with TKI |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Multicenter Trial Estimating the Persistence of Molecular Remission in Chronic Myeloid Leukemia After Stopping TKI |
Resource links provided by NLM:
Further study details as provided by European LeukemiaNet:
Primary Outcome Measures:
- molecular relapse-free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]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:
- Overall and progression-free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]Overall and progression-free survival and the probabilities of a restart of TKI without prior molecular relapse
- Treatment costs [ Time Frame: 3 years ] [ Designated as safety issue: No ]Saved treatment costs / country from the time off TKI therapy considering also the more frequent PCR monitoring
- QoL [ Time Frame: 3 years ] [ Designated as safety issue: No ]Patient reported QoL and symptom burden over time
- Time to recovery [ Time Frame: 3 years ] [ Designated as safety issue: No ]Analysing the time to recovery of CMR4 after loss of MMR
| Estimated Enrollment: | 500 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | June 2017 |
| Estimated Primary Completion Date: | June 2015 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Other: Stopping treatment with TKI
stopping until loss of MMR
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01596114
Contacts
| Contact: Susanne Saussele, Dr. | +496213836966 | susanne.saussele@medma.uni-heidelberg.de |
| Contact: Francois X Mahon, Prof | 33 (0)5 57 57 10 10 | Francois-Xavier.Mahon@u-bordeaux2.fr |
Sponsors and Collaborators
European LeukemiaNet
Investigators
| Principal Investigator: | Susanne Saussele, Dr. | Universitätsmedizin Mannheim, Universität Heidelberg |
More Information
No publications provided
| Responsible Party: | European LeukemiaNet |
| ClinicalTrials.gov Identifier: | NCT01596114 History of Changes |
| Other Study ID Numbers: | ELN-001, 2011-000440-22 |
| Study First Received: | May 8, 2012 |
| Last Updated: | May 9, 2012 |
| Health Authority: | Sweden: Medical Products Agency |
Keywords provided by European LeukemiaNet:
|
TKI CML Stopping chronic phase in remission |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Neoplasms by Histologic Type Neoplasms Myeloproliferative Disorders Bone Marrow Diseases |
Hematologic Diseases Tin Fluorides Cariostatic Agents Protective Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 17, 2013