Ignite Creation Date:
2024-05-06 @ 12:30 AM
Last Modification Date:
2024-10-26 @ 10:51 AM
Study NCT ID:
NCT01596114
Status:
COMPLETED
Last Update Posted:
2021-11-05
First Post:
2012-05-08
Brief Title:
European Stop Tyrosine Kinase Inhibitor Study
Sponsor:
European LeukemiaNet
Organization:
European LeukemiaNet
Study Overview
Official Title:
Multicenter Trial Estimating the Persistence of Molecular Remission in Chronic Myeloid Leukemia After Stopping TKI
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EURO-SKI
Brief Summary:
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 eg 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 n500
Secondary goals include
Identification of clinical and biological factors affecting the persistence of complete molecular remission after stopping TKI eg 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 n500
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2011-000440-22 | EUDRACT_NUMBER | None | None |