Ignite Creation Date:
2024-05-06 @ 9:09 AM
Last Modification Date:
2024-10-26 @ 12:10 PM
Study NCT ID:
NCT02917720
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-12-11
First Post:
2016-03-02
Brief Title:
2nd or 3rd TKI-stop After 2 Years Nilotinib Pre-treatment in CML-patients
Sponsor:
European LeukemiaNet
Organization:
European LeukemiaNet
Study Overview
Official Title:
Multicenter Prospective Trial After 1st or 2nd Unsuccessful Treatment Discontinuation in Chronic Myeloid Leukemia CML Estimating the Efficacy of Nilotinib in Inducing the Persistence of Molecular Remission After Stopping TKI a 2nd or 3rd Time
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-12
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:
NAUT
Brief Summary:
The main goal of the study is the assessment of duration of major molecular response MMR or better at 12 and 36 months after stopping tyrosine kinase inhibitors TKI therapy a second or third time in patients with at least three years prior TKI treatment comprising at least two years of nilotinib treatment within this trial and maintained stable MR4 BCR-ABL ratio 001 on international Scale IS for at least one year and MR45 BCR-ABL ratio 00032 on IS for at least 6 months
who failed a first stop in the EURO-SKI study standardized criteria
who failed a first or second stop outside the EURO-SKI study but would have had fulfilled same eligible criteria and were stopped according to EURO-SKI rules
who failed a first or second stop outside the EURO-SKI study without fulfilling EURO-SKI rules
who failed a first stop in the EURO-SKI study standardized criteria
who failed a first or second stop outside the EURO-SKI study but would have had fulfilled same eligible criteria and were stopped according to EURO-SKI rules
who failed a first or second stop outside the EURO-SKI study without fulfilling EURO-SKI rules
Detailed Description:
The proposal is to re-treat patients with a minimum of two years with nilotinib 2x300 mgd resulting in total of at least three years TKI treatment who show recurrent disease after unsuccessful first or second stop after TKI treatment in or outside the EURO-SKI study
If MR4 or better is re-achieved and maintained for at least one year and MR45 or better is re-achieved and maintained for at least 6 months patients will be eligible for a second stop attempt within this study For MR4 three consecutive PCRs with MR4 or deeper should be measured within one year and for MR45 two PCRs during 6 months should demonstrate a MR45
Patients who exhibited hematological relapse after the first stop attempt will not be eligible for a second stop attempt within this study
After inclusion 3 monthly monitoring will be performed under nilotinib treatment within the trial Patients fulfilling the criteria mentioned above will then enter the screening phase
After verification of MR45 TKI treatment will be stopped and patients followed in the same manner as described in EURO-SKI monthly PCRs for 6 months 6-weekly PCRs 7-12 months after stopping thereafter 3-monthly If MMR is lost BCR-ABL 01 IS TKI treatment will once again be restarted here the same TKI nilotinib is recommended
It is assumed that after failure of first or second stop a switch to treatment with 2GTKI may increase the chance of stopping a second or third time Legros et al Blood 2012 Rea et al Blood 2014 It is expected that the rate of a successful second or third stop at 12 and 36 months is more than 25
If MR4 or better is re-achieved and maintained for at least one year and MR45 or better is re-achieved and maintained for at least 6 months patients will be eligible for a second stop attempt within this study For MR4 three consecutive PCRs with MR4 or deeper should be measured within one year and for MR45 two PCRs during 6 months should demonstrate a MR45
Patients who exhibited hematological relapse after the first stop attempt will not be eligible for a second stop attempt within this study
After inclusion 3 monthly monitoring will be performed under nilotinib treatment within the trial Patients fulfilling the criteria mentioned above will then enter the screening phase
After verification of MR45 TKI treatment will be stopped and patients followed in the same manner as described in EURO-SKI monthly PCRs for 6 months 6-weekly PCRs 7-12 months after stopping thereafter 3-monthly If MMR is lost BCR-ABL 01 IS TKI treatment will once again be restarted here the same TKI nilotinib is recommended
It is assumed that after failure of first or second stop a switch to treatment with 2GTKI may increase the chance of stopping a second or third time Legros et al Blood 2012 Rea et al Blood 2014 It is expected that the rate of a successful second or third stop at 12 and 36 months is more than 25
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 |
|---|---|---|---|
| 2015-004998-33 | EUDRACT_NUMBER | None | None |