Ignite Creation Date:
2024-05-06 @ 6:41 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05753384
Status:
RECRUITING
Last Update Posted:
2024-03-20
First Post:
2023-02-09
Brief Title:
Discontinuation of TyrosIne Kinase Inhibitors TKI in Chronic Myeloid Leukemia CML and Impact on the Immune System
Sponsor:
Poitiers University Hospital
Organization:
Poitiers University Hospital
Study Overview
Official Title:
Discontinuation of TyrosIne Kinase Inhibitors ITK in Chronic Myeloid Leukemia LMC and Impact on the Immune System a Randomized Comparative Study of Two Therapeutic Strategies
Status:
RECRUITING
Status Verified Date:
2024-07
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:
None
Brief Summary:
Tyrosine kinase inhibitors TKI have revolutionized the management and prognosis of chronic myeloid leukemia CML Daily treatment with TKI which is necessary due to lack of cure is frequently associated with moderate chronic and sometimes severe adverse effects The ability to permanently stop treatment with TKI has thus become a major goal in CML to prevent the occurrence of adverse events improve quality of life and reduce the general cost of the treatment we talk about Treatment Free Remission TFR It now remains to be demonstrated in a comparative prospective study that a strategy of de-escalation of the TKI treatment dose before treatment discontinuation optimizes TFR results At the same time it is possible to reduce adverse reactions and improve the quality of life of patients In this context the investigator propose to conduct a randomized clinical trial including CML patients allowing to compare the results of TFR at 24 months between a sudden stop of treatment after a maintenance phase of dosage for 12 months and a de-escalation arm of dose dosage reduced by 50 for 12 months before stopping A secondary immunological translational objective of this project will be to compare the quantitative and qualitative evolution of innate CD8 T cells between the 2 arms abrupt cessation of ITK treatment versus progressive withdrawal and look for a predictive innate CD8 T cells blood signature at the time of stopping treatment of a successful TFR in both arms
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None