Ignite Creation Date:
2024-05-06 @ 3:49 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04771507
Status:
RECRUITING
Last Update Posted:
2021-02-25
First Post:
2021-02-19
Brief Title:
A Pilot Study on Intermittent Ibrutinib in Patients With Advanced-phase Chronic Lymphocytic Leukemia CLL
Sponsor:
Jeanette Lundin
Organization:
Karolinska University Hospital
Study Overview
Official Title:
A Pilot Study on Intermittent and Repeated Dosing of Ibrutinib in the Treatment of Patients With Advanced-phase Chronic Lymphocytic Leukemia CLL
Status:
RECRUITING
Status Verified Date:
2021-02
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:
IbruOnOff
Brief Summary:
Ibrutinib an inhibitor of Brutons tyrosine kinase BTK is approved in CLL as continuous daily administration of 420 mg orally until progression Ibrutinib drug costs in health care are rapidly increasing and are difficult to predict as long-term follow up analyses have shown that many patients remain on therapy for several years in some cases even many years It has been observed that patients who stop ibrutinib due to side effects may often remain with continued CLL disease control ie in stable partial remission even when off ibrutinib therapy There are also emerging data on mutations within BTK with loss of efficacy of ibrutinib during long-term continuous administration These observations raise the question whether alternative dosing strategies may be feasible This pilot study will explore intermittent and repeated dosing of ibrutinib until alternative therapy is required due to resistance or intolerance to ibrutinib An ON-OFF dosing strategy will be applied where advanced-phase CLL patients who have received at least 6 months of ibrutinib and who have achieved a stable PR will stop ibrutinib and be followed off therapy until clinical progression at which ibrutinib will be re-instituted Such ON-OFF ibrutinib cycles may be repeated until non-tolerability or resistance or need of continuous dosing of ibrutinib ie early progression when off the drug If successful the study will indicate a way forward towards reducing ibrutinib drug costs in health care without affecting long-term disease control possibly also with fewer ibrutinib-related side effects due to a lower cumulative dose of ibrutinib Long-term effects on potential mutations within BTK and its downstream signaling molecules will also be analysed
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