Ignite Creation Date:
2024-05-06 @ 12:22 PM
Last Modification Date:
2024-10-26 @ 12:58 PM
Study NCT ID:
NCT03746054
Status:
UNKNOWN
Last Update Posted:
2022-07-28
First Post:
2018-11-15
Brief Title:
Evaluation of a Cardiovascular Active Prevention in Chronic Myeloid Leukemia on the Cardiovascular Morbi-mortality
Sponsor:
University Hospital Angers
Organization:
University Hospital Angers
Study Overview
Official Title:
Phase III Study Randomized Multicenter Evaluating the Efficacy of a Cardiovascular Active Prevention Vs Usual Clinical Practice on the Morbi-mortality Decrease in Chronic Myeloid Leukemia Patients Treated With Tyrosine Kinase Inhibitor
Status:
UNKNOWN
Status Verified Date:
2022-07
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
PALERMO
Brief Summary:
According to the French National Cancer Institute 35 000 new hematologic cancers are observed in France representing 10 of the new cancers Chronic Myeloid Leukemia CML is a cancer involving the bone marrow and blood cells the median age at diagnosis is 53 years in the Western world The prognosis is worse than many other cancers with net survival at 5 years of 26
Since the approval of imatinib additional tyrosine kinase inhibitors TKIs have been approved by the European Medicine Agency including the second-generation TKIs nilotinib dasatinib and bosutinib and the third-generation TKI ponatinib Despite their effect on the evolution of CML there is increasing of cardiovascular toxicities which can impact patient morbidity and mortality The majority of the cardiovascular toxicities are associated with the second- and third-generation TKIs Nilotinib and ponatinib cardiovascular toxicity including arterial and venous thromboembolism has decrease the benefitrisk ratio 10 of patients treated with nilotinib 300 mg twice daily and 159 treated with 400 mg twice daily experienced a vascular complication including myocardial infarction ischemic heart disease cerebrovascular accidents or peripheral arterial disease Regarding ponatinib serious arterial occlusive adverse reactions occurred in 19 of patients
In an attempt to reduce major adverse cardiovascular events MACE due to nilotinib and ponatinib currently then approach is driven by usual clinical practice without any robust published evidence The investigators aim to perform a national clinical trial multicenter prospective randomized with two parallel comparative arms experimental group with cardiovascular active prevention vs non active cardiovascular active prevention based on usual clinical practice Our hypothesis is that active prevention of cardiovascular toxicities with optimal medical treatment improves the benefit-risk ratio in CML patients The primary objective is Event Free Survival EFS at month 24
Since the approval of imatinib additional tyrosine kinase inhibitors TKIs have been approved by the European Medicine Agency including the second-generation TKIs nilotinib dasatinib and bosutinib and the third-generation TKI ponatinib Despite their effect on the evolution of CML there is increasing of cardiovascular toxicities which can impact patient morbidity and mortality The majority of the cardiovascular toxicities are associated with the second- and third-generation TKIs Nilotinib and ponatinib cardiovascular toxicity including arterial and venous thromboembolism has decrease the benefitrisk ratio 10 of patients treated with nilotinib 300 mg twice daily and 159 treated with 400 mg twice daily experienced a vascular complication including myocardial infarction ischemic heart disease cerebrovascular accidents or peripheral arterial disease Regarding ponatinib serious arterial occlusive adverse reactions occurred in 19 of patients
In an attempt to reduce major adverse cardiovascular events MACE due to nilotinib and ponatinib currently then approach is driven by usual clinical practice without any robust published evidence The investigators aim to perform a national clinical trial multicenter prospective randomized with two parallel comparative arms experimental group with cardiovascular active prevention vs non active cardiovascular active prevention based on usual clinical practice Our hypothesis is that active prevention of cardiovascular toxicities with optimal medical treatment improves the benefit-risk ratio in CML patients The primary objective is Event Free Survival EFS at month 24
Detailed Description:
At admission eligible patients are proposed to participate Written consent is signed after complete oral and written explanation of the protocol is signed
The efficacity of the cardiovascular active prevention will be studied by comparing the rate of Event free Survival between patients in the Experimental Arm Versus usual Clinical practices
The duration of participation for a subject is equal to 2 years
The efficacity of the cardiovascular active prevention will be studied by comparing the rate of Event free Survival between patients in the Experimental Arm Versus usual Clinical practices
The duration of participation for a subject is equal to 2 years
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