Evaluation of a Cardiovascular Active Prevention in Chronic Myeloid Leukemia on the Cardiovascular Morbi-mortality (PALERMO)
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|ClinicalTrials.gov Identifier: NCT03746054|
Recruitment Status : Not yet recruiting
First Posted : November 19, 2018
Last Update Posted : November 21, 2018
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 benefit/risk ratio, 10% of patients treated with nilotinib 300 mg twice daily and 15.9% 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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Myeloid Leukemia (CML)||Combination Product: Optimal medical treatment Combination Product: usual clinical practice||Phase 3|
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||340 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Estimated Study Start Date :||March 2019|
|Estimated Primary Completion Date :||March 2021|
|Estimated Study Completion Date :||March 2023|
Experimental: active prevention
optimal medical treatment
Combination Product: Optimal medical treatment
Life style modifications, Monitoring of the risk factors and Optimal medical treatment Lipid-lowering treatment, anti-platelet treatment and ACEi or AT2 antagonists treatment for a total duration of 24 months
Sham Comparator: usual clinical practice
usual clinical practice in each center
Combination Product: usual clinical practice
usual clinical practice in each center
- Improvementof the Event Free Survival (EFS) rate in CML patients with an active and systematic prevention for cardiovascular risk. [ Time Frame: 24 months ]The Event Free Survival (EFS) is based on the analysis of the time to an event occurrence.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03746054
|Contact: HENNI SAMIR, MD, PhD||33(0)firstname.lastname@example.org|
|Contact: MARECHAL-GIRAULT STEPHANIE, MSc||33(0)241356208||StMarechal@chu-angers.fr|
|Principal Investigator:||HENNI SAMIR, MD, PhD||Angers Teaching Hospital|