Clinical Trials Logo
  1. Home
  2. Chronic Myeloid Leukemia (CML)
  3. NCT03746054

Evaluation of a Cardiovascular Active Prevention in Chronic Myeloid Leukemia on the Cardiovascular Morbi-mortality — PALERMO  

Chronic Myeloid Leukemia (CML) Clinical Trial

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

Clinical Trial 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 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.

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03746054
Study type Interventional
Source University Hospital, Angers
Contact
Status Active, not recruiting
Phase Phase 3
Start date December 20, 2019
Completion date March 2024
View Details
See also
  Status Clinical Trial Phase
Terminated NCT01066468 - Glivec/Gleevec Pediatric (Age 1 to Less Than 4) PK Study in CML, Ph+ ALL Patients and Other Glivec/Gleevec® Indicated Hematological Disorders. Phase 1
Completed NCT00428909 - Effect of Imatinib Mesylate and the Pharmacokinetics of Acetaminophen/Paracetamol in Patients With Newly Diagnosed, Previously Untreated Chronic Myeloid Leukemia in Chronic Phase (CML-CP) Phase 1
Completed NCT04126707 - The Absorption, Metabolism and Excretion of [14C] HQP1351 in Humans Phase 1
Active, not recruiting NCT02061800 - CD34+ (Malignant) Stem Cell Selection for Patients Receiving Allogenic Stem Cell Transplant Phase 1/Phase 2
Completed NCT00488592 - Peptide Vaccinations to Treat Patients With Low-Risk Myeloid Cancers Phase 2
Terminated NCT03615105 - Donor Stem Cell Transplantation Using α/β+ T-lymphocyte Depleted Grafts From HLA Mismatched Donors Phase 2
Recruiting NCT02790515 - Provision of TCRγδ T Cells and Memory T Cells Plus Selected Use of Blinatumomab in Naïve T-cell Depleted Haploidentical Donor Hematopoietic Cell Transplantation for Hematologic Malignancies Relapsed or Refractory Despite Prior Transplantation Phase 2
Active, not recruiting NCT03849651 - TCRαβ-depleted Progenitor Cell Graft With Additional Memory T-cell DLI, Plus Selected Use of Blinatumomab, in Naive T-cell Depleted Haploidentical Donor Hematopoietc Cell Transplantation for Hematologic Malignancies Phase 2
Completed NCT02363868 - Healthcare Costs Among Patients With CML Receiving Dasatinib or Nilotinib in a Commercial and Medicare Population N/A
Withdrawn NCT01605981 - Trial Evaluating Nilotinib as Treatment for Newly Diagnosed CML Patients in Accelerated Phase. Phase 4
Completed NCT00433745 - Wilm's Tumor 1 (WT1) Peptide Vaccine for High Risk Hematologic Malignancy Phase 2
Not yet recruiting NCT04709731 - Cardiovascular Assessment of Ponatinib as Third Line Treatment in Chronic Phase Chronic Myeloid Leukemia Phase 2
Recruiting NCT03481868 - EPIgenetics and in Vivo Resistance of Chronic Myeloid Leukemia Stem Cells to Tyrosine Kinase Inhibitors N/A
Recruiting NCT02889003 - Second STOP After Pioglitazone Priming in CML Patients Phase 2
Completed NCT02733445 - Metabolic Outcomes in Patients Receiving Tyrosine Kinase Inhibitor (TKI) Therapy With Dasatinib or Nilotinib N/A
Completed NCT01667133 - A Study of Ponatinib in Japanese Participants With Chronic Myeloid Leukemia (CML) and Ph+ Acute Lymphoblastic Leukemia (ALL) Phase 1/Phase 2
Completed NCT00720785 - Natural Killer Cells and Bortezomib to Treat Cancer Phase 1
Recruiting NCT05963061 - Chronic Myeloid Leukemia (CML) Real-Life Database
Approved for marketing NCT01592136 - Expanded Access Program of Ponatinib N/A