TITRE |
Étude de phase II multicentrique, ouverte et à répartition aléatoire, visant à évaluer l’asciminib oral en association avec l’imatinib, comparativement à la poursuite de l’imatinib et au passage à un traitement par le nilotinib chez des patients atteints de leucémie myéloïde chronique en phase chronique (LMC-PC), qui ont déjà reçu l’imatinib mais qui n’ont pas obtenu une réponse moléculaire profonde |
PROTOCOLE ID |
CABL001E2201 |
CLINICAL TRIAL.gov ID |
NCT03578367 |
TYPE(S) DE CANCER |
Leucémie myéloïde chronique (LMC) |
PHASE |
Phase II |
TYPE D'ÉTUDE |
Traitement |
INSTITUTION |
CIUSSS DE L'EST-DE-L'ILE-DE-MONTREAL
5415 boul. de l'Assomption
(514) 252-3400
|
VILLE |
Montréal
|
INVESTIGATEUR(RICE) PRINCIPAL(E) |
Lambert Busque
|
COORDONATEUR(RICE) |
Michaël Harnois mharnois.hmr@ssss.gouv.qc.ca 514-252-3400 poste 6288
|
STATUT |
Fermé
|
CRITÈRES D'ÉLIGIBILITÉ |
(EN)
|
CRITÈRES D'EXCLUSION |
(EN)
- Treatment failure according to European Leukemia Network (ELN) criteria 2013 during imatinib treatment.
- Known second chronic phase of CML after previous progression to Accelerated Phase (AP)/Blast Crisis (BC).
- Previous treatment with any tyrosine kinese inhibitors (TKIs) other than imatinib.
-
History or current diagnosis of ECG abnormalities indicating significant risk or safety for subjects participating in the study such as:
- History of myocardial infarction, angina pectoris, coronary artery bypass graft within 6 months prior to randomization
- Concomitant clinically significant arrhythmias
- Resting QTcF ≥ 450 msec (male) or ≥ 460 msec (female) prior to randomization
-
Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome, or any of the following:
- Risk factors for Torsades de Pointes
- Concomitant medications with a "known" risk of Torsades de Pointes
- inability to determine the QTcF interval
- Severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol (e.g. uncontrolled diabetes, active or uncontrolled infection, uncontrolled clinically significant hyperlipidemia and high serum amylase)
- History of acute pancreatitis within 1 year prior to randomization or past medical history of chronic pancreatitis.
- History of other active malignancy within 3 years prior to randomization with the exception of basal cell skin cancer, indolent prostate cancer and carcinoma in situ treated curatively.
- Other protocol defined inclusion/exclusion may apply.
|