Groupe d'Etude en Oncologie du Quebec

Titre	A Phase 3, Randomized, Double-blind, Active-Control Study of CPI-0610 and Ruxolitinib vs. Placebo and Ruxolitinib in JAKi Treatment Naive MF Patients
Protocole ID	MANIFEST-2
ClinicalTrials.gov ID	NCT04603495
Type(s) de cancer	NMP : Vaquez , Thrombocythémie essentielle, Métaplasie myéloide
Phase	Phase III
Type étude	Clinique
Médicament	CPI-0610 et Ruxolitinib versus placebo et Ruxolitinib
Institution	CIUSSS DE L'EST-DE-L'ILE-DE-MONTREAL PAV. MAISONNEUVE/PAV. MARCEL-LAMOUREUX 5415 boul. de l'Assomption, Montréal, QC, H1T2M4
Ville	Montréal
Investigateur(trice) principal(e)	Dre Natasha Szuber
Coordonnateur(trice)	Michaël Harnois 514-252-3400 poste 6288
Statut	Fermé
Critètes d'éligibilité	Aged ≥ 18 years Confirmed diagnosis of myelofibrosis (primary, post-polycythemia vera, or post essential thrombocythemia) Adequate hematologic, renal, and hepatic function Have at least 2 symptoms with an average score ≥ 3 or an average total score of ≥ 10 over the 7-day period prior to randomization using the MFSAF v4.0 Prognostic risk-factor score of Intermediate-1 or higher per Dynamic International Prognostic Scoring System (DIPSS) scoring system Spleen volume of ≥ 450 cm^3 Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Critètes d'exclusion	Splenectomy or splenic irradiation in the previous 6 months Chronic or active conditions and/or concomitant medication use that would prohibit treatment Had prior treatment with any JAKi or BET inhibitor for treatment of a myeloproliferative neoplasm

Groupe d'étude en oncologie du Québec