Titre A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Of Navitoclax In Combination With Ruxolitinib Versus Ruxolitinib In Subjects With Myelofibrosis
Protocole ID M16-191 (TRANSFORM-1)
ClinicalTrials.gov ID NCT04472598
Type(s) de cancer NMP : Vaquez , Thrombocythémie essentielle, Métaplasie myéloide
Phase Phase III
Type étude Clinique
Médicament Navitoclax en association avec Ruxolitinib versus Ruxolitinib
      1401 18e Rue, Québec, QC, G1J 1Z4
Ville Québec
Investigateur(trice) principal(e) Dr Robert Delage
Coordonnateur(trice) Marie-Claude Lépine
418-649-0252 poste 63401
Statut Actif en recrutement
Critètes d'éligibilité
  • Documented diagnosis of Primary MyeloFibrosis (MF) or Secondary MF (post polycythemia vera [PPV] - MF or Post Essential Thrombocytopenia [PET] - MF) as defined by World Health Organization (WHO) classification.
  • Must be able to complete the MF Symptom Assessment Form (MFSAF) v4.0 on at least 4 out of 7 days prior to randomization.
    -- Must have at least 2 symptoms with a score >=3 or a total score of >=12, as measured by the MFSAF v4.0.
  • Classified as intermediate-2, or high-Risk MF as defined by the Dynamic International Prognostic Scoring System Plus (DIPSS+).
  • Has splenomegaly defined as spleen palpation measurement >= 5 centimeters (cm) below costal margin or spleen volume greater than or equal to 450 cubic cm as assessed centrally by Magnetic Resonance Imaging (MRI) or Computed Tomography (CT) scan.
  • Ineligible for stem cell transplantation at time of study entry due to age, comorbidities, or unfit for unrelated or unmatched donor transplant.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
Critètes d'exclusion
  • Prior treatment with a Janus Kinase-2 (JAK-2) inhibitor.
  • Prior treatment with a BH3-mimetic compound or bromodomain and extra-terminal motif (BET) inhibitor.
  • Receiving medication that interferes with coagulation or platelet function except for low dose aspirin (up to 100 milligram daily) and low molecular weight heparin (LMWH) within 3 days prior to the first dose of study drug or during the study treatment period.