Myelofibrosis
Conditions
Interventions
Experimental: Arm A: Navitoclax + Ruxolitinib
- Participants will receive Navitoclax in combination with Ruxolitinib
Active Comparator: Arm B: Placebo for Navitoclax + Ruxolitinib
- Participants will
Sponsors
Tsutsui Atsuko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Documented diagnosis of Primary MyeloFibrosis (MF) as defined by World Health Organization (WHO) classification or Secondary MF (post polycythemia vera [PPV] - MF or Post Essential Thrombocytopenia [PET] - MF) . - 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 and other criteria per National Comprehensive Cancer Network guidelines. - Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
Exclusion criteria
Exclusion criteria: - 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 or stem cell transplant. - Receiving medication that interferes with coagulation or platelet function within 3 days prior to the first dose of study drug or during the study treatment period except for low dose aspirin (up to 100 milligram daily) and low molecular weight heparin (LMWH).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants who achieve Spleen Volume Reduction of at least 35% at Week 24 (SVR35W24) | — |
Countries
Australia, Austria, Belgium, Bulgaria, Canada, Croatia, France, Germany, Greece, Israel, Italy, Japan, Korea, Netherlands, New Zealand, Russia, Serbia, South Africa, Spain, Sweden, Taiwan, Turkey, Ukraine, United Kingdom, United States
Contacts
Public ContactContact for Patients and HCP
AbbVie. G.K.
Outcome results
None listed