Summary
Myelofibrosis is a type of bone marrow cancer that usually develops slowly and disrupts
body's normal production of blood cells. It causes bone marrow scarring, leading to severe
anemia that can cause weakness and fatigue. It can also cause a low number of blood-clotting
cells called platelets, which increases risk of bleeding. Myelofibrosis often causes an
enlarged spleen. The purpose of this study is to see if a combination of navitoclax and
ruxolitinib is more effective and safe in assessment of change in spleen volume when compared
to ruxolitinib in participants with myelofibrosis.
Navitoclax is an investigational drug for the treatment of myelofibrosis. Participants in
this study are divided into two groups, called treatment arms. Each group receives a
different treatment. Adult participants with a diagnosis of myelofibrosis will be enrolled.
Around 230 participants will be enrolled in approximately 190 sites worldwide.
Participants will receive oral navitoclax tablet with oral ruxolitinib tablet or oral
ruxolitinib tablet with oral placebo (no active drug) tablet and treatment may continue
untill the participant cannot tolerate the study drug, or benefit is not achieved, or other
reasons which qualify for discontinuation of the study drug.
There may be a higher treatment burden for participants in this trial compared to their
standard of care. Participants will attend regular visits during the course of the study at a
hospital or clinic. The effect of the treatment will be checked by medical assessments, blood
tests, magnetic resonance imaging (MRI) or computed tomography (CT) scan, bone marrow tests,
checking for side effects, and completing questionnaires.