Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Key Eligibility Criteria: Prior JAKi Arm 1 and Add-on to JAKi Arm 2 Inclusion criteria
Patients with confirmed diagnosis of MF who meet all of the following criteria:
• Dynamic International Prognostic Scoring System (DIPSS) risk category of intermediate-2 or
higher.
• Platelet count ≥ 75 x 109/L without the assistance of thrombopoietic factors or transfusions
• ANC ≥ 1 x 109/L without the assistance of granulocyte growth factors
• Spleen volume of ≥450 cm3 by CT or MRI for Cohorts 1B and 2B OR RBC TD (defined as an
average of ≥2 units of RBC transfusions per month over the 12 weeks prior to enrollment) for
Cohorts 1A and 2A
• Peripheral blood blast count <10%
• At least 2 symptoms measurable (score ≥ 1) using the MFSAF v4.0
• Monotherapy Arm (Arm 1) patients only: Previously treated with a JAKi and be intolerant, resistant,
refractory or lost response to the JAKi; have not received the JAKi within 2 weeks prior to start of
study drug, or are ineligible to be treated with a JAKi
• Combination Arm (Arm 2) patients only: Must have received ruxolitinib for at least 6 months and be
on a stable ruxolitinib dose for a minimum 8 weeks (prior to start of study drug)
ECOG performance status ≤ 2.
Serum direct bilirubin ≤ 1.5 x upper limit of normal (ULN), aspartate aminotransferase (AST) and
alanine aminotransferase (ALT) ≤ 2.5 x ULN. The AST and /or ALT may be elevated up to 5 x ULN if the
elevation can be reasonably ascribed to liver involvement.
Calculated or measured creatinine clearance (CrCl) ≥ 45 ml/min
No prior treatment with any bromodomain and extra-terminal domain (BET) inhibitor
Key Eligibility Criteria: JAKi Naïve Arm 3 Inclusion criteria
Patients with confirmed diagnosis of MF who meet all of the following criteria:
• DIPSS risk category of intermediate-2 or higher
• Platelet count ≥ 100 x 109/L without the assistance of thrombopoietic factors or transfusions
• ANC ≥ 1 x 109/L without the assistance of granulocyte growth factors
• Spleen volume of ≥ 450 cm3 by CT/MRI
• Peripheral blood blast count <10%
• At least 2 symptoms measurable (score ≥ 3) or a total score of ≥ 10 using the MFSAF v4.0
• No prior treatment with JAKi allowed
ECOG performance status ≤ 2.
Life expectancy of >24 weeks.
Serum direct bilirubin < 2.0 x ULN; AST and ALT ≤ 2.5 x ULN. The AST and /or ALT may be
elevated up to 5 x ULN if the elevation can be reasonably ascribed to liver involvement
Calculated or measured CrCl ≥ 45 ml/min
No prior treatment with any BET inhibitor