Momelotinib in Transfusion-Dependent Adults With Primary Myelofibrosis (PMF) or Post-polycythemia… (NCT02515630) | Clinical Trial Compass
CompletedPhase 2
Momelotinib in Transfusion-Dependent Adults With Primary Myelofibrosis (PMF) or Post-polycythemia Vera or Post-essential Thrombocythemia Myelofibrosis (Post-PV/ET MF)
United States41 participantsStarted 2016-01-29
Plain-language summary
This study will evaluate the transfusion independence response rate in transfusion-dependent adults with myelofibrosis after treatment with momelotinib (MMB).
Who can participate
Age range18 Years
SexALL
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Key Inclusion Criteria:
* Diagnosis of PMF or Post PV/ET-MF
* Requires myelofibrosis therapy, in the opinion of the investigator
* High risk OR intermediate-2 risk defined by dynamic international prognostic scoring system (DIPSS) OR intermediate-1 risk defined by DIPSS and associated with symptomatic splenomegaly and/or hepatomegaly
* Transfusion dependent at baseline, defined as ≥ 4 U red blood cell (RBC) transfusion in the 8 weeks prior to first dose of MMB
* Acceptable organ function as evidenced by the following:
* Platelet Count ≥ 50 x 10\^9/L
* Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) ≤ 3 x upper limit of normal (ULN) or AST or ALT ≤ 5 x ULN if liver is involved by disease process as judged by the investigator
* Serum creatinine ≤ 2.0 mg/dL or calculated creatinine clearance of ≥ 60 mL/min
* Direct bilirubin ≤ 2.0 x ULN
* Life expectancy of \> 24 weeks
* Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
* Lactating females must agree to discontinue nursing before MMB administration
* Able to understand and willing to sign the informed consent form
Key Exclusion Criteria:
* Prior splenectomy
* Splenic irradiation within 3 months prior to the first dose of MMB
* Prior treatment with MMB
* Known positive status of human immunodeficiency virus (HIV)
* Chronic active or acute viral hepatitis A, B, or C infection (testing required …