A Phase II Clinical Trial of Flonoltinib Maleate Tablet in Intermediate-High Risk Myelofibrosis
Key claim: A multicenter Phase II trial will randomize approximately 75 intermediate-2/high-risk myelofibrosis patients 1:1:1 to low-dose flonoltinib maleate, high-dose flonoltinib maleate, or ruxolitinib, stratified by DIPSS.
Abstract
This trial adopts a multicenter, open-label, positive drug parallel control clinical trial design, planning to enroll approximately 75 MF participants. Eligible participants will be stratified and assigned in a 1:1:1 ratio to the low-dose flonoltinib maleate tablet group, high-dose flonoltinib maleate tablet group, or the ruxolitinib tablet group. Stratification factor include the Dynamic International Prognostic Scoring System (DIPSS) risk classification (intermediate-2 and high risk)
Why this matters
A multicenter Phase II trial will randomize approximately 75 intermediate-2/high-risk myelofibrosis patients 1:1:1 to low-dose flonoltinib maleate, high-dose flonoltinib maleate, or ruxolitinib, stratified by DIPSS.