To Evaluate the Efficacy and Safety of Parsaclisib and Ruxolitinib in Participants With Myelofibrosis (LIMBER-313)

Active:	No
Cancer Type:	Hematopoietic Malignancies Leukemia Unknown Primary	NCT ID:	NCT04551066
Trial Phases:	Phase III	Protocol IDs:	INCB 50465-313/LIMBER-313 (primary) NCI-2021-01110 INCB 50465-313
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Incyte Corporation
NCI Full Details:	http://clinicaltrials.gov/show/NCT04551066

Summary

The purpose of the study is to compare the efficacy of parsaclisib when combined with
ruxolitinb versus placebo combined with ruxolitinib in participants with myelofibrosis.

Objectives

This is a Phase 3, randomized, double-blind study of the combination of the PI3Kd inhibitor
parsaclisib or matching placebo and the JAK1/2 inhibitor ruxolitinib in participants with PMF
or secondary MF (PPV-MF or PET-MF) with DIPSS risk category of intermediate or high.
Prospective participants must have not received prior MF therapy with a JAK inhibitor or a
PI3K inhibitor. After participants have been determined to be eligible for the study and
completed the baseline symptom diary assessment for 7 days, they will be randomized to 1 of 2
treatment groups, with stratification for platelet count (= 100 × 10^9/L vs 50 to < 100 ×
10^9/L inclusive) and DIPSS risk category (high vs intermediate-2 vs intermediate-1).

Once all enrolled participants completed the week 24 assessments the study will be unblinded
and and participants randomized to placebo will have the opportunity to cross over to begin
receiving parsaclisib, together with continued ruxolitinib, as long as hematology parameters
are adequate.

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