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.

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.