To Evaluate the Efficacy and Safety of Parsaclisib and Ruxolitinib in Participants With Myelofibrosis (LIMBER-313)
Hematopoietic Malignancies
Leukemia
Unknown Primary
18 Years and older, Male and Female
INCB 50465-313/LIMBER-313 (primary)
NCI-2021-01110
INCB 50465-313
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.
Eligibility
- Diagnosis of PMF, PPV-MF, or PET-MF.
- DIPSS risk category of intermediate-1, intermediate-2, or high.
- Palpable spleen of = 5 cm below the left costal margin on physical examination at the screening visit.
- Active symptoms of MF at the screening visit, as demonstrated by the presence of a TSS of = 10 using the Screening Symptom Form.
- Participants with an ECOG performance status score of 0, 1, or 2.
- Screening bone marrow biopsy specimen and pathology report(s) available that was obtained within the prior 2 months or willingness to undergo a bone marrow biopsy at screening/baseline; willingness to undergo bone marrow biopsy at Week 24 and every 24 weeks there after. Screening/baseline biopsy specimen must show diagnosis of MF.
- Life expectancy of at least 24 weeks.
- Willingness to avoid pregnancy or fathering children.
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