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To Evaluate the Efficacy and Safety of Parsaclisib and Ruxolitinib in Participants With Myelofibrosis (LIMBER-313)
Overall Recruitment Status: Active, currently enrolling
 
Official Title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of the Combination of PI3Kd Inhibitor Parsaclisib and Ruxolitinib in Participants With Myelofibrosis
 
Region Sponsors
Northwest
Incyte Corporation
 
Acronym KP IRB No.
LIMBER-313 1702471
 
Study Type Phase
Clinical Trial Phase III
 
Study Population Description
(Adult, Older Adult) with Myelofibrosis, Primary Myelofibrosis, Post Essential Thrombocythemia Myelofibrosis, Post Polycythemia Vera Myelofibrosis
 
Purpose
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.
 
Detailed Description
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.
 
Gender Age Limit
Male & Female 18 years & older
 
Inclusion Criteria
  • 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
  • Please contact study team for additional inclusion/exclusion criteria
 
Exclusion Criteria
  • Prior use of any JAK inhibitor
  • Prior therapy with any drug that inhibits PI3K (examples of drugs targeting this pathway include but are not limited to INCB040093, idelalisib, duvelisib, buparlisib, copanlisib, and umbralisib)
  • Please contact study team for additional inclusion/exclusion criteria

 
Keywords and/or Specific Medical Conditions
  • Blood Coagulation Disorders
  • Neoplasms
  • Blood Platelet Disorders
  • Neoplasms by Site
  • Bone Marrow Diseases
  • Polycythemia
  • Bone Marrow Neoplasms
  • Polycythemia Vera
  • Hematologic Diseases
  • Primary Myelofibrosis
  • Hematologic Neoplasms
  • Thrombocythemia, Essential
  • Hemorrhagic Disorders
  • Thrombocytosis
  • Myeloproliferative Disorders
  • Oncology (Adult)
 
KP Clinical Facility
  • Central Interstate Medical Office
 
Clinical Area
  • Oncology (Adult)


Principal Investigator:
Abdul-Hai Mansoor, MD
Contact Information:
- Rhonda Stephenson, RN
-5033356310
-rhonda.stephenson@kpchr.org
-Central Interstate Medical Office


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