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

Part of paid clinical trials in Anchorage, Alaska.

Sponsor
Incyte Corporation
Study ID
NCT04551066
Phase
PHASE3
Status
Terminated

Conditions

  • Myelofibrosis
  • Post Essential Thrombocythemia Myelofibrosis
  • Post Polycythemia Vera Myelofibrosis
  • Primary Myelofibrosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • parsaclisib — DRUG
    parsaclisib will be administered QD orally
  • ruxolitinib — DRUG
    ruxolitinib will be administered BID orally
  • placebo — DRUG
    placebo will be administered QD orally

Study Details

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.

Key Dates

Start date
May 24, 2021
Status verified
Sep 2025
Primary completion
Aug 3, 2023
Completion
Nov 25, 2024

Study Design

Enrollment
252 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group A : parsaclisib + ruxolitinib
    Participants will receive parsaclisib and ruxolitinib starting from Day 1 for the duration of study, ruxolitinib dose will be determined by baseline platelet count.
  • Placebo Comparator: Group B : placebo + ruxolitinib
    Participants will receive placebo and ruxolitinib starting from Day 1 for the duration of study, ruxolitinib dose will be determined by baseline platelet count.

Primary Outcome Measure

Percentage of Participants Achieving ≥35% Reduction in Spleen Volume From Baseline to Week 24 as Measured by Magnetic Resonance Imaging [MRI] (or Computed Tomography [CT] Scan in Applicable Participants) [ Time Frame: Baseline; Week 24 ]

Locations (36)

FacilityCityStateZIPSite coordinators
Alaska Oncology and HematologyAnchorageAlaska99508-
Mayo Clinic RochesterPhoenixArizona85054-
Sutter Health Alta Bates Summit Medical Center Absmc Alta Bates Summit Comprehensive Cancer CenterBerkeleyCalifornia94704-
CCAREFresnoCalifornia93720-
California Research Institute (Cri)Los AngelesCalifornia90027-6005-
UCLA School of MedicineLos AngelesCalifornia90095-3075-
Scripps ClinicSan DiegoCalifornia92103-
Coastal Integrated Cancer Care-CiccSan Luis ObispoCalifornia93401-
Stamford Hospital-Medical Oncology HematologyStamfordConnecticut06904-
Georgetown UniversityWashington D.C.District of Columbia20057-
Emory UniversityAtlantaGeorgia30322-
University of Kansas Hospital AuthorityWestwoodKansas66205-
University of Kentucky-Markey Cancer CenterLexingtonKentucky40536-
Tulane UniversityNew OrleansLouisiana70112-
Johns Hopkins UniversityBaltimoreMaryland21287-
Massachusetts General HospitalBostonMassachusetts02114-
Midamerica Cancer CareKansas CityMissouri64114-
New Jersey Hematology Oncology Associates LlcBrickNew Jersey08724-
Morristown Medical Center-Atlantic Health SystemMorristownNew Jersey07960-
Roswell Park Cancer InstituteBuffaloNew York14263-
Westchester Medical Center Advanced Oncology and Infusion CenterHawthorneNew York10532-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Mount Sinai School of MedicineNew YorkNew York10029-
Montefiore Medical CenterThe BronxNew York10467-
Duke Cancer CenterDurhamNorth Carolina27710-
Wake Forest Baptist Medical CenterWinston-SalemNorth Carolina27157-
Ohio State UniversityColumbusOhio43210-
Kaiser Permanente-NorthwestPortlandOregon97227-
Oregon Health & Science UniversityPortlandOregon97239-
Avera Cancer InstituteSioux FallsSouth Dakota57103-
Texas Oncology-Baylor Sammons Cancer CenterDallasTexas75246-2092-
Houston Methodist HospitalHoustonTexas77030-
Kelsey Seybold ClinicHoustonTexas77025-
Renovatio ClinicalSpringTexas77380-
Providence Regional Medical Center EverettEverettWashington98201-
Seattle Cancer Care AllianceSeattleWashington98109-

Find similar trials in Anchorage, AK

By research site
Alaska Oncology and Hematology· Anchorage, AKMayo Clinic Rochester· Phoenix, AZSutter Health Alta Bates Summit Medical Center Absmc Alta Bates Summit Comprehensive Cancer Center· Berkeley, CACCARE· Fresno, CACalifornia Research Institute (Cri)· Los Angeles, CAUCLA School of Medicine· Los Angeles, CA

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