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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Myelofibrosis, Primary Myelofibrosis, Post Essential Thrombocythemia Myelofibrosis, Post Polycythemia Vera Myelofibrosis

In brief

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 facts

Study ID

NCT04551066

Run by

Incyte Corporation

People needed

252

Starts

2021-05-24

Expected to finish

2024-11-25

Last updated by the study team

2025-10-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).
• Use of experimental drug therapy for MF or any other standard drug (eg, danazol, hydroxyurea) used for MF within 3 months of starting study drug and/or lack of recovery from all toxicities from previous therapy to ≤ Grade 1.
• Inability to swallow food or any condition of the upper gastrointestinal tract that precludes administration of oral medications.
• Recent history of inadequate bone marrow reserve.
• Inadequate liver and renal function at screening.
• Active bacterial, fungal, parasitic, or viral infection that requires therapy.
• Active HBV or HCV infection that requires treatment or at risk for HBV reactivation.
• Known HIV infection.
• Uncontrolled, severe, or unstable cardiac disease that in the investigator's opinion may jeopardize the safety of the participant or compliance with the Protocol.
• Active invasive malignancy over the previous 2 years.
• Splenic irradiation within 6 months before receiving the first dose of study drug.
• Concurrent use of any prohibited medications.
• Active alcohol or drug addiction that would interfere with the ability to comply with the study requirements.
• Use of any potent CYP3A4 inhibitors or inducers within 14 days or 5 half lives(whichever is longer) before the first dose of study drug or anticipated during the study.
• Inadequate recovery from toxicity and/or complications from a major surgery before starting therapy.
• Currently breastfeeding or pregnant.
• Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
• History of Grade 3 or 4 irAEs from prior immunotherapy.
• Receipt of any live vaccine within 30 days of the first dose of study drug

Where it is running

• Mayo Clinic Rochester — Phoenix, Arizona, United States
• Sutter Health Alta Bates Summit Medical Center Absmc Alta Bates Summit Comprehensive Cancer Center — Berkeley, California, United States
• CCARE — Fresno, California, United States
• California Research Institute (Cri) — Los Angeles, California, United States
• UCLA School of Medicine — Los Angeles, California, United States
• Scripps Clinic — San Diego, California, United States
• Coastal Integrated Cancer Care-Cicc — San Luis Obispo, California, United States
• Stamford Hospital-Medical Oncology Hematology — Stamford, Connecticut, United States
• Georgetown University — Washington D.C., District of Columbia, United States
• Emory University — Atlanta, Georgia, United States
• University of Kansas Hospital Authority — Westwood, Kansas, United States
• University of Kentucky-Markey Cancer Center — Lexington, Kentucky, United States
• Tulane University — New Orleans, Louisiana, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Midamerica Cancer Care — Kansas City, Missouri, United States
• New Jersey Hematology Oncology Associates Llc — Brick, New Jersey, United States
• Morristown Medical Center-Atlantic Health System — Morristown, New Jersey, United States
• Roswell Park Cancer Institute — Buffalo, New York, United States
• Westchester Medical Center Advanced Oncology and Infusion Center — Hawthorne, New York, United States
• Mount Sinai School of Medicine — New York, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Duke Cancer Center — Durham, North Carolina, United States
• Alaska Oncology and Hematology — Anchorage, Alaska, United States

Full record on ClinicalTrials.gov

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