To Assess the Safety, Tolerability and Efficacy of Itacitinib Immediate Release Tablets in Participants With Primary or Secondary Myelofibrosis Who Have Received Prior Ruxolitinib and/or Fedratinib Monotherapy (LIMBER-213)
Completed · Phase 2
Conditions studied: Myelofibrosis, Polycythemia Vera, Thrombocythemia
In brief
This is a 2-part study. In Part 1, participants will be dosed at 2 different dose levels in order to select the RP2D for Part 2 of the study.
Key facts
- Study ID
- NCT04629508
- Run by
- Incyte Corporation
- People needed
- 4
- Starts
- 2021-07-12
- Expected to finish
- 2023-08-24
- Last updated by the study team
- 2025-09-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosis of primary MF meeting the 2016 WHO criteria for overt PMF or secondary MF (PPV-MF or PET-MF) meeting the 2008 IWG-MRT criteria.
- At least Intermediate 1 risk MF according to the DIPSS.
- Prior treatment with ruxolitinib and/or fedratinib monotherapy
- Currently receiving ruxolitinib or fedratinib monotherapy for PMF or secondary MF.
- Splenomegaly defined as palpable spleen at least 5 cm below the left costal margin or volume ≥ 450 cm3 on imaging assessed during screening.
- Allogeneic stem cell transplant not planned.
- Platelet is greater than or equal to 50 × 109/L at screening.
- Ability to comprehend and willingness to sign a written ICF for the study.
- Willingness to avoid pregnancy or fathering children.
You may not qualify if…
- Prior treatment with a JAK inhibitor other than ruxolitinib or fedratinib
- Record of ≥ 10% myeloid blasts in the peripheral blood (on peripheral blood smear) or bone marrow prior to or at the time of screening
- For participants on ruxolitinib or fedratinib, unable to be tapered from that treatment over the course of 14 days without corticosteroids, hydroxyurea, or other agents
- Treatment with ruxolitinib, fedratinib or other MF-directed therapy (approved or investigational) within 2 weeks of Day 1
- Prior splenectomy or splenic irradiation within 6 months before receiving the first dose of itacitinib
- Unable or unwilling to undergo serial MRI or CT scans for spleen volume measurement
- Unable or unwilling to complete MFSAF v4.0 diary on a daily basis during the study
- ECOG performance status ≥ 3
- Life expectancy less than 24 weeks
- Not willing to receive RBC or platelet transfusions
- Participants with laboratory values at screening outside of protocol defined ranges
- Significant concurrent, uncontrolled medical condition
- Participants with impaired cardiac function or clinically significant cardiac disease unless approved by medical monitor/sponsor
- History or presence of an abnormal ECG that, in the investigator's opinion, is clinically meaningful
- Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment.
- Evidence of HBV or HCV infection or risk of reactivation
- Known HIV infection.
Where it is running
- Tulane University — New Orleans, Louisiana, United States
- Rcca Md, Llc — Bethesda, Maryland, United States
- Midamerica Cancer Care — Kansas City, Missouri, United States
- New Jersey Hematology Oncology Associates Llc — Brick, New Jersey, United States
- Baptist Cancer Center — Memphis, Tennessee, United States
- Vanderbilt University — Nashville, Tennessee, United States
- Texas Oncology - Baylor Sammons Cancer Center — Dallas, Texas, United States
- Renovatio Clinical Consultants Llc — Spring, Texas, United States
- Interne 1 - Hematologie Mit Stammzelltransplantation, Hemostaseologie Und Medizinische Onkologie Ord — Linz, Austria
- Cliniques Universitaires Ucl Saint-Luc — Brussels, Belgium
- Jessa Ziekenhuis — Hasselt, Belgium
- AZ DELTA — Roeselare, Belgium
- Chu Ucl Namur University Hospital Mont-Godinne — Yvoir, Belgium
- Universitaetsmedizin Greifswald — Greifswald, Germany
- Universitatsklinikum Halle (Saale) — Halle, Germany
- Istituto Di Ricovero E Cura A Carattere Scientifico (Irccs) Ospedale San Raffaele — Milan, Italy
- Aou San Giovanni Di Dio E Ruggi — Salerno, Italy
- Treviso Hospital — Treviso, Italy
- Pratia Hematologia Katowice — Katowice, Poland
- Hospital Universitario 12 de Octubre — Madrid, Spain
- Hospital Universitari I Politecnic La Fe — Valencia, Spain
Full record on ClinicalTrials.gov
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