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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) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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)

A 2-Part, Phase 2, Open-Label Study of the Safety, Tolerability, and Efficacy of Itacitinib Immediate Release in Participants With Primary Myelofibrosis or Secondary Myelofibrosis (Post-Polycythemia Vera Myelofibrosis or Post-Essential Thrombocythemia Myelofibrosis) Who Have Received Prior Ruxolitinib and/or Fedratinib Monotherapy

NCT04629508•Incyte Corporation

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.

Exclusion Criteria

•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
+7 more criteria

Locations (21)

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

Key Dates

Start Date

July 12, 2021

Primary Completion Date

August 24, 2023

Completion Date

August 24, 2023

Last Updated

September 2, 2025

Enrollment

ACTUAL participants

Conditions

MyelofibrosisPolycythemia VeraThrombocythemia

Interventions

itacitinib

DRUG

Bomedemstat vs Hydroxyurea for Essential Thrombocythemia (MK-3543-007)

NCT06456346

Essential Thrombocythemia

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RECRUITINGPHASE2

A Platform Protocol to Investigate Post-Transplant Cyclophosphamide-Based Graft-Versus-Host Disease Prophylaxis in Patients With Hematologic Malignancies Undergoing Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation

NCT06859424

AML (Acute Myelogenous Leukemia)Acute Lymphoid Leukemia (ALL)+9 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 2, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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)

Inclusion Criteria

Exclusion Criteria

Bomedemstat vs Hydroxyurea for Essential Thrombocythemia (MK-3543-007)

A Platform Protocol to Investigate Post-Transplant Cyclophosphamide-Based Graft-Versus-Host Disease Prophylaxis in Patients With Hematologic Malignancies Undergoing Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation

A Phase 1 Study of AJ1-11095 in Patients With Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (PPV-MF), or Post-Essential Thrombocythemia Myelofibrosis (PET-MF) Who Have Been Failed by a Type I JAK2 Inhibitor (JAK2i)

An Optimal Dose Finding Study of N-Acetylcysteine in Patients With Myeloproliferative Neoplasms

Momelotinib During and After HCT in Myelofibrosis

National Longitudinal Cohort of Hematological Diseases