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New drug itacitinib tested for Hard-to-Treat myelofibrosis

NCT ID NCT04629508

Disease control Sponsor: Incyte Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This phase 2 study tested the drug itacitinib in 4 people with myelofibrosis (a bone marrow disorder) who had already tried other treatments like ruxolitinib or fedratinib. The main goals were to check safety and find the right dose, and to see if it could shrink an enlarged spleen. The study is now complete, but with only 4 participants, it provides very early information.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
itacitinib
What this could lead to
If it works, itacitinib could offer a new treatment option for myelofibrosis patients who no longer respond to or cannot tolerate current therapies.
What could go wrong
This is a very small, early-phase study (only 4 participants) focused on safety and dosing. It is not designed to prove effectiveness, and results may not apply to larger populations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

4 people

The number who actually took part.

Started

Jul 2021

Finished

Aug 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 * 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.

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Conditions

The condition(s) this trial relates to.

acquired polycythemia vera familial thrombocytosis myelofibrosis Myeloproliferative Disorders primary myelofibrosis thrombocytosis disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Myelofibrosis Polycythemia vera Thrombocythemia

Contacts and locations

Locations

  • AZ DELTA

    Roeselare, 08800, Belgium

  • Aou San Giovanni Di Dio E Ruggi

    Salerno, 84131, Italy

  • Baptist Cancer Center

    Memphis, Tennessee, 38120, United States

  • Chu Ucl Namur University Hospital Mont-Godinne

    Yvoir, 05530, Belgium

  • Cliniques Universitaires Ucl Saint-Luc

    Brussels, 01000, Belgium

  • Hospital Universitari I Politecnic La Fe

    Valencia, 46000, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Interne 1 - Hematologie Mit Stammzelltransplantation, Hemostaseologie Und Medizinische Onkologie Ord

    Linz, 70376, Austria

  • Istituto Di Ricovero E Cura A Carattere Scientifico (Irccs) Ospedale San Raffaele

    Milan, 20132, Italy

  • Jessa Ziekenhuis

    Hasselt, 03500, Belgium

  • Midamerica Cancer Care

    Kansas City, Missouri, 64114, United States

  • New Jersey Hematology Oncology Associates Llc

    Brick, New Jersey, 08724-3009, United States

  • Pratia Hematologia Katowice

    Katowice, 40-519, Poland

  • Rcca Md, Llc

    Bethesda, Maryland, 20817, United States

  • Renovatio Clinical Consultants Llc

    Spring, Texas, 77380, United States

  • Texas Oncology - Baylor Sammons Cancer Center

    Dallas, Texas, 75246-2092, United States

  • Treviso Hospital

    Treviso, 31100, Italy

  • Tulane University

    New Orleans, Louisiana, 70112, United States

  • Universitaetsmedizin Greifswald

    Greifswald, 17475, Germany

  • Universitatsklinikum Halle (Saale)

    Halle, 06120, Germany

  • Vanderbilt University

    Nashville, Tennessee, 37235, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.