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New drug combo aims to prevent transplant complications in blood cancer patients

NCT ID NCT03320642

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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase trial tested whether adding the drug itacitinib to standard immune-suppressing medications could help prevent graft-versus-host disease (GVHD) in people receiving stem cell transplants for blood cancers. The study enrolled 84 participants with leukemia, lymphoma, or related conditions. The main goal was to see if blood cell recovery was safe when itacitinib was added to the usual GVHD prevention regimen.

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, this could point toward a safer way to prevent graft-versus-host disease after stem cell transplants.
What could go wrong
This was a very early (Phase 1) trial that was terminated early, so results are limited. It may not show clear benefit or safety over existing treatments.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

84 people

The number who actually took part.

Started

Feb 2018

Finished

Feb 2022

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: * Subjects with acute leukemia, chronic myelogenous leukemia, or myelodysplasia with no circulating blasts and \< 5% blasts in the bone marrow. * Subjects with non-Hodgkin lymphoma, including but not limited to chronic lymphocytic leukemia/small lymphocytic lymphoma, follicular, marginal zone, diffuse large B cell, or mantle cell lymphoma must have chemosensitive disease at time of transplant. Subjects with Hodgkin lymphoma with chemosensitive disease at the time of transplant. * Must be candidates for reduced-intensity conditioning regimens. * Must be candidates for peripheral blood stem cell transplants. * Karnofsky Performance Status score ≥ 70% or Eastern Cooperative Oncology Group Performance Status score of 0 to 2. * Serum creatinine ≤ 2.0 mg/dL or creatinine clearance ≥ 40 mL/min measured or calculated by Cockcroft-Gault equation. * Be willing to avoid pregnancy or fathering children. Exclusion Criteria: * Has previously received an allogenic hematopoietic stem cell transplant. * Presence of an active uncontrolled infection. * Known HIV infection. * Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection that requires treatment or at risk for HBV reactivation. * Prior malignancies. * Severe organ dysfunction. * Prior treatment with a JAK inhibitor or with an investigational agent, device, or procedure within 21 days of enrollment. * Currently breastfeeding. * Known allergies, hypersensitivity, or intolerance to any of the study medications. * Receipt of live (including attenuated) vaccines during the study, or anticipation of need for such a vaccine during the study. * History of primary idiopathic myelofibrosis or any severe marrow fibrosis that would prolong neutrophil engraftment to \> 28 days after transplant. * Post-transplant maintenance therapy for the hematologic malignancy or plans to initiate maintenance therapy during study treatment.

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Conditions

The condition(s) this trial relates to.

B-cell chronic lymphocytic leukemia graft versus host disease hematopoietic and lymphoid system neoplasm Hodgkins lymphoma Leukemia, Myelogenous, Chronic, BCR-ABL Positive mantle cell lymphoma myelodysplastic syndrome with excess blasts

As listed by the trial registrant

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

Hematologic malignancies

Contacts and locations

Locations

  • Anschutz Cancer Pavilion - University of Colorado

    Aurora, Colorado, 80045, United States

  • Azienda Ospedaliera San Gerardo Di Monza

    Monza, 20900, Italy

  • Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii (Presidio Papa Giovanni Xxiii)

    Bergamo, 24127, Italy

  • Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu

    Nantes, 44093, France

  • Chru de Lille Hopital Claude Huriez

    Lille, 59037, France

  • Chu Vandoeuvre-Les-Nancy, Hopital Brabois

    Vandœuvre-lès-Nancy, 54500, France

  • Comitato Di Bioetica Della Fondazione Irccs Policlinico San Matteo

    Pavia, 27100, Italy

  • Froedtert Hospital and the Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010, Spain

  • Hospital Puerta de Hierro

    Majadahonda, 28222, Spain

  • John Theurer Cancer Center, Hackensack University Medical Center

    Hackensack, New Jersey, 07601, United States

  • Loyola University Medical Center

    Maywood, Illinois, 60153, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • The Ohio State University

    Columbus, Ohio, 43210, United States

  • University of Maryland - Greenebaum Cancer Center

    Baltimore, Maryland, 21201, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

  • Winship Cancer Institute of Emory University

    Atlanta, Georgia, 30322, United States

More trials for these conditions

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