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New drug combo shows promise for rare blood cancer

NCT ID NCT04817007

Disease control Sponsor: Bristol-Myers Squibb 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Updated 1 time

Summary

This study tests a new drug called BMS-986158, either alone or combined with standard treatments (ruxolitinib or fedratinib), in about 216 people with high-risk myelofibrosis, a type of blood cancer. The goal is to see if the drug is safe and can shrink an enlarged spleen, a common problem in this disease. The trial is currently active but not recruiting new participants.

What this could mean

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

Active substance
BMS-986158 (a drug being tested) combined with either ruxolitinib or fedratinib (standard drugs for myelofibrosis)
What this could lead to
If this works, it could offer a new treatment option for people with high-risk myelofibrosis, potentially shrinking an enlarged spleen and improving symptoms.
What could go wrong
This is an early-phase trial (Phase 1b/2) with a small number of participants, so the drug may not prove effective or safe. Side effects could be serious, and the combination might not work better than 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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 216 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2021

Expected to finish

Aug 2028

An estimate. End dates often move.

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 myelofibrosis (PMF), post-essential thrombocythemia (ET) or post-polycythemia vera (PV) myelofibrosis * Treatment-related toxicities from prior therapy resolved to Grade 1 or pre-treatment baseline or determined to be irreversible prior to study treatment * Must agree to follow specific methods of contraception, if applicable Exclusion Criteria: * Women who are pregnant or breastfeeding at screening * Any significant acute or uncontrolled chronic medical illness Other protocol-defined inclusion/exclusion criteria apply

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Conditions

The condition(s) this trial relates to.

myelofibrosis primary myelofibrosis

As listed by the trial registrant

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

Myelofibrosis

Contacts and locations

Locations

  • Local Institution - 0001

    Florence, 50134, Italy

  • Local Institution - 0002

    Brescia, 25123, Italy

  • Local Institution - 0003

    Bologna, 40138, Italy

  • Local Institution - 0006

    Heidelberg, Victoria, 3084, Australia

  • Local Institution - 0007

    East Melbourne, Victoria, 3002, Australia

  • Local Institution - 0008

    Marseille, 13273, France

  • Local Institution - 0010

    Villejuif, 94800, France

  • Local Institution - 0011

    Paris, 75010, France

  • Local Institution - 0012

    Verona, 37134, Italy

  • Local Institution - 0015

    West Perth, Western Australia, 6005, Australia

  • Local Institution - 0016

    Jerusalem, 9112001, Israel

  • Local Institution - 0017

    Ramat Gan, 5262100, Israel

  • Local Institution - 0018

    Petah Tikva, 4910021, Israel

  • Local Institution - 0019

    Tel Aviv, 6423906, Israel

  • Local Institution - 0020

    Badalona, Barcelona [Barcelona], 08916, Spain

  • Local Institution - 0021

    Salamanca, 37007, Spain

  • Local Institution - 0026

    Madrid, 28041, Spain

  • Local Institution - 0027

    Nice, 06202, France

  • Local Institution - 0029

    Santander, Cantabria, 39008, Spain

  • Local Institution - 0030

    Brest, 29200, France

  • Local Institution - 0032

    Wollongong, New South Wales, 2500, Australia

  • Local Institution - 0033

    Ann Arbor, Michigan, 48109, United States

  • Local Institution - 0035

    Halle, Saxony-Anhalt, 06120, Germany

  • Local Institution - 0036

    Blacktown, New South Wales, 2148, Australia

  • Local Institution - 0038

    Worcester, Massachusetts, 01655, United States

  • Local Institution - 0039

    Essen, North Rhine-Westphalia, 45122, Germany

  • Local Institution - 0040

    Chemnitz, Saxony, 09116, Germany

  • Local Institution - 0041

    Nedlands, Western Australia, 6009, Australia

  • Local Institution - 0042

    Pittsburgh, Pennsylvania, 15224, United States

  • Local Institution - 0043

    New Orleans, Louisiana, 70112, United States

  • Local Institution - 0045

    Hackensack, New Jersey, 07601, United States

  • Local Institution - 0047

    Thessaloniki, Thessaloníki, 570 10, Greece

  • Local Institution - 0048

    Seoul, Seoul-teukbyeolsi [Seoul], 05505, South Korea

  • Local Institution - 0049

    Seongnam, Kyǒnggi-do, 13620, South Korea

  • Local Institution - 0050

    Lübeck, Schleswig-Holstein, 23538, Germany

  • Local Institution - 0051

    Cluj-Napoca, 400015, Romania

  • Local Institution - 0052

    Bucuresti, Cluj, 022328, Romania

  • Local Institution - 0053

    Seoul, Seoul-teukbyeolsi [Seoul], 06591, South Korea

  • Local Institution - 0054

    Madrid, Madrid, Comunidad de, 28034, Spain

  • Local Institution - 0061

    Chaïdári, Attikí, 12462, Greece

  • Local Institution - 0062

    Gdansk, 80-952, Poland

  • Local Institution - 0068

    Erding, Bavaria, 85435, Germany

  • Local Institution - 0069

    Newport Beach, California, 92663, United States

  • Local Institution - 0076

    Chapel Hill, North Carolina, 27514, United States

  • Local Institution - 0077

    Słupsk, Pomeranian Voivodeship, 76-200, Poland

  • Local Institution - 0083

    Bucharest, 050098, Romania

  • Local Institution - 0086

    Beersheba, Southern District, 8410101, Israel

  • Local Institution - 0090

    Lake Mary, Florida, 32746, United States

  • Local Institution - 0094

    Valencia, 46026, Spain

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