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New combo pill aims to shrink spleens and ease symptoms in bone marrow cancer

NCT ID NCT07357727

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 18, 2026 · Updated 21 times

Summary

This phase 3 trial tests whether adding pelabresib to the standard drug ruxolitinib works better than ruxolitinib alone for people with myelofibrosis, a type of bone marrow cancer. About 460 adults who have not taken JAK inhibitors before will receive either the combination or a placebo plus ruxolitinib. The main goals are to see if the combination shrinks the spleen and reduces symptoms like pain and fatigue.

What this could mean

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

Active substance
pelabresib (a drug) combined with ruxolitinib (a drug)
What this could lead to
If it works, this combination could offer better control of myelofibrosis by shrinking the spleen and easing symptoms more than the current standard treatment.
What could go wrong
This is a large phase 3 trial, but the added benefit of pelabresib is unproven. Side effects from the combination could be worse than ruxolitinib alone, and the results may not apply to all patients.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 460 people

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

Started

Jun 2026

Expected to finish

Dec 2030

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.

Key Inclusion Criteria: * Participants have diagnosis of primary myelofibrosis (PMF) or post-polycythemia vera myelofibrosis (post-PV MF) or post-essential thrombocythemia myelofibrosis (post-ET MF) according to the International Consensus Classification (ICC) of Myeloid Neoplasms and Acute Leukemias 2022 * DIPSS risk category of intermediate-1, intermediate-2 or high-risk * Spleen volume ≥ 450 cm3 by CT or MRI scan (local read sufficient if no central read available) * Have an average TSS of ≥15 within 7 days prior to randomization, using MFSAF v. 4.0 (at least 4 out of 7 TSS assessments required for average calculation) * Participants with an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 * Blasts \<5% in peripheral blood. Assessment of blasts in peripheral blood is mandatory at screening * Platelet count ≥ 100 x 10\^9/L in the absence of growth factors or transfusions for the previous 4 weeks Key Exclusion Criteria: * Prior splenectomy at any time or splenic irradiation in the previous 6 months * Prior hematopoietic cell transplant or participant anticipated to receive a hematopoietic cell transplant within 24 weeks from the date of randomization * Blasts ≥ 5% in bone marrow if results available at screening or history of accelerated phase (AP) or leukemic transformation * History of a malignancy (other than MF, PPV-MF or PET-MF) in the past 3 years in need of systemic treatment * Received any approved or investigational agent other than hydroxyurea or anagrelide for the treatment of MF within 14 days of first dose of study treatment or within 5 half-lives of the approved or investigational agent, whichever is longer * Prior treatment with any JAK inhibitor or Bromodomain and extraterminal domain (BET) inhibitor Other protocol-defined inclusion/exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

primary myelofibrosis

As listed by the trial registrant

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

Post-essential thrombocythemia myelofibrosis (pet-MF) Post-polycythemia vera myelofibrosis (PPV-MF) Primary myelofibrosis (PMF)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    77 sites in 13 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Franciscan Health Indianapolis

    RECRUITING

    Indianapolis, Indiana, 42637, United States

  • Fred Hutch Cancer Research

    RECRUITING

    Seattle, Washington, 98109, United States

  • MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • New York Oncology Hematology P C

    RECRUITING

    Albany, New York, 12206, United States

  • Novartis Investigative Site

    RECRUITING

    Buenos Aires, Buenos Aires F.D., 1221, Argentina

  • Novartis Investigative Site

    RECRUITING

    CABA, C1181ACH, Argentina

  • Novartis Investigative Site

    RECRUITING

    Capital Federal, C1114AAN, Argentina

  • Novartis Investigative Site

    RECRUITING

    Córdoba, X5016KEH, Argentina

  • Novartis Investigative Site

    RECRUITING

    Adelaide, South Australia, 5000, Australia

  • Novartis Investigative Site

    RECRUITING

    Clayton, Victoria, 3168, Australia

  • Novartis Investigative Site

    RECRUITING

    Hefei, Anhui, 230001, China

  • Novartis Investigative Site

    RECRUITING

    Guangzhou, Guangdong, 510080, China

  • Novartis Investigative Site

    RECRUITING

    Guangzhou, Guangdong, 510515, China

  • Novartis Investigative Site

    RECRUITING

    Wuhan, Hubei, 430022, China

  • Novartis Investigative Site

    RECRUITING

    Wuhan, Hubei, 430030, China

  • Novartis Investigative Site

    RECRUITING

    Nanjing, Jiangsu, 210029, China

  • Novartis Investigative Site

    RECRUITING

    Nantong, Jiangsu, 226000, China

  • Novartis Investigative Site

    RECRUITING

    Changchun, Jilin, 130021, China

  • Novartis Investigative Site

    RECRUITING

    Jinan, Shandong, 250012, China

  • Novartis Investigative Site

    RECRUITING

    Yantai, Shandong, 264000, China

  • Novartis Investigative Site

    RECRUITING

    Kunming, Yunnan, 650101, China

  • Novartis Investigative Site

    RECRUITING

    Hangzhou, Zhejiang, 310003, China

  • Novartis Investigative Site

    RECRUITING

    Wenzhou, Zhejiang, 325000, China

  • Novartis Investigative Site

    RECRUITING

    Beijing, 100730, China

  • Novartis Investigative Site

    RECRUITING

    Chongqing, 400016, China

  • Novartis Investigative Site

    RECRUITING

    Fuzhou, 350001, China

  • Novartis Investigative Site

    RECRUITING

    Shanghai, 200025, China

  • Novartis Investigative Site

    RECRUITING

    Shenyang, 110004, China

  • Novartis Investigative Site

    RECRUITING

    Tianjin, 300020, China

  • Novartis Investigative Site

    RECRUITING

    Aurangabad, Maharashtra, 431005, India

  • Novartis Investigative Site

    RECRUITING

    Pune, Maharashtra, 411006, India

  • Novartis Investigative Site

    RECRUITING

    Rishikesh, Uttarakhand, 249203, India

  • Novartis Investigative Site

    RECRUITING

    Kolkata, West Bengal, 700014, India

  • Novartis Investigative Site

    RECRUITING

    Delhi, 110085, India

  • Novartis Investigative Site

    RECRUITING

    Padova, PD, 35128, Italy

  • Novartis Investigative Site

    RECRUITING

    Verona, VR, 37134, Italy

  • Novartis Investigative Site

    RECRUITING

    Sapporo, Hokkaido, 0030006, Japan

  • Novartis Investigative Site

    RECRUITING

    Kobe, Hyōgo, 6500047, Japan

  • Novartis Investigative Site

    RECRUITING

    Shiwa-Gun, Iwate, 0283695, Japan

  • Novartis Investigative Site

    RECRUITING

    Bunkyo Ku, Tokyo, 1138431, Japan

  • Novartis Investigative Site

    RECRUITING

    Chūō, Yamanashi, 4093898, Japan

  • Novartis Investigative Site

    RECRUITING

    Fukuoka, 8128582, Japan

  • Novartis Investigative Site

    RECRUITING

    Miyazaki, 8891692, Japan

  • Novartis Investigative Site

    RECRUITING

    George Town, Pulau Pinang, 10450, Malaysia

  • Novartis Investigative Site

    RECRUITING

    Kota Kinabalu, Sabah, 88586, Malaysia

  • Novartis Investigative Site

    RECRUITING

    Kuching, Sarawak, 93586, Malaysia

  • Novartis Investigative Site

    RECRUITING

    Johor Bahru, 80100, Malaysia

  • Novartis Investigative Site

    RECRUITING

    Kuala Selangor, 68000, Malaysia

  • Novartis Investigative Site

    RECRUITING

    Katowice, 40-519, Poland

  • Novartis Investigative Site

    RECRUITING

    Skorzewo, 60-185, Poland

  • Novartis Investigative Site

    RECRUITING

    Suwon, Gyeonggi-do, 442-723, South Korea

  • Novartis Investigative Site

    RECRUITING

    Jeonju, Jeollabuk-do, 54907, South Korea

  • Novartis Investigative Site

    RECRUITING

    Seoul, Yangcheon Gu, 07985, South Korea

  • Novartis Investigative Site

    RECRUITING

    Busan, 49241, South Korea

  • Novartis Investigative Site

    RECRUITING

    Seoul, 03080, South Korea

  • Novartis Investigative Site

    RECRUITING

    Seoul, 05505, South Korea

  • Novartis Investigative Site

    RECRUITING

    Seoul, 06351, South Korea

  • Novartis Investigative Site

    RECRUITING

    Seoul, 06591, South Korea

  • Novartis Investigative Site

    RECRUITING

    Basel, 4058, Switzerland

  • Novartis Investigative Site

    RECRUITING

    Bern, 3010, Switzerland

  • Novartis Investigative Site

    RECRUITING

    Geneva, 1211, Switzerland

  • Novartis Investigative Site

    RECRUITING

    Genolier, 1272, Switzerland

  • Novartis Investigative Site

    RECRUITING

    Changhua, 50006, Taiwan

  • Novartis Investigative Site

    RECRUITING

    Kaohsiung City, 80756, Taiwan

  • Novartis Investigative Site

    RECRUITING

    Tainan, 704302, Taiwan

  • Novartis Investigative Site

    RECRUITING

    Taipei, 10002, Taiwan

  • Novartis Investigative Site

    RECRUITING

    Istanbul, Fatih, 34098, Turkey (Türkiye)

  • Novartis Investigative Site

    RECRUITING

    Ankara, Sihhiye-Altindag, 06230, Turkey (Türkiye)

  • Novartis Investigative Site

    RECRUITING

    Ankara, 06000, Turkey (Türkiye)

  • Novartis Investigative Site

    RECRUITING

    Izmir, 35060, Turkey (Türkiye)

  • Novartis Investigative Site

    RECRUITING

    Kocaeli, 41380, Turkey (Türkiye)

  • Novartis Investigative Site

    RECRUITING

    Samsun, 55200, Turkey (Türkiye)

  • Summit Medical Group Oncology

    RECRUITING

    Berkeley Heights, New Jersey, 07922, United States

  • The Anderson Family Cancer Institute

    RECRUITING

    Jupiter, Florida, 33458, United States

  • The Ohio State University Comprehensive Cancer Center

    RECRUITING

    Columbus, Ohio, 43221, United States

  • Winship Cancer Institute of Emory University

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Yale University School Of Medicine

    RECRUITING

    New Haven, Connecticut, 06520, United States

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