Blood and Lymph Conditions

All Conditions

Neoplasms

Heart and Blood Diseases

Rare Diseases

Anemia

Myeloproliferative Disorders

Polycythemia Vera

Polycythemia

Primary Myelofibrosis

Thrombocytosis

Thrombocythemia, Essential

Hematologic Diseases

Bone Marrow Diseases

Bone Marrow Neoplasms

Hematologic Neoplasms

Blood Platelet Disorders

Hemostatic Disorders

Blood Coagulation Disorders

Hemorrhagic Disorders

Chronic Myeloproliferative Disorders

Essential Thrombocythemia

In the Phase 1b (dose-escalation) portion of the study, DISC-0974 will be administered subcutaneously every 4 weeks.

In the Phase 2a (expansion) portion of the study, DISC-0974 will be administered subcutaneously every 4 weeks.

DISC-0974 is administered subcutaneously.

DISC-0974

Disc Medicine Clinical Trials

Tiffany Brown

James Foran, MD

Linda Kemp

Moshe Talpaz, MD

Ashya Burgress

Naseema Gangat, MBBS

Nicole Gaudin

Amy Zhou, MD

Jack Martin

Michelle Gianvito

Prioty Islam, MD, MSc

Libyadda Mosley

Anne Wofford, MD

Joe Lucchese

Aaron Gerds, MD

Colin Hammons

Keshara Bandara

Ronan Swords, MD, PhD

Thomas Greenwood

Elizabeth Hexner, MD

Romany Gergis

Prithviraj Bose, MD

Kayla Pankey

Anna Halpern, MD

Kristin Komnick

Laura Michaelis, MD

Will Savage, MD PhD

This phase 1b/2a open-label study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of DISC-0974 as well as categorize the effects on anemia response in subjects with myelofibrosis and anemia.

Study of DISC-0974 in Participants With Myelofibrosis and Anemia

A Phase 1b/2a Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DISC-0974 in Participants With Myelofibrosis and Anemia

Disc Medicine, Inc

This will be a phase 1 study with a traditional "3+3" design of combination ruxolitinib (at fixed doses of 10mg BID or 15mg BID) and abemaciclib. There are 3 planned dose levels of abemaciclib: 50, 100 and 150 mg. Cycles will be 4 weeks (28 days) long and DLT window will consist of first cycle.

Ruxolitinib

Abemaciclib

Raajit Rampal, MD, PhD

Michael Mauro, MD

Raajit Rampal, MD,PhD

Raajit Rampa, MD, PhD

Raajit Rampal

The study is being done to see if the combination of ruxolitinib and abemaciclib is a safe and effective treatment for people with primary or post-polycythemia vera/essential thrombocythemia myelofibrosis.

This is a multicenter, non-randomized phase 1 clinical trial evaluating the safety and activity of combined ruxolitinib and abemaciclib in patients with primary or post-polycythemia vera/essential thrombocythemia myelofibrosis. Patients will be treated in dose escalation using a 3+3 design.

A Study of Ruxolitinib in Combination With Abemaciclib for the Treatment of Myelofibrosis

A Phase I Study of Ruxolitinib Plus Abemaciclib for Patients With Primary or Post-polycythemia Vera/Essential Thrombocythemia Myelofibrosis

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Dose-limiting toxicities (DLTs) will be defined based on toxicities observed during the first cycle of the combination treatment. Adverse events (AEs) that are possibly, probably or definitely related to study drug(s) will be scored as toxicities. Toxicities will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

Response assessment will be according to the 2013 International Working Group (IWG) criteria.

Eli Lilly and Company

Incyte Corporation

Memorial Sloan Kettering Cancer Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of DISC-0974 in Participants With Myelofibrosis and Anemia	NCT05320198	Myelofibrosis; ... Anemia Myelofibrosis Myelofibrosis D... Primary Myelofi... Post-essential ...	DISC-0974	18 Years -	Disc Medicine, Inc
A Study of Ruxolitinib in Combination With Abemaciclib for the Treatment of Myelofibrosis	NCT05714072	Myelofibrosis D...	Ruxolitinib Abemaciclib	18 Years -	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for myelofibrosis due to and following polycythemia vera