Study of DISC-0974 (RALLY-MF) in Participants With Myelofibrosis or Myelodysplastic Syndrome and Anemia

ConditionsMyelofibrosis; Anemia Anemia Myelofibrosis Myelofibrosis Due to and Following Polycythemia Vera Primary Myelofibrosis Post-essential Thrombocythemia Myelofibrosis Myelodysplastic Syndromes

Trial statusRecruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorDisc Medicine, Inc

About this trial

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 or myelodysplastic syndrome and anemia.

Eligibility criteria

Qualifiers

Age 18 years or older at the time of signing the informed consent form (ICF).

For Phase 1b: DIPSS score of 3 to 4 (intermediate 2 risk) or ≥5 (high-risk) primary MF, post PV MF, and/or post ET MF, as confirmed in the most recent local bone marrow biopsy report, according to WHO 2016 criteria.55

Androgens

EPO

Disqualifiers

Hereditary hemochromatosis

Hemoglobinopathy or intrinsic RBC defect associated with anemia

Total splenectomy

Hematopoietic cell transplant within the past 2 years or graft vs host disease requiring immunosuppression

Trial design

Treatments tested in this trial

DISC-0974

Treatment groups

150 Participants

are divided into 2 treatment groups

Locations

Australia

Linear Clinical Research6009, Nedlands Australia

St. Vincent's Hospital2010, Sydney Australia

Perth Blood Institute6005, West Perth Australia

United States

California

City of Hope - Duarte91010, Duarte United States

Sponsors and collaborators

Disc Medicine, Inc

Lead sponsor

Source ClinicalTrials.gov