RecruitingPhase 1Phase 2NCT06887803

A Study of Roginolisib in Combination With Ruxolitinib in Patients With Myelofibrosis (MF) Who Are Unresponsive to JAK Inhibitors

A Phase I/II Open-Label, Multi-centre Study to Assess the Safety and Tolerability of Roginolisib in Combination With Ruxolitinib in Patients With Myelofibrosis (MF) Who Are Unresponsive to an Approved JAK Inhibitors (HEMA-MED)

Sponsor

iOnctura

Enrollment

26 participants

Start Date

Nov 17, 2025

Study Type

INTERVENTIONAL

Conditions

Myelofibrosis (MF)

Summary

The goal of this clinical trial is to learn how roginolisib works in comparison to standard treatment in adult patients with Myelofibrosis. The main questions it aims to answer is to evaluate the safety and tolerability of roginolisib when administered in combination with ruxolitinib.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Roginolisib for people with myelofibrosis (mf). The study is currently recruiting participants at 12 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGRoginolisib

IOA-244: 80 mg (corresponding to 72 mg roginolisib) Ruxolitinib: up to 25 mg BD

Locations(12)

Azienda Ospedaliero Universitaria Careggi Firenze, Struttura Complessa di Ematologia

Florence, Florence, Italy

IRCCS Clinical Institute Humanitas

Rozzano, Milan, Italy

Istituto di Ematolgia e Oncologia Medica

Bologna, Italy

Istituto Romagnolo per lo Studio dei Tumori

Meldola, Italy

Azienda Sanitario Universitaria Friuli Centrale

Udine, Italy

Vall d'Hebron University Hospital

Barcelona, Spain

Avigunda Gran via de l'Hospitalet 199-203, 08908 L'Hospitalet de Llobregat

Barcelona, Spain

START Madrid CIOCC

Madrid, Spain

Hospital Universitario de Salamanca

Salamanca, Spain

United Lincolnshire Teach Hospitals NHS Trust, Pilgrim Hospital Boston

Boston, Lincolnshire, United Kingdom

Belfast City Hospital

Belfast, United Kingdom

Guy´s and St. Thomas NHS Foundation Trust

London, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06887803

Related Trials

A Phase 1 Study of PRT12396 in Participants With Select Myeloproliferative Neoplasms

NCT074698918 locations

Pacritinib Effectiveness in Real-world Settings

NCT07774455

TACrolimus Targeted Immunosuppression Cessation in ALlogeneic HCT

NCT07302776

Pacritinib For Bone Marrow Fibrosis In Patients With Myelofibrosis Who Have Thrombocytopenia

NCT0739415313 locations

Phase I/II Clinical Trial of Axatilimab, a CSF1R Monoclonal Antibody, in Combination With Ruxolitinib as Therapy for Patients With Myelofibrosis (MF) and Chronic Myelomonocytic Leukemia (CMML)

NCT071283811 location