A Study of Roginolisib in Combination With Ruxolitinib in Patients With Myelofibrosis (MF) Who Are Unresponsive to JAK Inhibitors (HEMA-MED)
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
A observational or N/A phase clinical study on Myelofibrosis (MF), this trial is actively recruiting participants. The trial is conducted by iOnctura and has accumulated 6 data snapshots since 2025. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.
Study Description(click to expand)A Phase I/II Open-Label, Single Arm Multi-centre Study to Assess the Safety and Tolerability of Roginolisib in Combination with Ruxolitinib in Patients with Myelofibrosis (MF) who are Unresponsive to JAK inhibitors (HEMA-MED).
This study will enrol approximately 26 male and female patients aged over 18 years with MF, who have been treated with ruxolitinib for ≥ 3 months with a stable dose ≥ 10 mg for at least the last 8 weeks prior to Day 1 and no significant spleen reduction.
The study will initially enrol 13 patients in Part 1 to assess the benefit/risk profile of roginolisib when combined with ruxolitinib. Part 2 will enrol an additional 13 patients to further characterize the benefit/risk.
A Phase I/II Open-Label, Single Arm Multi-centre Study to Assess the Safety and Tolerability of Roginolisib in Combination with Ruxolitinib in Patients with Myelofibrosis (MF) who are Unresponsive to JAK inhibitors (HEMA-MED).
This study will enrol approximately 26 male and female patients aged over 18 years with MF, who have been treated with ruxolitinib for ≥ 3 months with a stable dose ≥ 10 mg for at least the last 8 weeks prior to Day 1 and no significant spleen reduction.
The study will initially enrol 13 patients in Part 1 to assess the benefit/risk profile of roginolisib when combined with ruxolitinib. Part 2 will enrol an additional 13 patients to further characterize the benefit/risk.
Status Flow
Change History
6 versions recorded-
Apr 28, 2026 — Present [daily]
Recruiting
Phase: PHASE1/PHASE2 → None
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Feb 2026 — Apr 2026 [monthly]
Recruiting PHASE1/PHASE2
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Dec 2025 — Feb 2026 [monthly]
Recruiting PHASE1/PHASE2
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Sep 2025 — Dec 2025 [monthly]
Recruiting PHASE1/PHASE2
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May 2025 — Sep 2025 [monthly]
Recruiting PHASE1/PHASE2
Status: Not Yet Recruiting → Recruiting
▶ Show 1 earlier version
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Apr 2025 — May 2025 [monthly]
Not Yet Recruiting PHASE1/PHASE2
First recorded
Eligibility 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.
Contact Information
- iOnctura
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
Barcelona, Spain , Barcelona, Spain , Belfast, United Kingdom , Bologna, Italy , Boston, United Kingdom , Florence, Italy , London, United Kingdom , Madrid, Spain , Rozzano, Italy , Salamanca, Spain and 1 more location