Ignite Creation Date:
2025-12-24 @ 7:39 PM
Ignite Modification Date:
2026-01-01 @ 7:41 AM
Study NCT ID:
NCT06887803
Status:
RECRUITING
Last Update Posted:
2025-11-24
First Post:
2025-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Roginolisib in Combination With Ruxolitinib in Patients With Myelofibrosis (MF) Who Are Unresponsive to JAK Inhibitors
Sponsor:
iOnctura
Organization:
Study Overview
Official Title:
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 JAK Inhibitors (HEMA-MED)
Status:
RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HEMA-MED
Brief 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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2024-515252-20 | EUDRACT_NUMBER | None | View |