Actively Recruiting
A Study of Roginolisib in Combination With Ruxolitinib in Patients With Myelofibrosis (MF) Who Are Unresponsive to JAK Inhibitors
Led by iOnctura · Updated on 2026-04-27
26
Participants Needed
11
Research Sites
136 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Roginolisib in Combination With Ruxolitinib in Patients With Myelofibrosis (MF) Who Are Unresponsive to JAK Inhibitors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the time of signing informed consent
- Able to give signed informed consent and comply with protocol requirements
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Diagnosis of Myelofibrosis, Post-Polycythaemia Vera MF, or Post-Essential Thrombocythemia MF
- Dynamic International Prognostic Scoring System (DIPSS) risk category of intermediate-1, intermediate-2, or high
- Treated with ruxolitinib for at least 3 months with stable dose of 10 mg or more for at least 8 weeks before Day 1, with less than 25% spleen reduction and spleen palpable at least 10 cm below left costal margin
- No experimental or effective MF drug therapy (except ruxolitinib) within 3 months before study drug start, except if completed 6 months prior to ruxolitinib
- Active MF symptoms with Total Symptom Score of 10 or higher at screening
- Peripheral blast count less than 10%
- Women of non-childbearing potential or women with negative pregnancy test who agree to use highly effective contraception
- Men who agree to use highly effective contraception
You will not qualify if you...
- Unable to swallow or any upper gastrointestinal condition preventing oral medications
- History of Grade 3 or 4 adverse events unresponsive to therapy or unresolved except fatigue; Grade 2 or less neuropathy or alopecia allowed
- Active autoimmune diseases requiring systemic treatment
- Abnormal ECGs clinically significant or prolonged QTc interval over 480 ms (with specific exceptions)
- Active significant cardiovascular disease within 6 months
- Active malignancy requiring treatment or recent malignancy without at least 2 years remission
- Serious or uncontrolled medical disorders or active infection increasing risk or impairing treatment
- Use of erythropoiesis stimulating agents within 4 weeks prior to roginolisib
- Splenic irradiation within 3 months prior to roginolisib
- Major surgery within 2 weeks before first dose (minor procedures allowed)
- Immune-suppressive treatment including corticosteroids over 10 mg/day prednisone equivalent within 14 days prior to first dose
- Live vaccine within 30 days before starting study therapy
- Known allergy to study drugs or components
- Currently breastfeeding
- Known alcohol or substance abuse
- Laboratory or medical history parameters outside protocol-defined ranges including low neutrophils, platelets, hemoglobin, impaired kidney or liver function, coagulopathy, or active infections including hepatitis B, C, HIV
- Active or latent tuberculosis present
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 11 locations
1
Azienda Ospedaliero Universitaria Careggi Firenze, Struttura Complessa di Ematologia
Florence, Florence, Italy, 50134
Actively Recruiting
2
IRCCS Clinical Institute Humanitas
Rozzano, Milan, Italy, 20089
Actively Recruiting
3
Istituto di Ematolgia e Oncologia Medica
Bologna, Italy, 40138
Actively Recruiting
4
Azienda Sanitario Universitaria Friuli Centrale
Udine, Italy, 33100
Actively Recruiting
5
Vall d'Hebron University Hospital
Barcelona, Spain, 08035
Actively Recruiting
6
Avigunda Gran via de l'Hospitalet 199-203, 08908 L'Hospitalet de Llobregat
Barcelona, Spain, 08908
Actively Recruiting
7
START Madrid CIOCC
Madrid, Spain, 28050
Not Yet Recruiting
8
Hospital Universitario de Salamanca
Salamanca, Spain, 37007
Actively Recruiting
9
United Lincolnshire Teach Hospitals NHS Trust, Pilgrim Hospital Boston
Boston, Lincolnshire, United Kingdom, PE21 9QS
Not Yet Recruiting
10
Belfast City Hospital
Belfast, United Kingdom, BT9&AB
Not Yet Recruiting
11
Guy´s and St. Thomas NHS Foundation Trust
London, United Kingdom, SE1 9RT
Not Yet Recruiting
Research Team
T
Tracey Hammett, RN
CONTACT
K
Karen Tonge
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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