Myelofibrosis (MF)Phase 1/2HEMA-MEDNCT06887803
A Study of Roginolisib in Combination With Ruxolitinib in Patients With Myelofibrosis (MF) Who Are Unresponsive to JAK Inhibitors
A Phase 1/2 study testing Roginolisib in people with Myelofibrosis (MF), run by iOnctura at 12 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelofibrosis (MF)
- What is being tested?
- Roginolisib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 12 sitesin 3 countries
- Study dates
- 17 Nov 2025to Jul 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years of age inclusive, at the time of signing the informed consent.
- Capable of giving signed informed consent, which includes compliance with the requirements of this protocol.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Diagnosis of MF, Post-Polycythaemia Vera Myelofibrosis MF (PPV-MF), or post-essential thrombocythemia MF (PET-MF)
- Dynamic International Prognostic Scoring System (DIPSS) risk category of intermediate-1, intermediate-2, or high
- Treated with ruxolitinib for ≥ 3 months with a stable dose ≥ 10 mg for a minimum of 8 weeks prior to Day 1. Furthermore, patients must show an unsatisfactory spleen reduction, such as a reduction of less than 25%, and spleen must be palpable ≥ 10 cm below the left costal margin on physical examination
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- Did not receive experimental drug therapy for MF or any other drug considered as an effective treatment for MF (e.g., danazol, hydroxyurea, interferon products) with the exception of ruxolitinib, within 3 months of starting study drug (except in conditions where other effective treatments for MF were completed 6 months prior to starting ruxolitinib)
- Independent of spleen size, active symptoms of MF at the screening visit, as demonstrated by the presence of a Total Symptom Score (TSS) of ≥ 10 using the Screening Symptom Form.
- Peripheral blast count < 10%
- Act to avoid pregnancy or fathering children based on the criteria below:
- Women of non-childbearing potential (i.e., surgically sterile with a hysterectomy and/or bilateral oophorectomy OR ≥ 12 months of amenorrhea and at least 50 years of age).
- Women of childbearing potential who had a negative serum pregnancy test at screening and who agree to take appropriate precautions to avoid pregnancy (with at least 99% certainty) from screening through safety follow-up, at least 1 month after the last dose of study treatment. Permitted methods that are at least 99% effective in preventing pregnancy should be communicated to the patient and their understanding confirmed.
- Men who agree to take appropriate precautions to avoid fathering from screening through safety follow-up, at least 1 month after the last dose of study treatment. Permitted methods that are at least 99% effective in preventing pregnancy (see Appendix 3) should be communicated to the patient and their understanding confirmed.
Who cannot join
- Inability to swallow food or any condition of the upper gastrointestinal tract that precludes administration of oral medications.
- History of a prior Grade 3 or 4 AE which did not respond to therapy or resolved with treatment interruptions and returned to at least Grade 1, other than fatigue. Note: Patients with ≤ Grade 2 neuropathy or alopecia are an exception and may enrol.
- Active autoimmune process (e.g., rheumatoid arthritis, moderate or severe psoriasis, multiple sclerosis, inflammatory bowel disease, immune colitis) for which systemic treatment (i.e., use of disease-modifying agents, corticosteroids, or immunosuppressive drugs) is required. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- History or presence of an abnormal ECG that, in the Investigator's opinion, is clinically meaningful. Screening QTc interval > 480 milliseconds is excluded (corrected by Fridericia). In the event that a single QTc is > 480 milliseconds, the patient may enrol if the average QTc for the 3 ECGs is < 480 milliseconds. For patients with an intraventricular conduction delay (QRS interval > 120 msec), the JTc interval may be used in place of the QTc with Sponsor approval. The JTc must be < 340 milliseconds if JTc is used in place of the QTc. Patients with left bundle branch block are excluded.
- Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrolment), myocardial infarction (< 6 months prior to enrolment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication.
- Patients with active malignancy requiring concurrent intervention or previous malignancies unless a complete remission was achieved at least 2 years prior to study entry and no additional therapy is required during the study period and the patient is assessed at low risk of relapse by the investigator. Note: Patients with a slow progressing cancer (e.g. prostate) or an in situ cancers (e.g. cervical dysplasia) are permitted.
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- Any serious or uncontrolled medical disorder or active infection that, in the opinion of the Investigator, may increase the risk associated with study participation, study drug administration, or would impair the ability of the patient to receive protocol therapy.
- Use of the following treatments within the time periods noted:
- Erythropoiesis stimulating agent (ESA) within 4 weeks prior to start of roginolisib.
- Splenic irradiation within 3 months prior to start of roginolisib.
- Major surgery within 2 weeks of the first dose of study drug (minimally invasive procedures such as bronchoscopy, bone marrow biopsy, insertion of a central venous access device, and insertion of a feeding tube are not considered major surgery and are not exclusionary)
- Receiving an immune-suppressive based treatment for any reason (including chronic use of systemic corticosteroid at doses > 10 mg/day prednisone equivalent) within 14 days prior to the first dose of study treatment. Use of inhaled or topical steroids (including but not limited to creams or intra-articular injection) or brief corticosteroid use for radiographic procedures or systemic corticosteroids ≤ 10 mg is permitted.
- Have received a live vaccine within 30 days of planned start of study therapy while on trial. Other type of vaccines, including SARS-Co2 vaccines, are allowed.
- Known allergy or reaction to any component of either study drugs or formulation components.
- Currently breastfeeding.
- Known alcohol or other substance abuse.
- Laboratory and medical history parameters not within Protocol-defined range.
- Absolute neutrophil count < 1.5 × 109/L.
- Platelet count < 100 × 109/L.
- Haemoglobin < 8 g/dL (transfusion is acceptable to meet this criterion).
- Serum creatinine ≥ 1.5 × institutional ULN or measured or calculated creatinine clearance (glomerular filtration rate can also be used in place of creatinine or CrCl) < 50 mL/min for patients with creatinine levels > 1.5 × institutional ULN.
- Aspartate aminotransferase (AST) or Alanine transaminase (ALT) ≥ 2.5 × ULN in the absence of hepatic metastases or ≥ 5 × ULN with hepatic metastases at screening.
- Total bilirubin ≥ 1.2 × ULN are excluded unless direct bilirubin is ≤ ULN. If there is no institutional ULN, then direct bilirubin must be < 40% of total bilirubin to be eligible (except patients with Gilbert syndrome, who must have total bilirubin < 51.3 μmol/L).
- International normalized ratio or prothrombin time (PT) > 1.5 × ULN.
- Activated partial thromboplastin time (aPTT) > 1.5 × ULN.
- Evidence of acute infection of hepatitis B virus (HBV), (for example: positive for HBsAg, anti-HBc, IgM anti-HBc and negative for anti-HBs), hepatitis C virus (HCV) (for example: HCV antibody reactive; HCV RNA detected) and HIV.
- Patients who are on stable antiviral therapy, in good clinical control (ie for HIV a viral load < 400 copies/mL and a CD4+ count of ≥ 350 cells/uL) AND asymptomatic are eligible for the study
- Presence of active or inactive 'latent' tuberculosis.
Trial locations and contacts
12 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
12 sites in 3 countries
Italy5 sites, 5 recruiting
- Recruiting
Istituto di Ematolgia e Oncologia Medica
Bologna, 40138
Francesca Palandri, Prof, +39512143044, francesca.palandri@unibo.it
Francesca Palandri, Prof
- Recruiting
Azienda Ospedaliero Universitaria Careggi Firenze, Struttura Complessa di Ematologia
Florence, Florence, 50134
Alessandro Vannucchi, Prof, 0557947824 or : 0557947276, a.vannucchi@unifi.it
Alessandro Vannucchi, Prof
- Recruiting
Istituto Romagnolo per lo Studio dei Tumori
Meldola, 47014
Alessandro Lucchesi, MD, 0039.0543.739292, alessandro.lucchesi@irst.emr.it
Alessandro Lucchesi
- Recruiting
IRCCS Clinical Institute Humanitas
Rozzano, Milan, 20089
Armando Santoro, Prof, +39 0282244080, armando.santoro@cancercenter.humanitas.it
Armando Santoro, Prof
- Recruiting
Azienda Sanitario Universitaria Friuli Centrale
Udine, 33100
Mario Tiribelli, MD, +390342559662, mario.tiribelli@uniud.it
Mario Tiribelli, MD
Spain4 sites, 4 recruiting
- Recruiting
Vall d'Hebron University Hospital
Barcelona, 08035
Maria Laura Fox, MD, +34932746000 ext. 2347, mlfox@vhio.net
Maria Laura Fox, MD
- Recruiting
Avigunda Gran via de l'Hospitalet 199-203, 08908 L'Hospitalet de Llobregat
Barcelona, 08908
Jasson Andrés Villareal Hernández, Dr, +34 93 260 70 68, jvillarreal@iconcologia.net
Jasson Andrés Villareal Hernández, Dr
- Recruiting
START Madrid CIOCC
Madrid, 28050
Damian Cubillas, MD, damian.cubillas@startmadrid.com
- Recruiting
Hospital Universitario de Salamanca
Salamanca, 37007
Jesus Maria Hernandez Riva, MD, +34 9232911000 ext. 56606, jmhr@usal.es
Jesus Maria Hernandez Rivas, MD
United Kingdom3 sites, 3 recruiting
- Recruiting
Belfast City Hospital
Belfast, BT9&AB
Graeme Greenfield, MD, Graeme.Greenfield@belfasttrust.hscni.net
- Recruiting
United Lincolnshire Teach Hospitals NHS Trust, Pilgrim Hospital Boston
Boston, Lincolnshire, PE21 9QS
Ciro Rinaldi, Prof, crinaldi@nhs.net
- Not yet recruiting
Guy´s and St. Thomas NHS Foundation Trust
London, SE1 9RT
Priya Sriskandarajah, MD, priya.sriskandarajah@nhs.net
About this study
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 an Approved JAK Inhibitors (HEMA-MED)
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.
Read the 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.
- Conditions
- Myelofibrosis (MF)
- Being tested
- Roginolisib
- Keywords
- Myelofibrosis
- Medical subject headings
- Primary Myelofibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RoginolisibDrug
IOA-244: 80 mg (corresponding to 72 mg roginolisib) Ruxolitinib: up to 25 mg BD
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Roginolisib and ruxolitinib Receives: Drug: Roginolisib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment emergent adverse events
Safety measure by Adverse Event's
Measured: Day 1 and 15 of cycle 1; Day 1 of each subsequent cycle whilst on treatment anticipated to be 52 weeks. Cycle length 28 days
Number of Participants with abnormal ECG recordings
Changes observed on 12-lead ECG
Measured: Day 1 of each cycle whilst on treatment anticipated to be 52 weeks. Cycle length 28 days
Number of participants with abnormal laboratory parameters
Standard laboratory parameters (including clinical chemistry, heamatology)
Measured: Day 1 and 15 of cycle 1; Day 1 of each subsequent cycle whilst on treatment anticipated to be 52 weeks. Cycle length 28 days
Number of participants with changes in blood pressure measurements
As measured by blood pressure measurements
Measured: Day 1 and 15 of cycle 1; Day 1 of each subsequent cycle whilst on treatment anticipated to be 52 weeks. Cycle length 28 days
Secondary outcomes (6)
To evaluate biomarker responses (e.g., Treg reduction) when roginolisib is administered in combination with ruxolitinib in patients with MF.
Changes in peripheral blood Tregs from baseline at Week 12 and continued reduction over time
Measured: Day 1 of Cycle 1, 2 and 3 and then Day 1 of every other cycle (C5, C7 etc) until end of treatment anticipated to be 52 weeks. Cycle length is 28 days
Spleen reduction responses of roginolisib when administered in combination with ruxolitinib in patients with MF.
Splenic response rate (SRR) of ≥15%, ≥25% and ≥35% reduction in spleen volume as assessed by MRI/CT
Duration of spleen response
Measured: Splenic response rate at baseline, 12 and 24 weeks. Duration of spleen response every 12 weeks whilst on treatment anticipated to be 52 weeks.
To evaluate preliminary signs of clinical efficacy of roginolisib when given in combination with ruxolitinib
Proportion of patients with transfusion independence at 12 and 24 weeks where applicable
Measured: Patients will be followed up for overall survival every 12 weeks, for 96 weeks from last patient enrolled, until their death or end of the study
To determine the improvements of MF related symptoms when roginolisib is given in combination with ruxolitinib as assessed by the Myelofibrosis Symptom Assessment Form (MFSAF)
Proportion of patients who have any reduction in Total Symptom Score (TSS) at 12 and 24 weeks compared to baseline as measured by Myelofibrosis Symptom Assessment Form (MFSAF) Proportion of patients who have a reduction of ≥25% and ≥50% in TSS as measured by Myelofibrosis Symptom Assessment Form (MFSAF) Mean change in TSS as measured by Myelofibrosis Symptom Assessment Form (MFSAF) Time to the first ≥50% reduction compared to baseline in TSS as measured by Myelofibrosis Symptom Assessment Form (MFSAF) Duration of TSS response as measured by MFSAF (e.g., duration of TSS ≥25% and ≥50%)
Measured: TTS and MFSAF measured at baseline and at 12 and 24 weeks.
To determine the pharmacokinetic (PK) parameters of roginolisib when given in combination with ruxolitinib to allow exposure/response and/or exposure/safety assessment
Concentration of roginolisib at pre-dose and steady state levels Area under the curve [AUC]
Measured: Day 1 of each cycle whilst on treatment anticipated to be 52 weeks. Cycle length 28 days
To evaluate preliminary signs of clinical efficacy of roginolisib when given in combination with ruxolitinib
Overall Survival (OS) defined as the time from the date of the first dose of study treatment until death from any cause anticipated
Measured: Patients will be followed up for overall survival every 12 weeks, for 96 weeks from last patient enrolled, until their death or end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start17 Nov 2025
- Primary completionMar 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelofibrosis (MF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Arm, open-label
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- iOnctura
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Lahn, Dr, Study director, iOnctura
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06887803
- Sponsor's protocol ID
- IOA-244-203
- Other IDs
- 2024-515252-20
- Acronym
- HEMA-MED
- Status last verified
- Jun 2026
- First submitted
- 26 Feb 2025
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 an Approved JAK Inhibitors (HEMA-MED)
- ClinicalTrials.gov ID
- NCT06887803
- Acronym / sponsor ID
- HEMA-MED / IOA-244-203
- Conditions
- Myelofibrosis (MF)
- Keywords
- Myelofibrosis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- iOncturaIndustry (pharma, biotech, devices)
- Study start
- 17 Nov 2025 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 20 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Arm, open-label
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: RoginolisibRoginolisib and ruxolitinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- ≥18 years of age inclusive, at the time of signing the informed consent.
- Capable of giving signed informed consent, which includes compliance with the requirements of this protocol.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Diagnosis of MF, Post-Polycythaemia Vera Myelofibrosis MF (PPV-MF), or post-essential thrombocythemia MF (PET-MF)
- Dynamic International Prognostic Scoring System (DIPSS) risk category of intermediate-1, intermediate-2, or high
Key exclusion criteria (28 listed)
- Inability to swallow food or any condition of the upper gastrointestinal tract that precludes administration of oral medications.
- History of a prior Grade 3 or 4 AE which did not respond to therapy or resolved with treatment interruptions and returned to at least Grade 1, other than fatigue. Note: Patients with ≤ Grade 2 neuropathy or alopecia are an exception and may enrol.
- Active autoimmune process (e.g., rheumatoid arthritis, moderate or severe psoriasis, multiple sclerosis, inflammatory bowel disease, immune colitis) for which systemic treatment (i.e., use of disease-modifying agents, corticosteroids, or immunosuppressive drugs) is required. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- History or presence of an abnormal ECG that, in the Investigator's opinion, is clinically meaningful. Screening QTc interval > 480 milliseconds is excluded (corrected by Fridericia). In the event that a single QTc is > 480 milliseconds, the patient may enrol if the average QTc for the 3 ECGs is < 480 milliseconds. For patients with an intraventricular conduction delay (QRS interval > 120 msec), the JTc interval may be used in place of the QTc with Sponsor approval. The JTc must be < 340 milliseconds if JTc is used in place of the QTc. Patients with left bundle branch block are excluded.
- Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrolment), myocardial infarction (< 6 months prior to enrolment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RoginolisibIOA-244: 80 mg (corresponding to 72 mg roginolisib) Ruxolitinib: up to 25 mg BD | Drug | Single Arm |
Primary outcome
Number of participants with treatment emergent adverse events
Time frame: Day 1 and 15 of cycle 1; Day 1 of each subsequent cycle whilst on treatment anticipated to be 52 weeks. Cycle length 28 days
Safety measure by Adverse Event's
Number of Participants with abnormal ECG recordings
Time frame: Day 1 of each cycle whilst on treatment anticipated to be 52 weeks. Cycle length 28 days
Changes observed on 12-lead ECG
Number of participants with abnormal laboratory parameters
Time frame: Day 1 and 15 of cycle 1; Day 1 of each subsequent cycle whilst on treatment anticipated to be 52 weeks. Cycle length 28 days
Standard laboratory parameters (including clinical chemistry, heamatology)
Number of participants with changes in blood pressure measurements
Time frame: Day 1 and 15 of cycle 1; Day 1 of each subsequent cycle whilst on treatment anticipated to be 52 weeks. Cycle length 28 days
As measured by blood pressure measurements
6 secondary outcomes
To evaluate biomarker responses (e.g., Treg reduction) when roginolisib is administered in combination with ruxolitinib in patients with MF.
Time frame: Day 1 of Cycle 1, 2 and 3 and then Day 1 of every other cycle (C5, C7 etc) until end of treatment anticipated to be 52 weeks. Cycle length is 28 days
Spleen reduction responses of roginolisib when administered in combination with ruxolitinib in patients with MF.
Time frame: Splenic response rate at baseline, 12 and 24 weeks. Duration of spleen response every 12 weeks whilst on treatment anticipated to be 52 weeks.
To evaluate preliminary signs of clinical efficacy of roginolisib when given in combination with ruxolitinib
Time frame: Patients will be followed up for overall survival every 12 weeks, for 96 weeks from last patient enrolled, until their death or end of the study
To determine the improvements of MF related symptoms when roginolisib is given in combination with ruxolitinib as assessed by the Myelofibrosis Symptom Assessment Form (MFSAF)
Time frame: TTS and MFSAF measured at baseline and at 12 and 24 weeks.
To determine the pharmacokinetic (PK) parameters of roginolisib when given in combination with ruxolitinib to allow exposure/response and/or exposure/safety assessment
Time frame: Day 1 of each cycle whilst on treatment anticipated to be 52 weeks. Cycle length 28 days
To evaluate preliminary signs of clinical efficacy of roginolisib when given in combination with ruxolitinib
Time frame: Patients will be followed up for overall survival every 12 weeks, for 96 weeks from last patient enrolled, until their death or end of the study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Individual participant dataSharing planned: Undecided
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A Phase 1 Study of PRT12396 in Participants With Select Myeloproliferative Neoplasms
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Selinexor and Pacritinib in JAK Inhibitor-naïve MF Patients With Cytopenias
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Lahn, Dr study director
iOnctura
12 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Roginolisib in people with Myelofibrosis (MF), run by iOnctura at 12 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Italy, Spain, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tracey Hammett, RN (+44 7776498978, t.hammett@ionctura.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment emergent adverse events (time frame: Day 1 and 15 of cycle 1; Day 1 of each subsequent cycle whilst on treatment anticipated to be 52 weeks. Cycle length 28 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.