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New treatment option for Myelofibrosis (MF)
Official title A Study of Roginolisib in Combination With Ruxolitinib in Patients With Myelofibrosis (MF) Who Are Unresponsive to JAK Inhibitors
ClinicalTrials.gov ID: NCT06887803
What this study is testing
What is Roginolisib?
Roginolisib is an investigational medicine, being studied as a potential treatment for myelofibrosis (mf).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 8 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- ≥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
You likely can't join if
- 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...
- Active autoimmune process (e.g., rheumatoid arthritis, moderate or severe psoriasis, multiple sclerosis, inflammatory bowel disease, immune colitis)...
- History or presence of an abnormal ECG that, in the Investigator's opinion, is clinically meaningful. Screening QTc interval \> 480 milliseconds is...
- Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (\< 6 months prior to enrolment), myocardial...
- Patients with active malignancy requiring concurrent intervention or previous malignancies unless a complete remission was achieved at least 2 years...
See the full eligibility criteria
Who can 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...
- 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...
- 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...
- 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...
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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) \ 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...
- 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)...
- Presence of active or inactive 'latent' tuberculosis.
The study team makes the final eligibility decision.
Where it's taking place
- Florence, Florence, Italy
- Rozzano, Milan, Italy
- Bologna, Italy
- Meldola, Italy
- Udine, Italy
- Barcelona, Spain
- Madrid, Spain
- Salamanca, Spain
- Boston, Lincolnshire, United Kingdom
- Belfast, United Kingdom
- London, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 8 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Florence, Florence, Italy; Rozzano, Milan, Italy; Bologna, Italy; Meldola, Italy; Udine, Italy; Barcelona, Spain and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.