RVU120 in Patients With Intermediate or High-risk, Primary or Secondary Myelofibrosis
ConditionMyelofibrosis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRyvu Therapeutics SA
About this trial
The objective of this clinical trial is to evaluate the efficacy (how well the drug works), safety, pharmacokinetics (PK), and pharmacodynamics (PD) of the study drug, RVU120, in treating adult patients with intermediate or high-risk, primary or secondary myelofibrosis. RVU120 will be given as a single agent or in combination with ruxolitinib.
Eligibility criteria
Qualifiers
Age ≥18 years
Diagnosis of Primary or Secondary myelofibrosis (MF) according to the revised World Health Organization (WHO) criteria (Arber 2022).
Intermediate or high-risk disease.
Resistant or refractory to prior Janus kinase (JAK) inhibitor treatment or ineligible for JAK inhibitor treatment in the opinion of the investigator; or Suboptimal response to JAK inhibitor treatment. Note: a suboptimal response to JAK inhibitor treatment is defined as spleen size increase by palpation >25% after the first 3 months of treatment with a JAK inhibitor or persistent splenomegaly (spleen volume of >450 cm3) after at least 6 months of JAK inhibitor treatment and presence of 1 symptom score ≥5 or 2 symptom scores ≥3, new or persistent red blood cell (RBC) transfusion dependence; or may include participants naïve to previous treatment with JAK inhibitor.
Disqualifiers
Peripheral blood blast count of ≥10% or bone marrow blast count of ≥10%.
Prior history of hematopoietic stem cell transplant.
Participation in any other study in which receipt of an investigational new drug occurred within 4 weeks prior to Cycle 1 Day 1.
Adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or in situ cervical cancer
Trial design
Treatments tested in this trial
- RVU120
- Ruxolitinib
Treatment groups
230 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov