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New treatment option for Myelofibrosis
Official title RVU120 in Patients With Intermediate or High-risk, Primary or Secondary Myelofibrosis
ClinicalTrials.gov ID: NCT06397313
What this study is testing
What is RVU120?
RVU120 is an investigational medicine, being studied as a potential treatment for myelofibrosis.
Also referred to as SEL120.
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 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.
- Phase 2: a mid-size study of how well it works
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
- 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...
- Measurable splenomegaly as demonstrated by palpable spleen measuring ≥5 cm below the left costal margin. The edge of the spleen should be measured...
You likely can't join if
- Each participant must not meet any of the following:
- 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.
- Active known second malignancy with the exception of any of the following:
- Adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or in situ cervical cancer
See the full eligibility criteria
- 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...
- Measurable splenomegaly as demonstrated by palpable spleen measuring ≥5 cm below the left costal margin. The edge of the spleen should be measured from the mid-clavicular line on the left side of the abdomen to the...
- Active symptoms of MF as demonstrated by a symptom score of at least 5 points (on a 0 to 10 scale) on at least one of the symptoms or a score of 3 or greater on at least 2 of the following symptoms: night sweats...
- Eastern Cooperative Oncology Group (ECOG) performance score 0-2.
- Adequate hematologic function defined as:
- absolute neutrophil count (ANC) ≥1.0 × 109/L (without growth factor support)
- platelet count ≥50 × 109/L (Cohort 2 and Cohort 3 only)
- Adequate renal function defined as calculated or measured creatinine clearance (CrCl) of ≥30 mL/minute using the formula of Cockcroft and Gault (see Section 15).
- Adequate liver function defined as (a) aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3 × upper limit of normal (ULN); (b) alkaline phosphatase (ALP) ≤2 × ULN (ALP ≤5 × ULN for participants with...
- Each participant must not meet any of the following:
- 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.
- Active known second malignancy with the exception of any of the following:
- Adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or in situ cervical cancer
- Adequately treated Stage I cancer from which the participant is currently in remission and has been in remission for ≥2 years
- Low-risk prostate cancer with a Gleason score \<7 and a prostate-specific antigen (PSA) level \<10 ng/mL
- Any other cancer from which the participant has been disease-free for ≥3 years.
- Known or suspected allergy to RVU120 or RUX.
- Impairment of gastrointestinal function or gastrointestinal disease
- Major surgical procedure or significant traumatic injury within 28 days Placement of a vascular access device or minor surgery is permitted within 14 days before Cycle 1 Day 1 (provided that the wound has healed).
- Ongoing systemic infection requiring antibiotic, antiviral, or antifungal treatment. Note: prophylactic treatment is allowed.
- Significant cardiac dysfunction defined as myocardial infarction within 12 months of Cycle 1 Day 1, New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled dysrhythmias, poorly controlled angina...
- Taking any medications, herbal supplements, or other substances (including smoking) that are known to be strong inhibitors or moderate/strong inducers or sensitive substrates of CYP1A2, within less than 5 half-lives...
- History of ventricular arrhythmia, or QTc ≥470 millisecond (Bazett's formula).
- Known active human immunodeficiency virus (HIV) infection
- Current active liver disease from any cause
- Pregnant or lactating females.
- Any other prior or current medical or psychiatric condition, intercurrent illness, surgical history, physical or electrocardiogram (ECG) findings, laboratory abnormalities, or extenuating circumstance (e.g., alcohol or...
The study team makes the final eligibility decision.
Where it's taking place
- Bologna, Italy
- Brescia, Italy
- Catania, Italy
- Meldola, Italy
- Milan, Italy
- Biała Podlaska, Poland
- Bydgoszcz, Poland
- Chorzów, Poland
- Gdansk, Poland
- Katowice, Poland
- Kielce, Poland
- Krakow, Poland
- Lublin, Poland
- Torun, Poland
- Warsaw, Poland
- Wroclaw, Poland
- Zielona Góra, Poland
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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to 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 Bologna, Italy; Brescia, Italy; Catania, Italy; Meldola, Italy; Milan, Italy; Biała Podlaska, Poland and 11 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.