Actively Recruiting
RVU120 in Patients With Intermediate or High-risk, Primary or Secondary Myelofibrosis
Led by Ryvu Therapeutics SA · Updated on 2025-09-23
230
Participants Needed
18
Research Sites
158 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
RVU120 in Patients With Intermediate or High-risk, Primary or Secondary Myelofibrosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis of primary or secondary myelofibrosis according to WHO criteria
- Intermediate or high-risk myelofibrosis
- Resistant, refractory, or suboptimal response to prior JAK inhibitor treatment or ineligible for JAK inhibitor treatment
- Measurable splenomegaly with spleen palpable at least 5 cm below left costal margin or spleen volume ≥450 cm3 by MRI or CT
- Active myelofibrosis symptoms with a symptom score of at least 5 on one symptom or 3 or greater on two symptoms
- ECOG performance status of 0 to 2
- Adequate hematologic function with absolute neutrophil count ≥1.0 × 10^9/L (without growth factor support)
- Platelet count ≥50 × 10^9/L for Cohort 2 and Cohort 3 only
- Adequate renal function with creatinine clearance ≥30 mL/min
- Adequate liver function with AST and ALT ≤3 × upper limit of normal, ALP ≤2 × upper limit of normal (≤5 × for bone isozyme), and bilirubin <2 × upper limit normal or ≤3 × if due to Gilbert's disease
You will not qualify if you...
- Peripheral blood or bone marrow blast count ≥10%
- Prior hematopoietic stem cell transplant
- Participation in another investigational drug study within 4 weeks prior to Cycle 1 Day 1
- Active second malignancy except treated basal or squamous cell carcinoma, in situ cervical cancer, Stage I cancer in remission ≥2 years, low-risk prostate cancer (Gleason <7, PSA <10 ng/mL), or other cancer disease-free ≥3 years
- Known or suspected allergy to RVU120 or ruxolitinib
- Gastrointestinal impairment or disease
- Major surgery or significant injury within 28 days (vascular access or minor surgery allowed if healed)
- Ongoing systemic infection requiring treatment (prophylactic allowed)
- Significant cardiac dysfunction including recent myocardial infarction, advanced heart failure, uncontrolled dysrhythmias, poorly controlled angina, or left ventricular ejection fraction <40%
- Use of certain medications or substances affecting CYP1A2 within 5 half-lives before Cycle 1 Day 1
- History of ventricular arrhythmia or QTc ≥470 ms
- Known active HIV infection
- Current active liver disease
- Pregnant or lactating females
- Any other medical, psychiatric, or physical condition that may jeopardize safety or study objectives
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 18 locations
1
Policlinico Sant'Orsola-Malpighi
Bologna, Italy
Actively Recruiting
2
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Brescia, Italy
Actively Recruiting
3
Azienda Ospedaliero Universitaria Policlinico "G. Rodolico - San Marco"
Catania, Italy
Actively Recruiting
4
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l.
Meldola, Italy
Actively Recruiting
5
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, Italy
Actively Recruiting
6
Wojewódzki Szpital Specjalistyczny w Białej Podlaskiej
Biała Podlaska, Poland
Actively Recruiting
7
Szpital Uniwersytecki nr 2 im. dr Jana Biziela
Bydgoszcz, Poland
Actively Recruiting
8
M2M Med. Sp. z o.o. Sp. j.
Chorzów, Poland
Actively Recruiting
9
Centrum Wsparcia Badań Klinicznych UCK Ośrodek Badań Klinicznych Wczesnych Faz
Gdansk, Poland
Actively Recruiting
10
Pratia Hematologia Sp. z o.o.
Katowice, Poland
Actively Recruiting
11
Świętokrzyskie Centrum Onkologii Samodzielny Publiczny Zakład Opieki Zdrowotnej
Kielce, Poland
Completed
12
Samodzielny Publiczny Zakład Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie
Krakow, Poland
Actively Recruiting
13
Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie
Lublin, Poland
Actively Recruiting
14
Wojewódzki Szpital Zespolony im. L. Rydygiera w Toruniu
Torun, Poland
Actively Recruiting
15
Lux Med Onkologia Sp. z o.o.
Warsaw, Poland
Actively Recruiting
16
Wojskowy Instytut Medyczny Państwowy Instytut Badawczy
Warsaw, Poland
Actively Recruiting
17
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
Wroclaw, Poland
Actively Recruiting
18
Szpital Uniwersytecki Imienia Karola Marcinkowskiego w Zielonej Gorze Sp. z o. o.
Zielona Góra, Poland
Completed
Research Team
H
Head of Clinical Operations
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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