Actively Recruiting
Safety and Efficacy of RVU120 Combined With Venetoclax for Treatment of Relapsed/Refractory AML
Led by Ryvu Therapeutics SA · Updated on 2025-04-13
98
Participants Needed
37
Research Sites
138 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this study is to assess the safety, tolerability, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of RVU120 when administered in combination with venetoclax to adult patients with acute myeloid leukemia (AML) who are relapsed or refractory to prior therapy with venetoclax and a hypomethylating agent. The study consists of three parts. Part 1 aims to identify the doses of RVU120 and venetoclax that are considered to be safe and tolerated. Part 2 will assess the safety and efficacy of the doses selected. And Part 3 is a confirmatory cohort where patients will be treated at the same doses assessed in Part 2
CONDITIONS
Official Title
Safety and Efficacy of RVU120 Combined With Venetoclax for Treatment of Relapsed/Refractory AML
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of acute myeloid leukemia (AML) according to 2022 WHO classification
- Relapsed or refractory AML based on ELN 2022 criteria
- Previous failure of first-line treatment with venetoclax plus a hypomethylating agent
- No other therapeutic options likely to provide clinical benefit
- ECOG performance status between 0 and 2
- Adequate organ function including WBC count below 25 x 10^9/L, platelet count above 10,000/mcL, liver enzymes (AST and ALT) at or below 3 times the upper limit of normal, total bilirubin at or below 3 times the upper limit of normal, creatinine clearance of at least 50 mL/min, and left ventricular ejection fraction of at least 40% by electrocardiography
- Ability to understand and willingness to sign written informed consent and complete study procedures
You will not qualify if you...
- Diagnosis of acute promyelocytic leukemia (APL), the M3 subtype of AML
- Active central nervous system leukemia
- Previous treatment with CDK8 and/or CDK19-targeted therapies
- Major surgery within 28 days before first dose of study drug
- Hematopoietic stem cell transplant within 120 days before first dose of study drug
- Currently pregnant or breastfeeding; females of childbearing potential must have a negative pregnancy test within 72 hours before first dose
- Uncontrolled illnesses limiting life expectancy or ability to complete study, including active Grade 2 or higher graft versus host disease or immunosuppressive treatment for it, uncontrolled infections or inflammatory conditions, significant liver diseases, drug-induced pneumonitis, significant cardiac dysfunction (including recent myocardial infarction, severe heart failure, uncontrolled arrhythmias, or poorly controlled angina), history of ventricular arrhythmia or prolonged QTc interval
- Prior malignancies unless disease-free for 5 years or specific exceptions
- Gastrointestinal conditions affecting absorption of study drugs
- Use of medications or substances that strongly affect metabolism of RVU120 or venetoclax
- Known allergy or hypersensitivity to components of RVU120 or venetoclax formulations
AI-Screening
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Trial Site Locations
Total: 37 locations
1
Centre Hospitalier Universitaire Grenoble Alpes
Grenoble, France, 38043
Actively Recruiting
2
Centre Hospitalier Le Mans
Le Mans, France, 72037
Actively Recruiting
3
Centre Hospitalier Universitaire De Lille
Lille, France, 59000
Actively Recruiting
4
Institut Paoli-Calmettes
Marseille, France, 13009
Actively Recruiting
5
Centre Hospitalier Universitaire De Nice
Nice, France, 06200
Actively Recruiting
6
Centre Hospitalier Universitaire De Nimes
Nîmes, France, 30900
Actively Recruiting
7
Assistance Publique Hopitaux De Paris
Paris, France, 75010
Actively Recruiting
8
Centre Henri Becquerel
Rouen, France, 76000
Actively Recruiting
9
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola, Forlì-Cesena, Italy, 47014
Actively Recruiting
10
Azienda Ospedaliero Universitaria Delle Marche
Ancona, Italy, 60126
Actively Recruiting
11
Univerisity of Bologna Policlinico Sant'Orsola
Bologna, Italy, 40138
Actively Recruiting
12
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Brescia, Italy, 25123
Actively Recruiting
13
Ospedale Vito Fazzi Lecce
Lecce, Italy, 73100
Actively Recruiting
14
AUSL Romagna - Ospedale S.M. Delle Croci
Ravenna, Italy
Actively Recruiting
15
Azienda Ospedaliera Policlinico Universitario Tor Vergata
Roma, Italy, 00133
Actively Recruiting
16
Istituto Clinico Humanitas
Rozzano, Italy
Actively Recruiting
17
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Turin, Italy, 10126
Actively Recruiting
18
MTZ Clinical Research
Warsaw, Mazowieckie Województwo, Poland, 02-172
Actively Recruiting
19
Wojewodzki Szpital Specjalistyczny w Bialej Podlaskiej
Biała Podlaska, Poland, 21-500
Actively Recruiting
20
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland, 80-214
Actively Recruiting
21
PRATIA Onkologia Katowice
Katowice, Poland
Actively Recruiting
22
Wojewodzki Szpital Zespolony Im.L.Rydygiera w Toruniu
Torun, Poland, 87-100
Actively Recruiting
23
Instytut Hematologii i Transfuzjologii
Warsaw, Poland, 02-776
Actively Recruiting
24
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
Warsaw, Poland, 04-141
Actively Recruiting
25
Specjalistyczny Szpital Im. Dra Alfreda Sokolowskiego
Wałbrzych, Poland, 58-309
Actively Recruiting
26
Dolnoslaskie Centrum Onkologii Pulmonologii i Hematologii
Wroclaw, Poland, 53-439
Actively Recruiting
27
Szpital Uniwersytecki Imienia Karola Marcinkowskiego w Zielonej Gorze Sp. z o. o.
Zielona Góra, Poland, 65-046
Actively Recruiting
28
Hospital Del Mar
Barcelona, Spain, 08003
Actively Recruiting
29
Hospital De La Santa Creu I Sant Pau
Barcelona, Spain, 08041
Actively Recruiting
30
Institut Catala D'oncologia
Barcelona, Spain, 08908
Not Yet Recruiting
31
Hospital San Pedro De Alcantara
Cáceres, Spain, 10002
Actively Recruiting
32
MD Anderson Cancer Center
Madrid, Spain, 28033
Actively Recruiting
33
Hospital Universitario La Paz
Madrid, Spain, 28046
Actively Recruiting
34
Hospital Universitario Regional De Malaga
Málaga, Spain, 29010
Actively Recruiting
35
Clinica Universidad De Navarra
Pamplona, Spain, 31008
Actively Recruiting
36
University Hospital Virgen Del Rocio S.L.
Seville, Spain, 41013
Actively Recruiting
37
Hospital Universitario Y Politecnico La Fe
Valencia, Spain, 46026
Actively Recruiting
Research Team
H
Head of Clinical Operations
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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