Safety and Efficacy of RVU120 Combined With Venetoclax for Treatment of Relapsed/Refractory AML
NCT ID: NCT06191263
Last Updated: 2025-04-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
98 participants
INTERVENTIONAL
2024-01-05
2026-09-30
Brief Summary
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Detailed Description
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In Part 2, it will be assessed whether the recommended dose level from Part 1 reaches the targetted response criteria, and if reached, Part 3 will be initiated to further evaluate the efficacy and safety of the recommended doses in a larger population.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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RVU120 + Venetoclax
RVU120 oral capsule, 125 or 250 mg administered every other day on Days 1-13 of each 21-day cycle of treatment, combined with venetoclax oral tablet, 200 or 400 mg administered once daily on Days 1-14 of each 21-day cycle of treatment
RVU120
RVU120 is a potent, selective inhibitor of CDK8 and its paralog CDK19
Venetoclax
Venetoclax specifically binds to BCL-2, displacing proapoptotic proteins and triggering events that lead to apoptosis
Interventions
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RVU120
RVU120 is a potent, selective inhibitor of CDK8 and its paralog CDK19
Venetoclax
Venetoclax specifically binds to BCL-2, displacing proapoptotic proteins and triggering events that lead to apoptosis
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients must have relapsed or refractory AML (per ELN 2022 criteria)
* Patients must have failed first-line treatment with venetoclax combined with a hypomethylating agent
* Patients must have no alternative therapeutic options likely to produce clinical benefit
* Patients must have ECOG performance status of 0 to 2
* Patients must have adequate end organ function defined as:
1. WBC \< 25 x 10(9)/L on Day 1 prior to first dose of study drug
2. Platelet count \> 10,000/mcL on Day 1 prior to first dose of study drug
3. AST (aspartate transaminase) and ALT (alanine transaminase) ≤ 3 x ULN (upper limit of normal)
4. Total bilirubin ≤ 3 x ULN
5. Creatinine clearance (Cockcroft \& Gault formula) ≥ 50 mL/min
6. LVEF (left ventricular ejection fraction) ≥ 40% by electrocardiography
* Subjects must have the ability to understand and the willingness to sign a written informed consent document and complete study related procedures
Exclusion Criteria
* Active CNS (central nervous system) leukemia
* Previous treatment with CDK8 and/or CDK19-targeted therapy
* Major surgery within 28 days prior to the first dose of study drug
* Hematopoietic stem cell transplant within 120 days prior to the first dose of study drug
* Currently pregnant or breast-feeding. Females of child bearing potential must have a negative serum pregnancy test within 72 hours prior to the first dose of study drug
* Uncontrolled intercurrent illness that could limit life expectancy or ability to complete study correlates. This includes but is not limited to:
1. Active, Grade ≥2 acute GVHD (graft versus host disease) or requirement for systemic immunosuppressive medication for GVHD
2. Evidence of ongoing or uncontrolled systemic bacterial, fungal or viral infection and acute inflammatory conditions (including pancreatitis)
3. Ongoing significant liver disease such as cirrhosis, drug-induced liver injury, active hepatitis, or chronic persistent hepatitis B and/or hepatitis C
4. Ongoing drug-induced pneumonitis
5. Significant cardiac dysfunction, defined as myocardial infarction within 12 months prior to the first dose of study drug, NYHA (New York Heart Association) Class III or IV heart failure, uncontrolled dysrhythmias, poorly controlled angina
6. History of ventricular arrhythmia or QTc ≥ 470 ms (Bazett's formula)
7. Prior history of malignancies other than AML, unless disease-free for 5 years or more or prior basal cell carcinoma of the skin, non-metastatic squamous cell carcinoma of the skin, carcinoma in situ of cervix, breast or bladder, and incidental histological finding of prostate cancer (TMN stage T1a or T1b)
* Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RVU120 and/or venetoclax
* 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
* Taking any medications, over-the-counter medications, foods or herbal supplements that are known to be strong or moderate inhibitors of CYP3A4 or P-gp (P-glycoprotein)
* Known allergy or hypersensitivity to any component of RVU120 or venetoclax formulations
18 Years
ALL
No
Sponsors
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Ryvu Therapeutics SA
INDUSTRY
Responsible Party
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Locations
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Centre Hospitalier Universitaire Grenoble Alpes
Grenoble, , France
Centre Hospitalier Le Mans
Le Mans, , France
Centre Hospitalier Universitaire De Lille
Lille, , France
Institut Paoli-Calmettes
Marseille, , France
Centre Hospitalier Universitaire De Nice
Nice, , France
Centre Hospitalier Universitaire De Nimes
Nîmes, , France
Assistance Publique Hopitaux De Paris
Paris, , France
Centre Henri Becquerel
Rouen, , France
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola, Forlì-Cesena, Italy
Azienda Ospedaliero Universitaria Delle Marche
Ancona, , Italy
Univerisity of Bologna Policlinico Sant'Orsola
Bologna, , Italy
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Brescia, , Italy
Ospedale Vito Fazzi Lecce
Lecce, , Italy
AUSL Romagna - Ospedale S.M. Delle Croci
Ravenna, , Italy
Azienda Ospedaliera Policlinico Universitario Tor Vergata
Roma, , Italy
Istituto Clinico Humanitas
Rozzano, , Italy
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Turin, , Italy
MTZ Clinical Research
Warsaw, Mazowieckie Województwo, Poland
Wojewodzki Szpital Specjalistyczny w Bialej Podlaskiej
Biała Podlaska, , Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, , Poland
PRATIA Onkologia Katowice
Katowice, , Poland
Wojewodzki Szpital Zespolony Im.L.Rydygiera w Toruniu
Torun, , Poland
Instytut Hematologii i Transfuzjologii
Warsaw, , Poland
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
Warsaw, , Poland
Specjalistyczny Szpital Im. Dra Alfreda Sokolowskiego
Wałbrzych, , Poland
Dolnoslaskie Centrum Onkologii Pulmonologii i Hematologii
Wroclaw, , Poland
Szpital Uniwersytecki Imienia Karola Marcinkowskiego w Zielonej Gorze Sp. z o. o.
Zielona Góra, , Poland
Hospital Del Mar
Barcelona, , Spain
Hospital De La Santa Creu I Sant Pau
Barcelona, , Spain
Institut Catala D'oncologia
Barcelona, , Spain
Hospital San Pedro De Alcantara
Cáceres, , Spain
MD Anderson Cancer Center
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario Regional De Malaga
Málaga, , Spain
Clinica Universidad De Navarra
Pamplona, , Spain
University Hospital Virgen Del Rocio S.L.
Seville, , Spain
Hospital Universitario Y Politecnico La Fe
Valencia, , Spain
Countries
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Central Contacts
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Facility Contacts
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Claude-Eric Bulabois, Dr
Role: primary
Kamel Laribi, Dr
Role: primary
Laure Goursaud, Dr
Role: primary
Sylvian Garciaz, Dr
Role: primary
Thomas Cluzeau, Dr
Role: primary
Stefan Wickenhauser, Dr
Role: primary
Pierre Fenaux, Dr
Role: primary
Emilie Lemasle-Hue, Dr
Role: primary
Debora Capelli, Dr
Role: primary
Cristina Papayannidis, Prof.
Role: primary
Erika Borlenghi, Dr
Role: primary
Nicola Di Renzo, Dr
Role: primary
Adriano Venditti, Prof.
Role: primary
Ernesta Audisio, Dr
Role: primary
Piotr Centkowski, Dr
Role: primary
Witold Prejzner, Dr
Role: primary
Marcin Rymko, Dr
Role: primary
Ewa Lech-Marańda, Prof.
Role: primary
Krzysztof Gawroński, Dr
Role: primary
Aleksandra Butrym, Prof.
Role: primary
Jarosław Dybko, Dr
Role: primary
Emilian Snarski, Prof.
Role: primary
Sara Garcia Avila, Dr
Role: primary
Guadalupe Oñate, Dr
Role: primary
Montserrat Arnan Sangerman, Dr
Role: primary
Juan Miguel Bergua Burgués, Dr
Role: primary
Adolfo De La Fuente, Dr
Role: primary
Irene Sanchez Vandillo, Dr
Role: primary
Alejandro Luis Contento Gonzalo, Dr
Role: primary
Ana Alfonso Pierola, Dr
Role: primary
Jose Antonio Perez Simón, Dr
Role: primary
Pau Montesinos Fernandez, Dr
Role: primary
Other Identifiers
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RIVER-81
Identifier Type: -
Identifier Source: org_study_id
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