RecruitingPhase 2NCT06191263

Safety and Efficacy of RVU120 Combined With Venetoclax for Treatment of Relapsed/Refractory AML

A Multicenter, Open-Label, Dose-Finding Clinical Trial to Assess the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Efficacy of RVU120 in Combination With Venetoclax in Participants With Acute Myeloid Leukemia Who Failed Prior Therapy With Ventoclax and a Hypomethylating Agent

Sponsor

Ryvu Therapeutics SA

Enrollment

98 participants

Start Date

Jan 5, 2024

Study Type

INTERVENTIONAL

Conditions

Acute Myeloid Leukemia

Summary

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

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug combination — RVU120 (a CDK8/19 inhibitor) plus venetoclax — for adults with acute myeloid leukemia (AML) that has come back or stopped responding after standard treatment including venetoclax-based therapy. **You may be eligible if...** - You are an adult with a confirmed AML diagnosis - Your AML has relapsed or is refractory (didn't respond) to prior treatment, including treatment with venetoclax plus a hypomethylating agent - You have no other treatment options likely to provide benefit - Your general health (ECOG 0–2) and organ function (kidney, liver, heart) meet study requirements **You may NOT be eligible if...** - You have a specific AML subtype called acute promyelocytic leukemia (APL) - You have AML that has spread to the brain or spinal fluid - You have previously received a CDK8 or CDK19 targeted therapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRVU120

RVU120 is a potent, selective inhibitor of CDK8 and its paralog CDK19

DRUGVenetoclax

Venetoclax specifically binds to BCL-2, displacing proapoptotic proteins and triggering events that lead to apoptosis

Locations(37)

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

View Full Details on ClinicalTrials.gov

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NCT06191263

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