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Acute Myeloid LeukemiaPhase 2RIVER-81NCT06191263

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

A Phase 2 study testing RVU120 and Venetoclax in people with Acute Myeloid Leukemia, run by Ryvu Therapeutics SA at 37 sites in 4 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Myeloid Leukemia
What is being tested?
RVU120 and Venetoclax
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
98 participants
Where
37 sitesin 4 countries
Study dates
5 Jan 2024to Aug 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have a diagnosis of AML (per 2022 WHO classification)
  • 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:
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  • WBC < 25 x 10(9)/L on Day 1 prior to first dose of study drug
  • Platelet count > 10,000/mcL on Day 1 prior to first dose of study drug
  • AST (aspartate transaminase) and ALT (alanine transaminase) ≤ 3 x ULN (upper limit of normal)
  • Total bilirubin ≤ 3 x ULN
  • Creatinine clearance (Cockcroft \& Gault formula) ≥ 50 mL/min
  • 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

Who cannot join

  • APL (acute promyelocytic leukemia), the M3 subtype of AML
  • 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
Show all 18Show fewer
  • Uncontrolled intercurrent illness that could limit life expectancy or ability to complete study correlates. This includes but is not limited to:
  • Active, Grade ≥2 acute GVHD (graft versus host disease) or requirement for systemic immunosuppressive medication for GVHD
  • Evidence of ongoing or uncontrolled systemic bacterial, fungal or viral infection and acute inflammatory conditions (including pancreatitis)
  • Ongoing significant liver disease such as cirrhosis, drug-induced liver injury, active hepatitis, or chronic persistent hepatitis B and/or hepatitis C
  • Ongoing drug-induced pneumonitis
  • 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
  • History of ventricular arrhythmia or QTc ≥ 470 ms (Bazett's formula)
  • 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

Trial locations and contacts

37 sites in 4 countries. Contact the study team or a site near you to ask about taking part.

Head of Clinical Operations contact

+48-12 -314-02-00

clinicaltrials@ryvu.com

37 sites in 4 countries

Poland10 sites, 6 recruiting

  • Wojewodzki Szpital Specjalistyczny w Bialej Podlaskiej

    Biała Podlaska, 21-500

    Terminated

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-214

    Witold Prejzner, Dr

    Witold Prejzner, Dr

    Recruiting

  • PRATIA Onkologia Katowice

    Katowice

    Sebastian Grosicki, Prof.

    Recruiting

  • Wojewodzki Szpital Zespolony Im.L.Rydygiera w Toruniu

    Torun, 87-100

    Terminated

  • Specjalistyczny Szpital Im. Dra Alfreda Sokolowskiego

    Wałbrzych, 58-309

    Aleksandra Butrym, Prof.

    Aleksandra Butrym, Prof.

    Recruiting

  • MTZ Clinical Research

    Warsaw, Mazowieckie Województwo, 02-172

    Krzysztof Mądry, +48 22 572 59 59, info@pratia.com

    Krzysztof Mądry

    Recruiting

  • Instytut Hematologii i Transfuzjologii

    Warsaw, 02-776

    Ewa Lech-Marańda, Prof.

    Ewa Lech-Marańda, Prof.

    Recruiting

  • Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy

    Warsaw, 04-141

    Terminated

  • Dolnoslaskie Centrum Onkologii Pulmonologii i Hematologii

    Wroclaw, 53-439

    Jarosław Dybko, Dr

    Jarosław Dybko, Dr

    Recruiting

  • Szpital Uniwersytecki Imienia Karola Marcinkowskiego w Zielonej Gorze Sp. z o. o.

    Zielona Góra, 65-046

    Terminated

Other trials in Poland

Spain10 sites, 10 recruiting

  • Hospital Del Mar

    Barcelona, 08003

    Sara Garcia Avila, Dr

    Sara Garcia Avila, Dr

    Recruiting

  • Hospital De La Santa Creu I Sant Pau

    Barcelona, 08041

    Guadalupe Oñate, Dr

    Guadalupe Oñate, Dr

    Recruiting

  • Institut Catala D'oncologia

    Barcelona, 08908

    Montserrat Arnan Sangerman, Dr

    Montserrat Arnan Sangerman, Dr

    Not yet recruiting

  • Hospital San Pedro De Alcantara

    Cáceres, 10002

    Juan Miguel Bergua Burgués, Dr

    Juan Miguel Bergua Burgués, Dr

    Recruiting

  • MD Anderson Cancer Center

    Madrid, 28033

    Adolfo De La Fuente, Dr

    Adolfo De La Fuente, Dr

    Recruiting

  • Hospital Universitario La Paz

    Madrid, 28046

    Irene Sanchez Vandillo, Dr

    Irene Sanchez Vandillo, Dr

    Recruiting

  • Hospital Universitario Regional De Malaga

    Málaga, 29010

    Alejandro Luis Contento Gonzalo, Dr

    Alejandro Luis Contento Gonzalo, Dr

    Recruiting

  • Clinica Universidad De Navarra

    Pamplona, 31008

    Ana Alfonso Pierola, Dr

    Ana Alfonso Pierola, Dr

    Recruiting

  • University Hospital Virgen Del Rocio S.L.

    Seville, 41013

    Jose Antonio Perez Simón, Dr

    Jose Antonio Perez Simón, Dr

    Recruiting

  • Hospital Universitario Y Politecnico La Fe

    Valencia, 46026

    Pau Montesinos Fernandez, Dr

    Pau Montesinos Fernandez, Dr

    Recruiting

Other trials in Spain

Italy9 sites, 9 recruiting

  • Azienda Ospedaliero Universitaria Delle Marche

    Ancona, 60126

    Debora Capelli, Dr

    Debora Capelli, Dr

    Recruiting

  • Univerisity of Bologna Policlinico Sant'Orsola

    Bologna, 40138

    Cristina Papayannidis, Prof.

    Cristina Papayannidis, Prof.

    Recruiting

  • Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

    Brescia, 25123

    Erika Borlenghi, Dr

    Erika Borlenghi, Dr

    Recruiting

  • Ospedale Vito Fazzi Lecce

    Lecce, 73100

    Nicola Di Renzo, Dr

    Nicola Di Renzo, Dr

    Recruiting

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

    Meldola, Forlì-Cesena, 47014

    Maria Giannini, Dr, +39 0543 739100, info@irst.emr.it

    Maria Giannini, Dr

    Recruiting

  • AUSL Romagna - Ospedale S.M. Delle Croci

    Ravenna

    Giovanni Marconi, Prof.

    Recruiting

  • Azienda Ospedaliera Policlinico Universitario Tor Vergata

    Roma, 00133

    Adriano Venditti, Prof.

    Adriano Venditti, Prof.

    Recruiting

  • Istituto Clinico Humanitas

    Rozzano

    Matteo Della Porta, Prof.

    Recruiting

  • Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino

    Turin, 10126

    Ernesta Audisio, Dr

    Ernesta Audisio, Dr

    Recruiting

Other trials in Italy

France8 sites, 8 recruiting

  • Centre Hospitalier Universitaire Grenoble Alpes

    Grenoble, 38043

    Claude-Eric Bulabois, Dr

    Claude-Eric Bulabois, Dr

    Recruiting

  • Centre Hospitalier Le Mans

    Le Mans, 72037

    Kamel Laribi, Dr

    Kamel Laribi, Dr

    Recruiting

  • Centre Hospitalier Universitaire De Lille

    Lille, 59000

    Laure Goursaud, Dr

    Laure Goursaud, Dr

    Recruiting

  • Institut Paoli-Calmettes

    Marseille, 13009

    Sylvian Garciaz, Dr

    Sylvian Garciaz, Dr

    Recruiting

  • Centre Hospitalier Universitaire De Nice

    Nice, 06200

    Thomas Cluzeau, Dr

    Thomas Cluzeau, Dr

    Recruiting

  • Centre Hospitalier Universitaire De Nimes

    Nîmes, 30900

    Stefan Wickenhauser, Dr

    Stefan Wickenhauser, Dr

    Recruiting

  • Assistance Publique Hopitaux De Paris

    Paris, 75010

    Pierre Fenaux, Dr

    Pierre Fenaux, Dr

    Recruiting

  • Centre Henri Becquerel

    Rouen, 76000

    Emilie Lemasle-Hue, Dr

    Emilie Lemasle-Hue, Dr

    Recruiting

Other trials in France

About this study

Official title: 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

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

Read the detailed description

In Part 1 dose-escalation participants will receive escalating oral doses of RVU120 starting at 125 mg administered every other day on days 1-13, and escalating oral doses of venetoclax starting with 200 mg administered daily on days 1-14 of each 21-day cycle of treatment. The recommended doses for further study will be based on the observed safety, tolerance, PK and PD.

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.

Being tested
RVU120, Venetoclax
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RVU120Drug

    Also called SEL120

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

  • VenetoclaxDrug

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

Study groups in NCT06191263
Study groupRoleWhat they receive
RVU120 + VenetoclaxExperimentalRVU120 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
Receives: Drug: RVU120; Drug: Venetoclax

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. (Part 1) recommended doses of RVU120 and venetoclax for further study

    Incidence and severity of toxicities and number of dose limiting toxicities per dose cohort

    Measured: approx. 12 months

  2. (Parts 2 & 3) CR/CRh rate (Complete Remission/Complete Remission with incomplete Hematologic Recovery)

    Preliminary efficacy of RVU120 combined with venetoclax to recommended doses from Part 1. A response of CRh is defined as bone marrow with <5% blasts, peripheral blood neutrophil count >0.5 x 10(3)/mcL, and peripheral blood platelet count of >0.5 x 10(5)/mcL

    Measured: approx. 36 months

Secondary outcomes (8)

  1. Incidence and severity of adverse events (safety and tolerability)

    Number and grade of adverse events assessed by CTCAE v5.0

    Measured: approx. 36 months

  2. Duration of response

    Time from randomization to disease progression or death in patients who achieve CR/CRh

    Measured: approx. 36 months

  3. Post baseline transfusion independence rate

    Transfusion independence is defined as a period of 56 days with no transfusion between the first dose of study drug and the last dose of study drug + 30 days. The rate of conversion of red blood cells (RBC) and platelets is defined as percentage of participants being post-baseline transfusion independent from baseline transfusion dependent

    Measured: approx. 36 months

  4. Progression-free survival

    Time from randomization until first evidence of disease progression or death

    Measured: approx. 36 months

  5. Relapse-free survival

    Number of participants alive without relapse

    Measured: approx. 36 months

  6. Overall survival

    Time from randomization to death

    Measured: approx. 36 months

  7. Percentage of patients bridged to hematopoietic stem cell transplantation

    Number of hematopoietic stem cell transplantations following response

    Measured: approx. 36 months

  8. (Parts 2 & 3) Impact of treatment on HM-PRO (hematologic malignancy specific patient reported outcome measure)

    The HM-PRO consists of two scales, Part A (Impact) that measures treatment impact on patient's health-related quality of life using a three-point Likert scale (Not at all, A little, A lot) and Part B (Signs and Symptoms) that captures the severity of disease or treatment related signs and symptoms on a three-point Likert scale (Not at all, Mild, Severe).

    Measured: approx. 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2024
  2. Study start5 Jan 2024
  3. Primary completionAug 2027 (estimated)
  4. Study completionAug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
98 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06191263
Sponsor's protocol ID
RIVER-81
Acronym
RIVER-81
Status last verified
Sep 2026
First submitted
19 Dec 2023
Last updated
18 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing RVU120 and Venetoclax in people with Acute Myeloid Leukemia, run by Ryvu Therapeutics SA at 37 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in Poland, Spain, Italy, France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Head of Clinical Operations (+48-12 -314-02-00, clinicaltrials@ryvu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

(Part 1) recommended doses of RVU120 and venetoclax for further study (time frame: approx. 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06191263.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.

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