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Acute Myeloid Leukemia (AML)Phase 2RIVER-52NCT06268574

Safety and Efficacy of RVU120 for Treatment of Relapsed/Refractory AML

A Phase 2 study testing RVU120 in people with Acute Myeloid Leukemia (AML) and High-risk Myelodysplastic Syndrome, run by Ryvu Therapeutics SA at 41 sites in 4 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The goal of this study is to assess the safety, tolerability, anti-tumor activity (efficacy), pharmacokinetics (PK), and pharmacodynamics (PD) of the agent RVU120 when administered to adult patients with relapsed or refractory acute myeloid leukemia (AML) or relapsed or progressing high-risk myelodysplastic syndrome… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
RVU120
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
41 sitesin 4 countries
Study dates
23 Jan 2024to 5 Sep 2025
Phase
Phase 2
Are there results?
None posted in the registry

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

  • Subjects must sign a written informed consent document and complete study related procedures
  • Patients must have a diagnosis of AML or HR-MDS (per 2022 WHO classification) with MDS confirmed as high risk with IPSS-R
  • Patients must have relapsed or refractory AML (per ELN 2022 criteria)
  • Patients must have relapsed or progressing HR-MDS (per IWG response criteria)
  • Patients must have failed first-line treatment and have no alternative therapeutic options likely to produce clinical benefit
  • Patients must have ECOG performance status of 0 to 2
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  • Patients must have adequate end organ function defined as:
  • WBC < 30 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
  • Serum albumin ≥ 25 g/L (2.5 g/dL)
  • Normal coagulation (elevated international normalized ratio [INR], prothrombin time or activated partial thromboplastin time [APTT] <1.3 x the upper limit of normal [ULN] acceptable)
  • AST (aspartate transaminase) and ALT (alanine transaminase) ≤ 3 x ULN (upper limit of normal)
  • Total bilirubin ≤ 3 x ULN
  • Creatinine clearance (Cockcroft \& Gault formula) ≥ 30 mL/min

Who cannot join

  • Active central nervous system (CNS) leukemia.
  • Diagnosis of acute promyelocytic leukemia (APL), the M3 subtype of AML.
  • Previous treatment with CDK8 and/or CDK19-targeted therapy.
  • Major surgery within 28 days prior to first dose of study drug.
  • Hematopoietic stem cell transplant within 120 days prior to first dose of study drug.
  • Active, ≥Grade 2 acute graft versus host disease (GVHD), active moderate-to-severe chronic GVHD, or requirement for systemic immunosuppressive medications for GVHD
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  • Evidence of ongoing and uncontrolled systemic bacterial, fungal, or viral infection and acute inflammatory conditions (including pancreatitis).
  • Known seropositivity or history of active viral infection with human immunodeficiency virus (HIV).
  • Ongoing significant liver disease
  • Impairment of gastrointestinal function or gastrointestinal disease
  • Ongoing drug-induced pneumonitis.
  • Concurrent participation in another investigational clinical trial.
  • Taking any medications, herbal supplements, or other substances (including smoking) that may interfere with the metabolism of the study drug
  • Significant cardiac dysfunction defined as myocardial infarction within 12 months of first dose of study drug, New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled dysrhythmias, poorly controlled angina or left ventricular ejection fraction (LVEF) <40% as per echocardiography or multiple gated acquisition (MUGA) scan.
  • History of ventricular arrhythmia, or QTc ≥470 ms (Bazett's formula).
  • Prior history of malignancies other than AML, unless the participant has been free of the disease for 5 years or more prior to Screening
  • Pregnant or breast-feeding.

Trial locations and contacts

41 sites in 4 countries.

41 sites in 4 countries

Poland12 sites

  • Wojewodzki Szpital Specjalistyczny w Bialej Podlaskiej

    Biała Podlaska, 21-500

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-214

  • Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy

    Gliwice, 44-102

  • Pratia Hematologia Sp. z o.o.

    Katowice, 40-519

  • Szpital Wojewodzki Im. Dr. Ludwika Rydygiera w Suwalkach

    Suwałki, 16-400

  • MICS Centrum Medyczne Toruń

    Torun, 87-100

  • Specjalistyczny Szpital Im. Dra Alfreda Sokolowskiego

    Wałbrzych, 58-309

  • MTZ Clinical Research

    Warsaw, Mazowieckie Województwo, 02-172

  • Instytut Hematologii I Transfuzjologii

    Warsaw, 02-776

  • Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy

    Warsaw, 04-141

  • Dolnoslaskie Centrum Onkologii Pulmonologii i Hematologii

    Wroclaw, 53-439

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

    Zielona Góra, 65-046

Other trials in Poland

Italy11 sites

  • Azienda Ospedaliero Universitaria Delle Marche

    Ancona, 60126

  • Univerisity of Bologna Policlinico Sant'Orsola

    Bologna, 40138

  • Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

    Brescia, 25123

  • Careggi University Hospital

    Florence, 50134

  • Ospedale Vito Fazzi Lecce

    Lecce, 73100

  • Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.

    Meldola, 47014

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, 20162

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, 56126

  • Azienda Ospedaliera Policlinico Universitario Tor Vergata

    Roma, 00133

  • Humanitas Mirasole S.p.A.

    Rozzano, 20089

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

    Turin, 10126

Other trials in Italy

Spain10 sites

  • Hospital de la Santa Creu i de Sant Pau

    Barcelona

  • Hospital del Mar

    Barcelona

  • Institut Catala d'Oncologia Hospitalet

    Barcelona

  • Complejo Hospitalario De Caceres - Hospital General San Pedro De Alcantara

    Cáceres

  • Hospital Universitario La Paz (HULP)

    Madrid

  • MD Anderson Cancer Center Madrid

    Madrid

  • Hospital Regional Universitario de Málaga

    Málaga

  • Clinica Universidad de Navarra

    Pamplona

  • Virgen del Rocío University Hospital

    Seville

  • Hospital Universitario La Fe

    Valencia

Other trials in Spain

France8 sites

  • Centre Hospitalier Universitaire Grenoble Alpes

    La Tronche

  • Centre Hospitalier Le Mans

    Le Mans

  • Centre Hospitalier Universitaire de Lille (CHU Lille)

    Lille

  • Institut Paoli Calmettes (IPC)

    Marseille

  • Centre Hospitalier Universitaire (CHU) de Nice - Hopital L'Archet I

    Nice

  • Centre Hospitalier Universitaire de Nimes (CHU) - Institut de Cancerologie du Gard

    Nîmes

  • Publique-Hopitaux de Paris (AP-HP) - Hopital Saint-Louis

    Paris

  • UNICANCER - Centre Henri-Becquerel

    Rouen

Other trials in France

About this study

Official title: A Multicenter, Open-Label Clinical Trial of RVU120 in Patients With Relapsed or Refractory High-Risk Myelodysplastic Syndrome or Acute Myeloid Leukemia With or Without NPM1 Mutation (RIVER-52)

The goal of this study is to assess the safety, tolerability, anti-tumor activity (efficacy), pharmacokinetics (PK), and pharmacodynamics (PD) of the agent RVU120 when administered to adult patients with relapsed or refractory acute myeloid leukemia (AML) or relapsed or progressing high-risk myelodysplastic syndrome (HR-MDS) and who have no alternative therapies available. The study consists of two parts. Part 1 will assess the safety and tolerability of the dosages given and the level of anti-tumor activity or clinical response. Based on the results from part 1 the study will continue to enrol patient into Part 2 which will continue to evaluate safety and tolerability and anti-tumor activity in a larger number of patients.

Read the detailed description

Patients entering the study will undergo a Screening Period of up to 21 days, a Treatment Period where they will take the drug every other day (7 times in 13 days) in cycles of 21 days, an End of Treatment period (lasting approximately 30 days after last dose), and a 1-year Follow-up Period where participants will be contacted every 3 months for progression and survival status. In Part 1, patients with AML or HR-MDS will be enrolled. All patients will receive RVU120 until the patient meets eligibility for transplant, until there is disease progression or if there are signs of intolerance. A patient may withdraw from the study at any time at their own request or may be withdrawn at any time at the discretion of the Investigator. Depending on the outcome of part 1, part 2 may include patients with HR-MDS and AML irrespective of NPM1 mutation status.

Being tested
RVU120
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

Study groups in NCT06268574
Study groupRoleWhat they receive
RVU120 single agentExperimentalRVU120 oral capsules administered at dose of 250 mg every other day on Days 1-13 of each 21-day cycle of treatment.
Receives: Drug: RVU120

What is being measured

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

  1. Complete Remission (CR), with and without measurable residual disease (MRD)

    Rate of CR, CRh, or CRi

    Measured: 12 months

Secondary outcomes (11)

  1. Overall response rate

    Overall response rate including CR, CRh, CRi, MLFS, or PR in AML patients or CR, PR, or marrow CR HR-MDS patients

    Measured: 12 months

  2. Duration of response

    Time from first response to hematologial replase or death

    Measured: 12 months

  3. Progression-free survival

    Time from first treatment to the first occurrence of disease progression or death

    Measured: 12 months

  4. Overall survival

    Time from first treatment to death

    Measured: 12 months

  5. Incidence of Adverse Events (Safety and Tolerability)

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

    Measured: Up to 24 months

  6. Percentage of participants bridged to hematopoietic stem cell transplantation

    Number of hematopoietic stem cell transplantations following response

    Measured: 12 months

  7. Maximum Plasma Concentration (Cmax)

    Assessment of the peak plasma concentration (Cmax)

    Measured: 12 months

  8. Maximum Plasma Concentration (Tmax)

    Assessment of the time to peak plasma concentration (Tmax)

    Measured: 12 months

  9. Area Under the Concentration Time-Curve (AUC)

    Assessed of the area under the plasma concentration versus time curve (AUC)

    Measured: 12 months

  10. Impact of treatment on hematological malignancy patient-reported outcomes (HM-PRO)

    Assess changes in summary scores of the HM-PRO using a three point impact scale (Not at all, A little, A lot) and a three-point severity scale (Not at all, Mild, Severe)

    Measured: Up to 12 months

  11. Impact of treatment on health-related quality of life (QOL-E)

    Assess changes in summary scores of the QOL-E questionnaires using a four point scale in order of impact or severity from better to worse outcome (eg, Never, Rarely, Sometimes, Often)

    Measured: Up to 12 months

Timeline

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

  1. First posted20 Feb 2024
  2. Study start23 Jan 2024
  3. Primary completion30 Jun 2025
  4. Study completion5 Sep 2025

Why it stopped: Sponsor decision

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
Model description
Single Group Assignment
Masking
None (open label)
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06268574
Sponsor's protocol ID
RIVER-52
Acronym
RIVER-52
Status last verified
Sep 2026
First submitted
5 Jan 2024
Last updated
16 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 in people with Acute Myeloid Leukemia (AML) and High-risk Myelodysplastic Syndrome, run by Ryvu Therapeutics SA at 41 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 14 inclusion and 17 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: stopped early, as of the sponsor's last update on 16 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 41 sites in Poland, Italy, Spain, 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?

The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete Remission (CR), with and without measurable residual disease (MRD) (time frame: 12 months). 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 NCT06268574.

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 16 Sep 2026.

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