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Can a CDK8/CDK19 blocker help when leukemia and MDS return?

NCT ID NCT06268574

Disease control Sponsor: Ryvu Therapeutics SA Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 15, 2026 · Last updated Sep 17, 2026 · Updated 2 times

Summary

Researchers are testing an experimental drug called RVU120 in adults with acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS) that has come back or stopped responding to treatment. RVU120 blocks two proteins, CDK8 and CDK19, that may help cancer cells grow. The trial has two parts: the first checks safety and early signs of anti-tumor activity, and the second gives the drug to more patients to further assess safety and response. Participants must have already tried first-line treatment and have no other good options.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
RVU120, an experimental drug that blocks the CDK8 and CDK19 proteins
What this could lead to
If it works, RVU120 could offer a new option for people whose AML or high-risk MDS has come back or stopped responding to standard treatment.
What could go wrong
This is a Phase 2 trial in a small group of very sick patients, so the drug may not shrink their cancer or may cause side effects that make it hard to tolerate. Results in this group may not apply to other patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

62 people

The number who actually took part.

Started

Jan 2024

Finished

Sep 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 * Patients must have adequate end organ function defined as: 1. WBC \< 30 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. Serum albumin ≥ 25 g/L (2.5 g/dL) 4. 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) 5. AST (aspartate transaminase) and ALT (alanine transaminase) ≤ 3 x ULN (upper limit of normal) 6. Total bilirubin ≤ 3 x ULN 7. Creatinine clearance (Cockcroft \& Gault formula) ≥ 30 mL/min Exclusion Criteria: * 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 * 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.

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia myelodysplastic syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute myeloid leukemia (AML) High risk myelodysplastic syndrome

Contacts and locations

Locations

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, 20162, Italy

  • Azienda Ospedaliera Policlinico Universitario Tor Vergata

    Roma, 00133, Italy

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

    Turin, 10126, Italy

  • Azienda Ospedaliero Universitaria Delle Marche

    Ancona, 60126, Italy

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, 56126, Italy

  • Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

    Brescia, 25123, Italy

  • Careggi University Hospital

    Florence, 50134, Italy

  • Centre Hospitalier Le Mans

    Le Mans, France

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

    Nice, France

  • Centre Hospitalier Universitaire Grenoble Alpes

    La Tronche, France

  • Centre Hospitalier Universitaire de Lille (CHU Lille)

    Lille, France

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

    Nîmes, France

  • Clinica Universidad de Navarra

    Pamplona, Spain

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

    Cáceres, Spain

  • Dolnoslaskie Centrum Onkologii Pulmonologii i Hematologii

    Wroclaw, 53-439, Poland

  • Hospital Regional Universitario de Málaga

    Málaga, Spain

  • Hospital Universitario La Fe

    Valencia, Spain

  • Hospital Universitario La Paz (HULP)

    Madrid, Spain

  • Hospital de la Santa Creu i de Sant Pau

    Barcelona, Spain

  • Hospital del Mar

    Barcelona, Spain

  • Humanitas Mirasole S.p.A.

    Rozzano, 20089, Italy

  • Institut Catala d'Oncologia Hospitalet

    Barcelona, Spain

  • Institut Paoli Calmettes (IPC)

    Marseille, France

  • Instytut Hematologii I Transfuzjologii

    Warsaw, 02-776, Poland

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

    Meldola, 47014, Italy

  • MD Anderson Cancer Center Madrid

    Madrid, Spain

  • MICS Centrum Medyczne Toruń

    Torun, 87-100, Poland

  • MTZ Clinical Research

    Warsaw, Mazowieckie Województwo, 02-172, Poland

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

    Gliwice, 44-102, Poland

  • Ospedale Vito Fazzi Lecce

    Lecce, 73100, Italy

  • Pratia Hematologia Sp. z o.o.

    Katowice, 40-519, Poland

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

    Paris, France

  • Specjalistyczny Szpital Im. Dra Alfreda Sokolowskiego

    Wałbrzych, 58-309, Poland

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

    Zielona Góra, 65-046, Poland

  • Szpital Wojewodzki Im. Dr. Ludwika Rydygiera w Suwalkach

    Suwałki, 16-400, Poland

  • UNICANCER - Centre Henri-Becquerel

    Rouen, France

  • Univerisity of Bologna Policlinico Sant'Orsola

    Bologna, 40138, Italy

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-214, Poland

  • Virgen del Rocío University Hospital

    Seville, Spain

  • Wojewodzki Szpital Specjalistyczny w Bialej Podlaskiej

    Biała Podlaska, 21-500, Poland

  • Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy

    Warsaw, 04-141, Poland

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