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Two-Drug combo targets leukemia that outsmarted its first treatment

NCT ID NCT06191263

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 study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 18, 2026 · Updated 2 times

Summary

Researchers are testing whether adding an experimental drug called RVU120 to venetoclax can help adults with acute myeloid leukemia (AML) that has come back or stopped responding to earlier venetoclax-based treatment. The trial enrolls about 98 adults who have already failed a hypomethylating agent plus venetoclax and have few other options. It runs in three parts: first to find safe doses of the two drugs together, then to check safety and response rates, and finally to confirm those results in a larger group. The main goal is to see how many participants achieve complete remission or complete remission with incomplete blood count recovery.

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, given with venetoclax
What this could lead to
If the combination works, it could offer a new option for people with AML whose cancer has stopped responding to venetoclax-based therapy, a group with few remaining choices.
What could go wrong
This is a mid-stage trial in a hard-to-treat population, and combining two drugs can add side effects. The combination may not shrink the leukemia, and results in this small group may not apply to everyone.

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

About 98 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2024

Expected to finish

Aug 2027

An estimate. End dates often move.

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: * 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: 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: * 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 * 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

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia

As listed by the trial registrant

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

Acute myeloid leukemia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    33 sites in 4 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AUSL Romagna - Ospedale S.M. Delle Croci

    RECRUITING

    Ravenna, Italy

  • Assistance Publique Hopitaux De Paris

    RECRUITING

    Paris, 75010, France

  • Azienda Ospedaliera Policlinico Universitario Tor Vergata

    RECRUITING

    Roma, 00133, Italy

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

    RECRUITING

    Turin, 10126, Italy

  • Azienda Ospedaliero Universitaria Delle Marche

    RECRUITING

    Ancona, 60126, Italy

  • Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

    RECRUITING

    Brescia, 25123, Italy

  • Centre Henri Becquerel

    RECRUITING

    Rouen, 76000, France

  • Centre Hospitalier Le Mans

    RECRUITING

    Le Mans, 72037, France

  • Centre Hospitalier Universitaire De Lille

    RECRUITING

    Lille, 59000, France

  • Centre Hospitalier Universitaire De Nice

    RECRUITING

    Nice, 06200, France

  • Centre Hospitalier Universitaire De Nimes

    RECRUITING

    Nîmes, 30900, France

  • Centre Hospitalier Universitaire Grenoble Alpes

    RECRUITING

    Grenoble, 38043, France

  • Clinica Universidad De Navarra

    RECRUITING

    Pamplona, 31008, Spain

  • Dolnoslaskie Centrum Onkologii Pulmonologii i Hematologii

    RECRUITING

    Wroclaw, 53-439, Poland

  • Hospital De La Santa Creu I Sant Pau

    RECRUITING

    Barcelona, 08041, Spain

  • Hospital Del Mar

    RECRUITING

    Barcelona, 08003, Spain

  • Hospital San Pedro De Alcantara

    RECRUITING

    Cáceres, 10002, Spain

  • Hospital Universitario La Paz

    RECRUITING

    Madrid, 28046, Spain

  • Hospital Universitario Regional De Malaga

    RECRUITING

    Málaga, 29010, Spain

  • Hospital Universitario Y Politecnico La Fe

    RECRUITING

    Valencia, 46026, Spain

  • Institut Catala D'oncologia

    NOT_YET_RECRUITING

    Barcelona, 08908, Spain

  • Institut Paoli-Calmettes

    RECRUITING

    Marseille, 13009, France

  • Instytut Hematologii i Transfuzjologii

    RECRUITING

    Warsaw, 02-776, Poland

  • Istituto Clinico Humanitas

    RECRUITING

    Rozzano, Italy

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

    RECRUITING

    Meldola, Forlì-Cesena, 47014, Italy

    Contact Email: •••••@•••••

  • MD Anderson Cancer Center

    RECRUITING

    Madrid, 28033, Spain

  • MTZ Clinical Research

    RECRUITING

    Warsaw, Mazowieckie Województwo, 02-172, Poland

    Contact Email: •••••@•••••

  • Ospedale Vito Fazzi Lecce

    RECRUITING

    Lecce, 73100, Italy

  • PRATIA Onkologia Katowice

    RECRUITING

    Katowice, Poland

  • Specjalistyczny Szpital Im. Dra Alfreda Sokolowskiego

    RECRUITING

    Wałbrzych, 58-309, Poland

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

    TERMINATED

    Zielona Góra, 65-046, Poland

  • Univerisity of Bologna Policlinico Sant'Orsola

    RECRUITING

    Bologna, 40138, Italy

  • University Hospital Virgen Del Rocio S.L.

    RECRUITING

    Seville, 41013, Spain

  • Uniwersyteckie Centrum Kliniczne

    RECRUITING

    Gdansk, 80-214, Poland

  • Wojewodzki Szpital Specjalistyczny w Bialej Podlaskiej

    TERMINATED

    Biała Podlaska, 21-500, Poland

  • Wojewodzki Szpital Zespolony Im.L.Rydygiera w Toruniu

    TERMINATED

    Torun, 87-100, Poland

  • Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy

    TERMINATED

    Warsaw, 04-141, Poland

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