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Combining RVU120 with Venetoclax for treating relapsed or 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

Phase 2 Interventional Ryvu Therapeutics SA · NCT06191263

This study is testing a new combination of two drugs, RVU120 and venetoclax, to see if they can help adults with relapsed or hard-to-treat acute myeloid leukemia feel better after previous treatments didn't work.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment98 (estimated)
Ages18 Years and up
SexAll
SponsorRyvu Therapeutics SA Industry-sponsored
Locations37 sites (Grenoble and 36 other locations)
Trial IDNCT06191263 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and efficacy of RVU120 in combination with venetoclax for adult patients with relapsed or refractory acute myeloid leukemia (AML) who have previously failed treatment. It consists of three parts: the first part focuses on determining safe and tolerated doses of both drugs, the second part assesses the efficacy and safety of these doses, and the third part confirms the findings in a larger cohort. Participants will receive escalating doses of RVU120 and venetoclax over a series of treatment cycles.

Who should consider this trial

Good fit: Ideal candidates are adults diagnosed with relapsed or refractory AML who have previously failed treatment with venetoclax and a hypomethylating agent.

Not a fit: Patients who have alternative therapeutic options likely to produce clinical benefit may not receive any benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with limited alternatives for relapsed or refractory AML.

How similar studies have performed: While this approach is novel in combining RVU120 with venetoclax, similar studies have shown promise in treating AML with targeted therapies.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Grenoble and 36 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Acute Myeloid Leukemia
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.