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

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

Trial Details

NCT ID
NCT06191263
Phase
PHASE2
Sponsor
Ryvu Therapeutics SA
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • RVU120
  • Venetoclax
Locations (sample)
  • Grenoble, France|45.17869,5.71479
  • Le Mans, France|48.0021,0.20251
  • Lille, France|50.63391,3.05512
  • Marseille, France|43.29695,5.38107
  • Nice, France|43.70313,7.26608

Key Eligibility 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

For full eligibility, visit ClinicalTrials.gov.

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