Clinical Trial

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

Study acronym: RIVER-81
Recruiting Phase 2
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Record status
This record was last updated April 13, 2025 (before its estimated February 2026 completion). Its status may not reflect the trial's current state.
Summary
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 the same doses assessed in Part 2
Protocol Amendment History 8 amendments
This ClinicalTrials.gov record has been amended 8 times since 2023-12-19; most recent amendment 2025-04-09.
Status change: Not Yet Recruiting → Recruiting 2024-01-10
Trial Details
NCT Number NCT06191263
Lead Sponsor Ryvu Therapeutics SA
Conditions Acute Myeloid Leukemia
Enrollment 98 participants
Start Date 2024-01-05
Primary Completion 2026-02 (estimated)
Study Completion 2026-09 (estimated)
Updated on ClinicalTrials.gov 2025-04-13