OncoMatch/Clinical Trials/NCT06191263
Safety and Efficacy of RVU120 Combined With Venetoclax for Treatment of Relapsed/Refractory AML
Is NCT06191263 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including RVU120 and Venetoclax for acute myeloid leukemia.
Treatment: RVU120 · Venetoclax — 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
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: venetoclax combined with a hypomethylating agent (venetoclax) — first-line
Patients must have failed first-line treatment with venetoclax combined with a hypomethylating agent
Cannot have received: CDK8 and/or CDK19-targeted therapy
Previous treatment with CDK8 and/or CDK19-targeted therapy
Cannot have received: hematopoietic stem cell transplant
Exception: within 120 days prior to the first dose of study drug
Hematopoietic stem cell transplant within 120 days prior to the first dose of study drug
Lab requirements
Blood counts
WBC < 25 x 10^9/L on Day 1 prior to first dose; Platelet count > 10,000/mcL on Day 1 prior to first dose
Kidney function
Creatinine clearance (Cockcroft & Gault formula) ≥ 50 mL/min
Liver function
AST (aspartate transaminase) and ALT (alanine transaminase) ≤ 3 x ULN; Total bilirubin ≤ 3 x ULN
Cardiac function
LVEF (left ventricular ejection fraction) ≥ 40% by electrocardiography
WBC < 25 x 10(9)/L on Day 1 prior to first dose of study drug; Platelet count > 10,000/mcL on Day 1 prior to first dose of study drug; AST (aspartate transaminase) and ALT (alanine transaminase) ≤ 3 x ULN (upper limit of normal); Total bilirubin ≤ 3 x ULN; Creatinine clearance (Cockcroft & Gault formula) ≥ 50 mL/min; LVEF (left ventricular ejection fraction) ≥ 40% by electrocardiography
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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