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 Venetoclax and a Hypomethylating Agent (RIVER-81)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-505911-19-00

Acronym

RIVER-81

Enrollment

129

Registered

2023-12-06

Start date

2024-01-05

Completion date

Unknown

Last updated

2025-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukemia

Brief summary

Part 1: Incidence and severity of AE, including events qualifying as DLTs, Part 2 and 3: CCR rate, including CR, CRh, CRi, with and without MRD (according to ELN 2022 [Döhner 2022])

Detailed description

All parts: Incidence and severity of AE, All parts: Transfusion independence, DoR, PFS, RFS, EFS, Overall survival, Percentage of participants bridged to HSCT, Part 1: PK of RVU120 including Cmax, tmax, AUCtau, and AUCinf, and t½, Part 2 and 3: Changes in patient-reported outcomes as assessed by changes in summary scores of the HM-PRO

Interventions

DRUGVENETOCLAX

DRUGSEL120 monohydrochloride

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Part 1: Incidence and severity of AE, including events qualifying as DLTs, Part 2 and 3: CCR rate, including CR, CRh, CRi, with and without MRD (according to ELN 2022 [Döhner 2022])	—

Secondary

Measure	Time frame
All parts: Incidence and severity of AE, All parts: Transfusion independence, DoR, PFS, RFS, EFS, Overall survival, Percentage of participants bridged to HSCT, Part 1: PK of RVU120 including Cmax, tmax, AUCtau, and AUCinf, and t½, Part 2 and 3: Changes in patient-reported outcomes as assessed by changes in summary scores of the HM-PRO	—

Countries

France, Italy, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026