A Phase 1/2 Study to Assess the Safety, Pharmacokinetics, and Efficacy of Daily Intravenous of AB8939 in patients with Relapsed/Refractory Acute Myeloid Leukemia

Status

Not yet recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-516641-39-00

Acronym

AB18001

Enrollment

Registered

2024-12-02

Start date

Unknown

Completion date

Unknown

Last updated

2025-06-16

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

Rate of dose-limiting toxicity (DLT)

Detailed description

Rate and duration of composite response rate (CRc) is defined as CRc = CR + CRh + CRi + CRp, Rate of ORR, PK parameters: Tmax, Cmax, AUC0-t, AUC0-inf, t1/2, Cl, Vd, after the first administration for all patients, Response rate based on the subtype of leukemia, risk-status, and genetic abnormalities

Interventions

DRUGVenclyxto 100 mg film-coated tablets

DRUGVidaza 25 mg/ml powder for suspension for injection

DRUGAB8939

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Rate of dose-limiting toxicity (DLT)	—

Secondary

Measure	Time frame
Rate and duration of composite response rate (CRc) is defined as CRc = CR + CRh + CRi + CRp, Rate of ORR, PK parameters: Tmax, Cmax, AUC0-t, AUC0-inf, t1/2, Cl, Vd, after the first administration for all patients, Response rate based on the subtype of leukemia, risk-status, and genetic abnormalities	—

Countries

France, Germany, Greece, Spain

Outcome results

None listed

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