An open-label, single-arm, pilot study of Venetoclax in combination with 5 days Azacitidine in treatment-naïve subjects with acute myelogenous leukemia who are ≥18 years of age and not eligible for standard induction therapy (VENAZA-5S PILOT TRIAL)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-501537-23-00

Acronym

VENAZA-5S

Enrollment

Registered

2023-03-01

Start date

2023-05-16

Completion date

2025-11-16

Last updated

2025-05-07

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

The primary outcome measure is the response rate defined as the rate of CR or CRi after up to 6 cycles of therapy (best response).

Detailed description

Rate of CR or CRi by the Initiation of Cycle 2, Rate of CR with partial hematologic recovery (CRh) after up to 6 cycles of therapy, Time from initiation of treatment (C1D1) until achievement of CR or CRi, Objective response rate (CR, CRh, CRi, MLFS), Event free survival (EFS), Overall survival (OS), Descriptive assessment of MRD levels on study treatment, Time to treatment discontinuation, Rate of patients with at least one treatment interruption, Delay of subsequent cycles, dose reductions or shortening/interruption of study drug administration, Duration of patient hospitalization, Quality of life (QoL) measured through EORTC QLQ-C30

Interventions

DRUGVenclyxto 100 mg film-coated tablets

DRUGVidaza 25 mg/ml powder for suspension for injection

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary outcome measure is the response rate defined as the rate of CR or CRi after up to 6 cycles of therapy (best response).	—

Secondary

Measure	Time frame
Rate of CR or CRi by the Initiation of Cycle 2, Rate of CR with partial hematologic recovery (CRh) after up to 6 cycles of therapy, Time from initiation of treatment (C1D1) until achievement of CR or CRi, Objective response rate (CR, CRh, CRi, MLFS), Event free survival (EFS), Overall survival (OS), Descriptive assessment of MRD levels on study treatment, Time to treatment discontinuation, Rate of patients with at least one treatment interruption, Delay of subsequent cycles, dose reductions or shortening/interruption of study drug administration, Duration of patient hospitalization, Quality of life (QoL) measured through EORTC QLQ-C30	—

Measure

Time frame

—

Countries

Germany

Outcome results

None listed

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