A Randomized Phase 2/3 Study Evaluating the Safety and Efficacy of Pivekimab Sunirine (PVEK) in Combination with Venetoclax and Azacitidine in Adult Subjects with Newly Diagnosed Acute Myeloid Leukemia (AML) Ineligible to Receive Intensive Chemotherapy

Status

Not yet recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-523724-47-00

Enrollment

Registered

2026-08-03

Start date

Unknown

Completion date

Unknown

Last updated

2026-08-03

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

Phase 2: Complete remission (CR), Phase 3: Complete remission (CR), Phase 3: Overall Survival (OS), Number of Participants with Adverse Events (AEs)

Detailed description

Phase 2 and Phase 3: Composite Response, Phase 2 and Phase 3: Duration of CR (DoCR), Phase 2: Change from baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORCT QLQ-C30) domains, Phase 3: Percentage of Participants with Transfusion Independence, Phase 3: Conversion from baseline transfusion dependence to post-baseline transfusion independence, Phase 3: Change from baseline in the EORCT QLQ-C30 physical functioning domains, Phase 3: Change from baseline in the remaining EORCT QLQ-C30 domains, Phase 3: Change from Baseline in European Quality of Life 5 Dimensions (EQ-5D-5L) Utility Index and Visual Analog Scale (VAS) scores, Phase 3: Change from Baseline to the responses to FACT GP5

Interventions

DRUGVenetoclax

DRUGPIVEKIMAB SUNIRINE

DRUGAZACITIDINE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Phase 2: Complete remission (CR), Phase 3: Complete remission (CR), Phase 3: Overall Survival (OS), Number of Participants with Adverse Events (AEs)	—

Secondary

Measure	Time frame
Phase 2 and Phase 3: Composite Response, Phase 2 and Phase 3: Duration of CR (DoCR), Phase 2: Change from baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORCT QLQ-C30) domains, Phase 3: Percentage of Participants with Transfusion Independence, Phase 3: Conversion from baseline transfusion dependence to post-baseline transfusion independence, Phase 3: Change from baseline in the EORCT QLQ-C30 physical functioning domains, Phase 3: Change from baseline in the remaining EORCT QLQ-C30 domains, Phase 3: Change from Baseline in European Quality of Life 5 Dimensions (EQ-5D-5L) Utility Index and Visual Analog Scale (VAS) scores, Phase 3: Change from Baseline to the responses to FACT GP5	—

Measure

Time frame

—

Outcome results

None listed

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