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A Randomized, Open-label, Controlled, Phase 2 Study of Pevonedistat, Venetoclax, and Azacitidine Versus Venetoclax Plus Azacitidine in Adults With Newly Diagnosed Acute Myeloid Leukemia Who Are Unfit for Intensive Chemotherapy Triple Combination of Pevonedistat and Venetoclax Plus Azacitidine in Adults With Acute Myeloid Leukemia Who Are Unfit for Intensive Chemotherapy

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-515424-36-00
Acronym
Pevonedistat-2002
Enrollment
2
Registered
2024-10-09
Start date
2020-10-15
Completion date
2025-10-06
Last updated
2025-06-24

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 endpoint of the study is EFS defined as failure to achieve CR/CRi, relapse from CR/CRi, or death.

Detailed description

The key secondary endpoint is OS (Overall Survival) defined as the time from randomization to death from any cause., 30- and 60-day mortality rates defined as the proportion of patients who survive at most 30/60 days from the first dose of study drug(s)., Disease response rates as evaluated by IRC: – CR rate – CCR (CR + CRi) rate – ORR (CR + CRi + PR) rate – CR + CRh rate – Leukemia response rate (CR + CRi + PR + MLFS [marrow CR]), Duration of CR and CRi. • Time to first CR, CRi, and PR. • Pevonedistat plasma concentration time.

Interventions

DRUGVidaza 25 mg/ml powder for suspension for injection
DRUGAzacitidin STADA 25 mg/ml Pulver zur Herstellung einer Injektionssuspension
DRUGVenclyxto 10 mg film-coated tablets
DRUGVenclyxto 50 mg film-coated tablets
DRUGAzacitidine Mylan 25 mg/mL powder for suspension for injection
DRUGpevonedistat hydrochloride
DRUGVenclyxto 100 mg film-coated tablets

Sponsors

Takeda Development Center Americas Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The primary endpoint of the study is EFS defined as failure to achieve CR/CRi, relapse from CR/CRi, or death.—

Secondary

MeasureTime frame
The key secondary endpoint is OS (Overall Survival) defined as the time from randomization to death from any cause., 30- and 60-day mortality rates defined as the proportion of patients who survive at most 30/60 days from the first dose of study drug(s)., Disease response rates as evaluated by IRC: – CR rate – CCR (CR + CRi) rate – ORR (CR + CRi + PR) rate – CR + CRh rate – Leukemia response rate (CR + CRi + PR + MLFS [marrow CR]), Duration of CR and CRi. • Time to first CR, CRi, and PR. • Pevonedistat plasma concentration time.—

Countries

Italy, Poland

Outcome results

None listed

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