A phase II, multicentre, open label clinical trial evaluating the efficacy and safety of oral decitabine plus ivosidenib in adult patients with newly diagnosed acute myeloid leukemia older than 60 years old and/or who are ineligible for standard induction chemotherapy

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-523238-17-00

Enrollment

Registered

2026-02-19

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-19

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

Complete response (CR)/Immunophenotipic complete response (CRi), Safety

Detailed description

Overall survival (OS), Event-free survival (EFS)

Interventions

DRUGTibsovo 250 mg film-coated tablets

DRUGInaqovi 35 mg/100 mg film-coated tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Complete response (CR)/Immunophenotipic complete response (CRi), Safety	—

Secondary

Measure	Time frame
Overall survival (OS), Event-free survival (EFS)	—

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 20, 2026