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Clinical Trials in the EU / 2025-523238-17-00
Ongoing Phase II

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

2025-523238-17-00 · tracked via the Priya Life Science EU tracker
Sponsor
Fundacion PETHEMA
Sponsor type
Patient organisation/association
Therapeutic area
Neoplasms
Decision date
19/02/2026
Enrollment target
62
Sites
Spain, Portugal

Condition studied

Acute myeloid leukemia

Investigational medicinal product(s)

Inaqovi 35 mg/100 mg film-coated tabletsTibsovo 250 mg film-coated tablets

Eligibility

Age group
18-64 years, 65+ years
Sex
Female, Male

Primary endpoint

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

Endpoint detail

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

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2025-523238-17-00 on CTIS ↗ ← All trials in the EU