🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the EU / 2025-521390-14-00
Ongoing Phase II

Revumenib Treatment in Combination with FLA Chemotherapy in Paediatric Refractory/Relapsed KMT2A-r, NUP98-r or NPM1-mut Acute Myeloid Leukemia (AML)

2025-521390-14-00 · tracked via the Priya Life Science EU tracker
Sponsor
Pediatric Research International GmbH
Sponsor type
Patient organisation/association
Therapeutic area
Neoplasms
Decision date
16/02/2026
Enrollment target
31
Sites
Denmark, Italy, Czechia, Sweden, Poland, Netherlands, Germany, Austria

Condition studied

Acute Myeloid Leukemia

Investigational medicinal product(s)

RevumenibCYTARABINERevumenibRevumenibFLUDARABINERevumenib

Eligibility

Age group
18-64 years, 0-17 years
Sex
Female, Male

Primary endpoint

The primary efficacy endpoint of Part I in this study is to estimate the ORR. We will compare the ORR to a historically informed null ORR rate of 37% after up to 2 cycles with revumenib in combination with FLA in R/R KMT2A-r, NUP98-r or NPM1- mut AML.

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 2025-521390-14-00 on CTIS ↗ ← All trials in the EU