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

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-521390-14-00
Enrollment
2
Registered
2026-02-16
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-16

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 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.

Interventions

DRUGRevumenib
DRUGFLUDARABINE
DRUGCYTARABINE

Sponsors

GPHS Deutsche Paediatrisch-haematologische Studiengesellschaft mbH
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
0 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
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.—

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 17, 2026