Trial intelligence / Profile preview

TAGALONG: Tagraxofusp, Azacitidine, and Venetoclax in Newly Diagnosed Secondary AML

NCT05442216Phase 2

Key facts

Status: Recruiting
Start: May 2024
Primary completion: Jul 2030
Countries: 1
Modality: Immunotoxins, Fc-Fusion Proteins

Drugs: tagraxofusp
Conditions: acute myeloid leukemia (AML)

Overview

Phase 2, open-label, single-arm trial of tagraxofusp in acute myeloid leukemia (AML). Primary endpoint: Complete Response at 5 years. Started May 2024; status: recruiting.

Design

1 arm

Study design: Non-randomizedOpen-labelSingle group

Experimental Group
Tagraxofusp + Azacitidine + Venetoclax

Who it enrols

Adults with newly diagnosed, untreated secondary AML (>=20% blasts) with documented CD123 positivity, prior history of MDS/CMML/MPN, and prior treatment with at least 2 cycles of hypomethylating agents. Must have adequate organ function, LVEF >= 45%, and WBC < 30 x 10^9/uL. Excludes patients suitable for intensive chemotherapy, with APL, CNS involvement, or prior tagraxofusp.

Endpoints

Primary

Complete Response5 years

Secondary

Adverse Events4 months
Complete Response plus Complete Response with partial hematologic recovery5 years
Complete Response without Minimal Residual Disease5 years
Overall Response Rate5 years
Overall Survival5 years
Disease Free Survival5 years
Recurrence Free Survival5 years
Event-Free Survival5 years

Beyond the preview

Go deeper on NCT05442216.

Full results, competitive context and analysis are in the Gosset platform.

Full results & analysis

Available in the Gosset platform where reported.

Competitive context

Available in the Gosset platform where reported.

Bring the full picture into focus.

See how Gosset can support your research on NCT05442216.