Trial intelligence / Profile preview

Venetoclax or Gilteritinib with Intensive Chemotherapy in Young Newly Diagnosed AML

NCT06652685Phase 2

Key facts

Status
Not yet recruiting
Start
Oct 2024
Primary completion
Oct 2026
Countries
1
Sponsor
Ruijin Hospital
Modality
Fragment-Derived Small Molecules, Allosteric Modulators, Orthosteric Ligands
Conditions
acute myeloid leukemia (AML)
01

Overview

Phase 2, open-label trial of venetoclax and gilteritinib in acute myeloid leukemia (AML) (2 arms), sponsored by Ruijin Hospital. Primary endpoint: Composite Complete Remission Rate. Planned start Oct 2024; status: not yet recruiting.

02

Design

2 arms
Study design
Non-randomizedOpen-label
  • D5-PBCR(-) IA arm

    Standard IA induction for early responders

  • D5-PBCR(+) IA+Venetoclax arm

    IA + Venetoclax for early non-responders

03

Who it enrols

Young patients (18-59) with newly diagnosed AML (excluding APL and CBF-AML) and adequate organ function.

04

Endpoints

Primary

  • Composite Complete Remission Rate

Secondary

  • Total Composite Complete Remission Rate

  • Overall Survival

  • Event-Free Survival

  • Adverse Events

  • Recovery Time for Neutrophils and Platelets

Beyond the preview

Go deeper on NCT06652685.

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 NCT06652685.

Gosset Free

Get started with Gosset.

Enter your corporate email.

Work email preferred.

Book a call