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A Phase 2 Study of Gemtuzumab Ozogamicin (GO)-Gilteritinib Combination in Adults With FLT3-ITD and/or FLT3-TKD Relapse/Refractory (R/R) AML

NCT05199051 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2026-01-05

No results posted yet for this study

Summary

This is a national, open-label, single-arm, multicenter phase II trial evaluating the safety and efficacy of adding gilteritinib, a new FLT3 inhibitor to the AGORA platform, consisting of the combination of an intermediate dose of cytarabine and a divided dose of GO in adult patients with R / R AML with an FLT3-ITD and/or FLT3-TKD mutation.

Conditions

  • AML
  • Leukaemia (Acute Myeloid)

Interventions

COMBINATION_PRODUCT

Gemtuzumab ozogamicine - Cytarabine - Gilteritinib

See Arms description paragraph

Sponsors & Collaborators

  • Astellas Pharma Inc

    collaborator INDUSTRY

  • Pfizer

    collaborator INDUSTRY

  • Acute Leukemia French Association

    collaborator OTHER

  • Centre Antoine Lacassagne

    lead OTHER

Principal Investigators

  • Juliette LAMBERT, MD-PHD · Versailles Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-03
Primary Completion
2028-07-10
Completion
2028-07-10

Countries

  • France

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05199051 on ClinicalTrials.gov