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A Study of Gilteritinib Versus Midostaurin in Combination With Induction and Consolidation Therapy Followed by One-year Maintenance in Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndromes With Excess Blasts-2 With FLT3 Mutations Eligible for Intensive Chemotherapy

NCT04027309 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 777

Last updated 2024-12-17

No results posted yet for this study

Summary

Activating mutations in the fms like tyrosine kinase 3 (FLT3) gene are observed in approximately 30% of patients with newly diagnosed acute myeloid leukemia (AML). Addition of the multitargeted kinase inhibitor midostaurin to standard chemotherapy prolongs event-free survival (EFS) and overall survival (OS) in patients with a FLT3 mutation. Gilteritinib is a more potent and more specific inhibitor of mutant FLT3 in comparison to midostaurin and has shown promising clinical activity in AML.

Conditions

Interventions

DRUG

Gilteritinib

Patients with a FLT3 mutation w ill be randomized to receive either the investigational drug gilteritinib or midostaurin given sequentially to standard induction and consolidation chemotherapy. After completing induction and consolidation treatment, patients who achieve CR/CRi/MLFS will receive maintenance therapy with gilteritinib or midostaurin

DRUG

Midostaurin

Patients with a FLT3 mutation w ill be randomized to receive either the investigational drug gilteritinib or midostaurin given sequentially to standard induction and consolidation chemotherapy. After completing induction and consolidation treatment, patients who achieve CR/CRi/MLFS will receive maintenance therapy with gilteritinib or midostaurin

Sponsors & Collaborators

  • Deutsch-Österreichische Studiengruppe Akute Myeloische Leukämie (AMLSG)

    collaborator UNKNOWN

  • Astellas Pharma Global Development, Inc.

    collaborator INDUSTRY

  • Stichting Hemato-Oncologie voor Volwassenen Nederland

    lead OTHER

Principal Investigators

  • M. Raaijmakers, Prof. Dr. · Erasmus MC / HOVON

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-20
Primary Completion
2025-10-31
Completion
2033-06-30

Countries

  • Australia
  • Austria
  • Belgium
  • Finland
  • France
  • Germany
  • Ireland
  • Lithuania
  • Netherlands
  • Norway
  • Spain
  • Sweden
  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

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 NCT04027309 on ClinicalTrials.gov