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FLT3-ITD Targeted Therapy in Fit AML Patients

NCT07425808 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 230

Last updated 2026-02-23

No results posted yet for this study

Summary

This international, multicenter, randomized (1:1), open-label phase II/III trial will evaluate the efficacy and safety of gilteritinib combined with azacitidine and venetoclax (experimental arm) versus standard "7+3" induction plus a FLT3inhibitor (quizartinib or midostaurin) (control arm) in newly diagnosed FLT3-ITD mutated AML patients eligible for intensive chemotherapy.

Conditions

  • AML (Acute Myeloid Leukemia)

Interventions

DRUG

Gilteritinib

Cycle 1: 80 mg once daily orally on days 1-28. Cycle 2 - 12: 80mg once daily orally on days 1-28. Cycle 13 - 24: gilteritinib 120 mg once daily orally on days 1-28. Following HSCT, maintenance with gilteritinib (120 mg once daily orally on days 1-28) will be offered for up to 36 cycles and started between day 30 and 90 after hematopoietic stem-cell transplantation (HSCT).

DRUG

Venetoclax

Cycle 1: ramp-up from 100mg on day 1, 200 mg on day 2 and 400 mg on days 3 - 28. Cycle 2 - 12: venetoclax 400 mg once daily orally days 1-7.

DRUG

Azacitidine (AZA)

Cycle 1: 75 mg/m² once daily subcutaneously on days 1-7. Cycle 2 -12: 75 mg/m² once daily subcutaneously on days 1-5. Cycle 13 - 24: 75 mg/m² once daily subcutaneously on days 1-5.

DRUG

Local standard of care (SOC)

Local SOC is "7+3" + Midostaurin (100 mg) or Quizartinib (35.4 mg)

Sponsors & Collaborators

  • Fondazione GIMEMA

    collaborator OTHER

  • Astellas Pharma Inc

    collaborator INDUSTRY

  • European Organisation for Research and Treatment of Cancer - EORTC

    lead NETWORK

Principal Investigators

  • Christoph Rummelt, MD, PhD · University Hospital Freiburg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-12-01
Primary Completion
2028-10-01
Completion
2032-02-01

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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 NCT07425808 on ClinicalTrials.gov