FLT3-ITD Targeted Therapy in Fit AML Patients

Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Study ID
NCT07425808
Phase
PHASE2/PHASE3
Status
Not Yet Recruiting

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Conditions

  • AML (Acute Myeloid Leukemia)

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Gilteritinib — DRUG
    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).
  • Venetoclax — DRUG
    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.
  • Azacitidine (AZA) — DRUG
    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.
  • Local standard of care (SOC) — DRUG
    Local SOC is "7+3" + Midostaurin (100 mg) or Quizartinib (35.4 mg)

Study Details

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.

Key Dates

Start date
Dec 1, 2026
Status verified
Feb 2026
Primary completion
Oct 1, 2028
Completion
Feb 1, 2032

Study Design

Enrollment
230 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Triplet combination of venetoclax, azacitidine and gilteritinib
    Triplet regimen consisting of venetoclax, azacitidine and gilteritinib, administered for up to 12 cycles (28-day cycles). This will be followed by up to 12 additional cycles of azacitidine in combination with gilteritinib (28-day cycles).
  • Active Comparator: Local standard of care
    Local standard of care, consisting of induction with '7+3', consolidation with high-dose cytarabine, and maintenance with a FLT3 inhibitor (midostaurin, quizartinib, or sorafenib) as per local practice.

Primary Outcome Measure

Phase II: Achievement of CR/CRi documented within 6 months from randomization, occurring prior to allografting and before initiation of any post-protocol treatments. [ Time Frame: Within 6 months from randomization ]

Central Contacts

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