Prospective evaluation of response to treatment by analysis of measurable residual disease in younger adult patients (18-60 years) with acute myeloid leukemia (AML). The Backbone InterGroup (BIG)-2 umbrella trial from the Acute Leukemia French Intergroup (ALFA, FILO) - BIG-2

Conditions

Acute Myeloid Leukemia

Brief summary

Sub-study 1 (FLT3-ITD+ without CBF, comparative): Achieving CR/CRh/CRi without MRD after one cycle of combined 7+3 induction chemotherapy with Quizartinib or Midostaurin, as assessed by FLT3-ITD PCR-NGS in BM, where MRD negativity threshold level is defined as < 0.01% Variant Allele Frequency (VAF) according to the 2025 revised ELN-DAVID AML MRD recommendations., Sub-study 2 (FLT3-ITD- salvage, comparative): Achieving CR/CRh/CRi without MRD after second chemotherapy cycle with HDAC plus Venetoclax or HDAC alone, as assessed by MFC in BM using LAIP-DfN method, where MRD negativity threshold level is defined as < 0.1% of CD45 expressing cells with the target immunophenotype according to the 2021 revised ELN-DAVID AML MRD recommendations., Sub-study 3 (FLT3-ITD- responders, exploratory): OS time from initiation of consolidation therapy defined as the time (in months) elapsed from the date of first consolidation administration up to the date of death regardless of the cause.

Related papers

No related papers found yet.

Interventions

DRUGVANFLYTA 26.5 mg film-coated tablets

DRUGDEXAMETHASONE VIATRIS 20 mg/5 ml

DRUGsolution injectable en ampoule

DRUGCerubidin 20 mg pulver til infusjonsvæske

DRUGoppløsning

DRUGCytarabine 100 mg/ml Injection

DRUGAzacitidine Mylan 25 mg/mL powder for suspension for injection

DRUGVenclyxto 100 mg film-coated tablets

DRUGRydapt 25 mg soft capsules

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Sub-study 1 (FLT3-ITD+ without CBF, comparative): Achieving CR/CRh/CRi without MRD after one cycle of combined 7+3 induction chemotherapy with Quizartinib or Midostaurin, as assessed by FLT3-ITD PCR-NGS in BM, where MRD negativity threshold level is defined as < 0.01% Variant Allele Frequency (VAF) according to the 2025 revised ELN-DAVID AML MRD recommendations., Sub-study 2 (FLT3-ITD- salvage, comparative): Achieving CR/CRh/CRi without MRD after second chemotherapy cycle with HDAC plus Venetoclax or HDAC alone, as assessed by MFC in BM using LAIP-DfN method, where MRD negativity threshold level is defined as < 0.1% of CD45 expressing cells with the target immunophenotype according to the 2021 revised ELN-DAVID AML MRD recommendations., Sub-study 3 (FLT3-ITD- responders, exploratory): OS time from initiation of consolidation therapy defined as the time (in months) elapsed from the date of first consolidation administration up to the date of death regardless of the cause.	—

Measure

Time frame

Sub-study 1 (FLT3-ITD+ without CBF, comparative): Achieving CR/CRh/CRi without MRD after one cycle of combined 7+3 induction chemotherapy with Quizartinib or Midostaurin, as assessed by FLT3-ITD PCR-NGS in BM, where MRD negativity threshold level is defined as < 0.01% Variant Allele Frequency (VAF) according to the 2025 revised ELN-DAVID AML MRD recommendations., Sub-study 2 (FLT3-ITD- salvage, comparative): Achieving CR/CRh/CRi without MRD after second chemotherapy cycle with HDAC plus Venetoclax or HDAC alone, as assessed by MFC in BM using LAIP-DfN method, where MRD negativity threshold level is defined as < 0.1% of CD45 expressing cells with the target immunophenotype according to the 2021 revised ELN-DAVID AML MRD recommendations., Sub-study 3 (FLT3-ITD- responders, exploratory): OS time from initiation of consolidation therapy defined as the time (in months) elapsed from the date of first consolidation administration up to the date of death regardless of the cause.

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Outcome results

None listed