The Efficacy of Triple Regimen in Newly Diagnosed AML Patients With FLT3 Mutation

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age14+
SponsorInstitute of Hematology & Blood Diseases Hospital, China

About this trial

The FMS tyrosine kinase 3 (FLT3) gene mutation occurs in 30% of newly diagnosed AML patients, leading to a higher relapse rate and mortality rate. In the past, multi-drug combination chemotherapy regimens had limited efficacy in newly diagnosed AML patients with FLT3 mutations, especially in those with FLT3-ITD. However, the FLT3 inhibitors greatly improved the survival of AML patients with FLT3 mutations. Although several studies have focused on the effectiveness of FLT3 inhibitor combination therapy for FLT3-mutated AML, further studies are needed to determine the optimal regimen and dosage. A triple regimen consisting of Gilteritinib, Venetoclax, and Azacitidine had shown good efficacy in unfit newly diagnosed FLT3-mutated AML patients. This clinical trial aims to determine the optimal triple regimen and investigate its efficacy in newly diagnosed fit FLT3-mutated AML patients.

Eligibility criteria

Qualifiers

MDS/AML patients WHO meet AML and ICC definitions according to WHO (2022) or ICC standards (10%-20% of bone marrow naive cells) and have FLT3-TKD or ITD mutations detected by PCR or second-generation sequencing.

Age ≥15 years old, male or female.

The physical status assessment (ECOG-PS) of the Eastern Oncology Collaboration group was 0-2 points.

Disqualifiers

Acute promyelocytic leukemia with PML-RARA fusion gene

Acute myeloid leukemia with RUNX1-RUNX1T1 or CBFB-MYH11 fusion gene

Acute myeloid leukemia with BCR-ABL fusion gene

Have treated patients (those who have previously received induction chemotherapy but can receive hydroxyurea down-cell therapy).

Trial design

Treatments tested in this trial

  • Venetoclax
  • Cytarabine
  • Gilteritinib
  • Azacitadine (AZA)

Treatment groups

66 Participants
are divided into 3 treatment groups