OncoMatch/Clinical Trials/NCT06022003
Study Investigating the Efficacy and Safety of the Addition of Oral-azacitidine to Salvage Treatment by Gilteritinib in Subjects ≥18 Years of Age With Relapsed/Refractory FLT3-mutated Acute Myeloid Leukemia
Is NCT06022003 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including AzaCITIDine Oral Tablet and Xospata for aml, adult.
Treatment: AzaCITIDine Oral Tablet · Xospata — Approximately 30% of adult AML subjects are refractory to induction therapy. Furthermore, of those who achieve CR, approximately 75% will relapse. FLT3-mutated AML comprise an especially poor prognosis group. Until now, there was no established standard for relapsed subjects with FLT3 mutations and less than 20% will achieve CR with subsequent treatment. In phase 3 Study ADMIRAL Trial, gilteritinib has resulted in CRc in over 25% of subjects receiving 120 mg/day before on study HSCT. With this treatment, the median overall survival is at 9.3 months, furthermore, gilteritinib was well tolerated at the proposed doses. This study has been designed for R/R patients for which gilteritinib as single agent has been showed to be superior to high- and low-intensity chemotherapy (Perl, NEJM 2019, Supp Table S4) and patients included in this study will receive this treatment. Beyond high- or low-intensity chemotherapy, other options available are best supportive car or other clinical trials. The aim of this study is to assess the efficacy and safety of the addition of oral-azacitidine to salvage treatment by gilteritinib in subjects ≥18 years of age with relapsed/refractory FLT3-mutated acute myeloid leukemia
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Biomarker criteria
Required: FLT3 ITD (ITD/wt ratio > 0.05)
Presence of FLT3-mutation(s) at inclusion: in case of FLT3-ITD, the ITD/wt ratio must be > 0.05
Required: FLT3 TKD D835 (VAF > 5% by NGS)
in case of FLT3-TKD, the mutation must be at D835 or I836 position with a VAF > 5% by NGS
Required: FLT3 TKD I836 (VAF > 5% by NGS)
in case of FLT3-TKD, the mutation must be at D835 or I836 position with a VAF > 5% by NGS
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: intensive chemotherapy ("7+3", gemtuzumab ozogamycin, CPX-351, midostaurine) — 1st line
Subjects must be primary refractory or relapsed (R/R) to 1st line intensive chemotherapy (ICT) for AML
Cannot have received: oral azacitidine (oral azacitidine)
Patients who never received oral azacitidine
Cannot have received: gilteritinib (gilteritinib)
Subjects that have previously been treated by gilteritinib
Cannot have received: AZA as single agent (azacitidine)
Patients previously treated by AZA as single agent for AML are not allowed
Lab requirements
Kidney function
creatinine clearance ≥ 50 ml/min; calculated by the Cockcroft gault formula or measured by 24-hours urine collection
Liver function
AST ≤ 2.5 × ULN; ALT ≤ 2.5× ULN; bilirubin ≤ 1.5 × ULN
Cardiac function
LVEF ≥45%
adequate renal function as demonstrated by a creatinine clearance ≥ 50 ml/min; AST ≤ 2.5 × ULN; ALT ≤ 2.5× ULN; bilirubin ≤ 1.5 × ULN; adequate cardiac function with LVEF ≥45%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify