Actively Recruiting
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
Led by French Innovative Leukemia Organisation · Updated on 2025-03-24
33
Participants Needed
20
Research Sites
193 weeks
Total Duration
On this page
Sponsors
F
French Innovative Leukemia Organisation
Lead Sponsor
A
Acute Leukemia French Association
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of acute myeloid leukemia (AML) according to WHO 2016 classification
- Presence of FLT3 mutation: ITD ratio > 0.05 or TKD mutation at D835 or I836 with VAF > 5%
- Relapsed or refractory to first-line intensive chemotherapy for AML
- No prior treatment with oral azacitidine
- Age 18 years or older
- Adequate organ function: creatinine clearance ≥ 50 ml/min, AST and ALT ≤ 2.5× ULN, bilirubin ≤ 1.5× ULN
- Adequate cardiac function with LVEF ≥ 45%
- ECOG performance status less than 3
- No psychological, familial, sociological, or geographical issues affecting study compliance
- Suitable for oral drug administration
- Female participants must not be pregnant and follow contraception guidelines
- Affiliation to French social security
- Signed informed consent
- Agreement to avoid breastfeeding and donating ova or sperm during and after study as specified
You will not qualify if you...
- AML secondary to prior myeloproliferative syndrome (MPN), acute promyelocytic leukemia (APL), core binding factor AML, DNA fragility or bone marrow failure syndromes, blastic plasmacytoid dendritic cell neoplasm, or acute lymphoblastic leukemia
- Patients on third or later line of treatment
- Prior treatment with azacitidine as single agent or gilteritinib
- Active central nervous system (CNS) leukemia
- More than one prior allogeneic hematopoietic stem cell transplant (HSCT)
- Relapse within 100 days after allogeneic HSCT
- Grade 2 or higher graft-versus-host disease (GVHD) or recent therapy escalation for GVHD
- Use of strong CYP3A inducers or inhibitors as concomitant drugs
- Severe liver disease
- Significant coagulation abnormalities
- Uncontrolled systemic infection
- Isolated extramedullary leukemia relapse
- History of other malignancies within past 3 years except certain skin or cervical cancers
- Serious medical, psychiatric, or laboratory conditions increasing risk or preventing consent
- Severe medical or mental conditions precluding protocol treatment
- Legal or psychiatric restrictions on liberty
- Comorbidities incompatible with intensive chemotherapy
- Positive HIV test or active hepatitis B or C infection
- Known hypersensitivity to study medications
- Congestive heart failure NYHA class III or IV unless LVEF ≥ 45%
- QTcF interval > 450 ms or history of Long QT Syndrome
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 20 locations
1
Amiens CHU
Amiens, France
Not Yet Recruiting
2
Angers CHU
Angers, France
Actively Recruiting
3
Hôpital d'Instruction des Armées PERCY
Clamart, France
Not Yet Recruiting
4
CHU Estaing
Clermont-Ferrand, France
Active, Not Recruiting
5
Créteil CHU HENRI MONDOR
Créteil, France
Not Yet Recruiting
6
Grenoble CHU
Grenoble, France
Actively Recruiting
7
CHU Lille
Lille, France
Not Yet Recruiting
8
Limoges CHU
Limoges, France
Not Yet Recruiting
9
Lyon sud CHU
Lyon, France
Not Yet Recruiting
10
Marseille IPC
Marseille, France
Active, Not Recruiting
11
Nantes CHU
Nantes, France
Active, Not Recruiting
12
Centre Antoine Lacassagne
Nice, France
Suspended
13
Paris Saint Louis
Paris, France
Not Yet Recruiting
14
Bordeaux CHU
Pessac, France
Actively Recruiting
15
Rennes CHU
Rennes, France
Not Yet Recruiting
16
Centre de Lutte Contre le Cancer H. Becquerel
Rouen, France
Not Yet Recruiting
17
ICANS - Institut de cancérologie de strasbourg europe
Strasbourg, France
Not Yet Recruiting
18
Toulouse - IUCT Oncopole - Service d'Hématologie
Toulouse, France
Active, Not Recruiting
19
Nancy CHU
Vandœuvre-lès-Nancy, France
Not Yet Recruiting
20
Versailles CH
Versailles, France
Not Yet Recruiting
Research Team
P
Pierre-Yves DUMAS, MD, PhD
CONTACT
A
Ariane MINEUR
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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