Actively Recruiting
Open-label Phase 2 Study of Oral-azacitidine Added to Salvage Treatment with Gilteritinib in Adults 6 Years with Relapsed or Refractory FLT3-mutated Acute Myeloid Leukemia
Led by French Innovative Leukemia Organisation · Updated on 2025-03-24
33
Participants Needed
20
Research Sites
52 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
Researchers are studying adults with relapsed or refractory FLT3-mutated acute myeloid leukemia (AML), a type of blood cancer with poor prognosis and high relapse rates. The study aims to assess whether adding oral azacitidine to the salvage treatment with gilteritinib improves treatment outcomes. This phase 2, open-label trial focuses on patients who have not responded to or have relapsed after first-line intensive chemotherapy and have specific FLT3 gene mutations. Participants receive a combination of gilteritinib (120 mg daily) and oral azacitidine (300 mg daily on days 1 to 14 of a 28-day cycle). Gilteritinib is an approved treatment for this condition, and oral azacitidine is being studied as an addition to enhance efficacy. The study uses continuous 28-day treatment cycles and monitors responses over at least three months, with follow-up extending throughout the treatment period. During the study, participants will be closely monitored for treatment response, including rates of complete remission and remission with incomplete blood count recovery. Safety is assessed by tracking adverse events and early deaths. Regular evaluations include laboratory tests, organ function assessments, and quality of life measures. The primary outcome is the rate of composite complete remission within the first three months of treatment, with secondary outcomes focusing on safety and detailed remission rates over six months. Total participation time varies based on treatment duration and response.
CONDITIONS
Brief 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) as per WHO 2016 classification
- Presence of FLT3 mutation (FLT3-ITD with ITD/wt ratio > 0.05 or FLT3-TKD mutation at D835 or I836 with VAF > 5%)
- Primary refractory or relapsed after first-line intensive chemotherapy for AML
- Age 18 years or older
- Adequate kidney function (creatinine clearance 250 ml/min)
- Liver enzymes AST and ALT 2.5 times upper limit of normal
- Bilirubin 1.5 times upper limit of normal
- Adequate heart function with left ventricular ejection fraction 245%
- ECOG performance status less than 3
- Ability to comply with study protocol and follow-up
- Suitable for oral drug administration
- Women must not be pregnant and must follow specified contraception and breastfeeding restrictions
- Affiliation to French social security (health insurance)
- Signed informed consent
You will not qualify if you...
- AML secondary to prior myeloproliferative syndrome or specific subtypes like acute promyelocytic leukemia
- Acute lymphoblastic leukemia or ambiguous lineage leukemia
- Patients with more than two prior lines of treatment
- Prior treatment with gilteritinib or oral azacitidine
- Active central nervous system leukemia
- More than one prior allogeneic hematopoietic stem cell transplant or relapse within 100 days of transplant
- Grade 2 or higher graft-versus-host disease or recent escalation of GVHD therapy
- Use of strong CYP3A inducers or P-gp inhibitors unless essential
- Severe liver disease or abnormal coagulation
- Clinically significant uncontrolled infections
- Isolated extramedullary leukemia relapse
- Recent other malignancies except specific skin or cervical cancers
- Serious medical, psychiatric conditions, or HIV infection
- Known hypersensitivity to study drugs
- Congestive heart failure NYHA class III or IV unless LVEF 245%
- QTcF interval > 450 ms or history of Long QT Syndrome at screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months or until treatment discontinuation
Participants receive oral gilteritinib daily in 28-day cycles combined with oral azacitidine daily on Days 1 to 14 of each 28-day cycle as treatment for relapsed or refractory FLT3-mutated acute myeloid leukemia.
Monthly visits during treatment cycles
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
A
Ariane MINEUR
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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