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Tests treatment safety and results for AML, Adult
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
ClinicalTrials.gov ID: NCT06022003
What this study is testing
What is AzaCITIDine Oral Tablet?
AzaCITIDine Oral Tablet is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for aml, adult.
Also referred to as Onureg, CC-486.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Approximately 30% of adult AML subjects are refractory to induction therapy. Furthermore, of those who achieve CR, approximately 75% will relapse.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Confirmed diagnosis of acute myeloid leukemia (AML) according to world health organization (WHO) 2016 classification
- Presence of FLT3-mutation(s) at inclusion: in case of FLT3-ITD, the ITD/wt ratio must be \> 0.05 ; in case of FLT3-TKD, the mutation must be at D835...
- people must be primary refractory or relapsed (R/R) to 1st line intensive chemotherapy (ICT) for AML. Hydroxyurea is allowed for the control of...
- adequate renal function as demonstrated by a creatinine clearance ≥ 50 ml/min; calculated by the Cockcroft gault formula or measured by 24-hours...
- aspartate aminotransferase (AST) ≤ 2.5 × ULN
You likely can't join if
- 1\. people with any of the following current or previous diagnoses:
- 1a. AML secondary to prior myeloproliferative syndrome (MPN)
- 1b. Acute promyelocytic leukemia (APL) and core binding factor (CBF) AML
- 1c. DNA fragility or bone marrow (BM) failure syndromes
- 1d. Blastic plasmacytoid dendritic cell neoplasm
- 1e. Acute lymphoblastic leukemia including ambiguous lineage 2. Patients ≥ 3rd line of treatment, HSCT being not considered as a line of treatment 3...
See the full eligibility criteria
- Confirmed diagnosis of acute myeloid leukemia (AML) according to world health organization (WHO) 2016 classification
- Presence of FLT3-mutation(s) at inclusion: in case of FLT3-ITD, the ITD/wt ratio must be \> 0.05 ; in case of FLT3-TKD, the mutation must be at D835 or I836 position with a VAF \> 5% by NGS.
- people must be primary refractory or relapsed (R/R) to 1st line intensive chemotherapy (ICT) for AML. Hydroxyurea is allowed for the control of peripheral leukemic blasts in patients with leukocytosis. 3a. Primary...
- adequate renal function as demonstrated by a creatinine clearance ≥ 50 ml/min; calculated by the Cockcroft gault formula or measured by 24-hours urine collection
- aspartate aminotransferase (AST) ≤ 2.5 × ULN
- alanine aminotransferase (ALT) ≤ 2.5× ULN
- bilirubin ≤ 1.5 × ULN
- adequate cardiac function with LVEF ≥45% 8. ECOG \< 3 (appendix 1) 9. Absence of any psychological, familial, sociological, or geographical conditions potentially hampering compliance with the study protocol and...
- 1\. people with any of the following current or previous diagnoses:
- 1a. AML secondary to prior myeloproliferative syndrome (MPN)
- 1b. Acute promyelocytic leukemia (APL) and core binding factor (CBF) AML
- 1c. DNA fragility or bone marrow (BM) failure syndromes
- 1d. Blastic plasmacytoid dendritic cell neoplasm
- 1e. Acute lymphoblastic leukemia including ambiguous lineage 2. Patients ≥ 3rd line of treatment, HSCT being not considered as a line of treatment 3. Patients previously treated by AZA as single agent for AML are not...
- 14\. Subject exhibiting evidence of other clinically significant uncontrolled systemic infection requiring therapy (viral, bacterial, or fungal).
- 15\. Isolated extramedullary leukemia relapse 16. History of another malignancy within the past 3 years except basal cell carcinoma of the skin or cervix in situ carcinoma 17. Any other serious medical condition...
The study team makes the final eligibility decision.
Where it's taking place
- Amiens, France
- Angers, France
- Clamart, France
- Clermont-Ferrand, France
- Créteil, France
- Grenoble, France
- Lille, France
- Limoges, France
- Lyon, France
- Marseille, France
- Nantes, France
- Nice, France
- Paris, France
- Pessac, France
- Rennes, France
- Rouen, France
- Strasbourg, France
- Toulouse, France
- Vandœuvre-lès-Nancy, France
- Versailles, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amiens, France; Angers, France; Clamart, France; Clermont-Ferrand, France; Créteil, France; Grenoble, France and 14 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.