Detail Article

Informations générales (source: ClinicalTrials.gov)

Numéro NCT

NCT04777916 En recrutement IDF

Titre

A Prospective Non-interventional Study Documenting the Management and Outcomes of Adult Patients With Acute Myeloid Leukemia (AML)

Type

Observational [Patient Registry]

Pathologie

Leucémies
Leucémie myéloïde
Leucémie aigüe myéloïde

Phase

Promoteur

Acute Leukemia French Association (Voir sur ClinicalTrials)

Date de début

avril 2022

Date de fin

avril 2046

Dernière mise à jour

02 novembre 2025

Résumé

During the last fifteen years, the landscape of AML diagnosis and therapeutical options has markedly evolved. Refined genetic and prognostic characterizations, together with new drug approvals and new allogeneic hematopoietic stem cell transplantation (HSCT) procedures, have increased patient journey diversity.

Détail

Voir le détail During the last fifteen years, the landscape of AML diagnosis and therapeutical options has markedly evolved. Refined genetic and prognostic characterizations, together with new drug approvals and new allogeneic hematopoietic stem cell transplantation (HSCT) procedures, have increased patient journey diversity. I - At initial AML diagnosis, not all newly diagnosed patients are entering clinical trials. A substantial proportion of them are treated with standard therapies outside of any trial. To date, the standard approved frontline treatment options include: 1. Standard intensive 3+7 (anthracycline + cytarabine) chemotherapy ± an approved FLT3 inhibitor (midostaurine, Rydapt®), or ± quizartinib (Vanflyta®) according to different dose schedules in older versus younger patients 2. Combination of sequential gemtuzumab ozogamicin (GO, Mylotarg®) with 3+7 3. Liposomal formulation of daunorubicin + cytarabine (CPX-351, Vyxeos®) 4. Less intensive chemotherapy with azacytidine or low dose cytarabine (LDAC) in patients considered as not eligible for the more intensive options above The investigator's choice is guided by AML and patient's characteristics, and by the approved indications for each of these treatment options. This study will thus start including these specific options. Further study amendments might be necessary in case of new standard treatment definition. II - Secondly, no specific salvage regimen has emerged as a standard in patients with primary refractory or relapsed AML (R/R AML). R/R AML is thus an important field for investigational new drugs (INDs) and precision medicine development. To date, the only IND approved to treat R/R AML is gilteritinib for FLT3-mutated AML patients. The French agency ANSM also allow to use GO for treating R/R AML patients in the frame of a RTU (Recommendation Temporaire d'Utilisation). In the "real life", because of the multiplicity of treatments used in these patients, some of them being now quite efficient, it has become difficult to accurately describe the general outcome of R/R AML patients. III - Thirdly, allogeneic HSCT is no more considered at the ultimate and final goal of AML therapy in all patients, as it was in the past. Transplant indications have been better described and HSCT in now evaluated in the context of the whole treatment course, including pre- and post-transplant therapy, as well as pre- and post-transplant minimal residual disease (MRD) levels. For all these reasons, it is of utmost importance to document the various characteristics, treatments and outcomes of patients treated in the real-life, outside of clinical trials, for 1) real-world treatment evaluation; 2) post-approval use of recently approved drugs; 3) standardization and improvement of routine patient management; and 4) better disease understanding. Fermer le détail

Etablissements

Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données
CLCC INSTITUT GUSTAVE ROUSSY	Jean-Baptiste MICOL	Recrutement non commencé	20/06/2024 12:17:03	Contacter
HOPITAL NOVO	VAIDA	En recrutement IDF	18/09/2025 17:50:04	Contacter
Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
AP-HP - Hôpital Avicenne	Thorsten BRAUN, MD-Prof			Contact (sur clinicalTrials)
AP-HP - Hôpital Necker-Enfants Malades	Ambroise MARCAIS, MD			Contact (sur clinicalTrials)
AP-HP - Hôpital Saint Antoine	Ollivier LEGRAND, MD-Prof			Contact (sur clinicalTrials)
CENTRE HOSPITALIER SUD FRANCILIEN	Stéphanie HAIAT, MD			Contact (sur clinicalTrials)
CH DE VERSAILLES SITE ANDRE MIGNOT	Juliette LAMBERT, MD			Contact (sur clinicalTrials)
HOPITAL NOVO	Iona VAIDA, MD			Contact (sur clinicalTrials)
INSTITUT GUSTAVE ROUSSY	Jean-Baptiste MICOL, MD			Contact (sur clinicalTrials)
Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
C H U DE LIMOGES- Hopital Dupuytren - Limoges 2998286 - France	Pascal TURLURE, MD			Contact (sur clinicalTrials)
Centre Hospitalier de St Quentin - Saint-Quentin 2977295 - France	Reda GARIDI, MD			Contact (sur clinicalTrials)
Centre Hospitalier Lyon Sud - Pierre-Bénite 2987314 - France	Maël HEIBLIG, MD			Contact (sur clinicalTrials)
CHU de la cote de Nacre - Caen 3029241 - France	Sylvain CHANTEPIE, MD			Contact (sur clinicalTrials)
CHU La Conception - Marseille 2995469 - France	Laure FARNAULT, MD			Contact (sur clinicalTrials)
CHU Nice,Hopital Archet 1 - Nice 2990440 - France	Thomas CLUZEAU, MD-Prof			Contact (sur clinicalTrials)
GHICL-Hopital St Vincent de Paul - Lille 2998324 - France	Benjamin CARPENTIER, MD			Contact (sur clinicalTrials)
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
Centre Antoine Lacassagne - Nice 2990440 - France	Luca INCHIAPPA, MD			Contact (sur clinicalTrials)
Centre Henri Becquerel - Rouen 2982652 - France	Emilie LEMASLE, MD			Contact (sur clinicalTrials)
Centre Hopsitalier de l'Est Francilien - Site de Meaux - Meaux 2994798 - France	Jamilé FRAYFER, MD			Contact (sur clinicalTrials)
Centre Hospitalier de Dunkerque - Dunkirk 3020686 - France	Adrien DANIEL, MD			Contact (sur clinicalTrials)
Centre Hospitalier de Roubaix - Roubaix 2982681 - France	Isabelle PLANTIER, MD			Contact (sur clinicalTrials)
Centre Hospitalier Dr Schaffner - Lens 3003093 - France	Claire BORIES, MD			Contact (sur clinicalTrials)
Centre Hospitalier Valenciennes - Valenciennes 2971041 - France	Sabine TRICOT, MD			Contact (sur clinicalTrials)
Centre Hospitalier Victor Dupouy - Argenteuil 3037044 - France	Ahmad AL JIJAKLI, MD			Contact (sur clinicalTrials)
CHRU de Lille- Hopital C. HURIEZ - Lille 2998324 - France	Céline BERTHON, MD			Contact (sur clinicalTrials)
Chu Amiens - Amiens 3037854 - France	Delphine LEBON, MD			Contact (sur clinicalTrials)
CHU Dijon- François Mitterrand - 21000 - Dijon 3021372 - France				Contact (sur clinicalTrials)
Hôpital Henri Mondor AP-HP - Créteil 3022530 - France	Mathieu LECLERC, MD			Contact (sur clinicalTrials)
Hôpital MILITAIRE PERCY - Clamart 3024783 - France	Jean-Valère MALFUSON, MD-Prof			Contact (sur clinicalTrials)
Hopital Pitié-Salpétrière APHP - Paris 2988507 - France	Madalina UZUNOV, MD			Contact (sur clinicalTrials)
Hôpital Saint Louis- APHP - Paris 2988507 - France	Raphaël ITZYKSON, MD-Prof			Contact (sur clinicalTrials)
Institut Curie - Hôpital René HUGUENIN - Saint-Cloud 2981041 - France	Jacques VARGAFTIG, MD			Contact (sur clinicalTrials)

Critères

Genre

Tous

Nombre d'inclusion

Critère d'inclusion

- Patient aged 18 years old or more

- Patient with newly diagnosed previously untreated de novo, secondary or
therapy-related AML

- Patients with R/R de novo, secondary or therapy-related AML

- Patient with Health insurance

Exclusion Criteria:

Critère de non inclusion

- Acute promyelocytic leukemia

- AML which is not morphologically proven (patients with granulocytic sarcoma may be
included)

- For newly diagnosed AML: previous treatment of leukemia apart from hydroxyurea.
Previous anti leukemia treatments are allowed if they were administered before the
diagnosis of AML to treat a MDS, MPN, MPN/MDS or CML

- Patient weighting less than 50 kgs

- Opposition of the patient to participate to this non-interventional study

More specific eligibility criteria might be requested to enter some study modules

NCT04777916 - A Prospective Non-interventional Study Documenting the Management and Outcomes of Adult Patients With Acute Myeloid Leukemia (AML)

Informations générales
Etablissements
Critères
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