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) (ALFAPPP)

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

29 juin 2024

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®), 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	04/07/2024 11:04:55	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	En recrutement IDF		Contact (sur clinicalTrials)
AP-HP - Hôpital Necker-Enfants Malades	Ambroise MARCAIS, MD	En recrutement IDF		Contact (sur clinicalTrials)
AP-HP - Hôpital Saint Antoine	Ollivier LEGRAND, MD-Prof	En recrutement IDF		Contact (sur clinicalTrials)
CENTRE HOSPITALIER SUD FRANCILIEN	Stéphanie HAIAT, MD	En recrutement IDF		Contact (sur clinicalTrials)
CH DE VERSAILLES SITE ANDRE MIGNOT	Juliette LAMBERT, MD	En recrutement IDF		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
C H U DE LIMOGES- Hopital Dupuytren - Limoges - France	Pascal TURLURE, MD	En recrutement		Contact (sur clinicalTrials)
Centre Antoine Lacassagne - Nice - France	Anna BORRA, MD	En recrutement		Contact (sur clinicalTrials)
Centre Henri Becquerel - Rouen - France	Emilie LEMASLE, MD	En recrutement		Contact (sur clinicalTrials)
Centre Hopsitalier de l'Est Francilien - Site de Meaux - Meaux - France	Jamilé FRAYFER, MD	En recrutement		Contact (sur clinicalTrials)
Centre Hospitalier de Dunkerque - Dunkerque - France	Kevin James WATTEBLED, MD	En recrutement		Contact (sur clinicalTrials)
Centre Hospitalier de Roubaix - Roubaix - France	Isabelle PLANTIER, MD	En recrutement		Contact (sur clinicalTrials)
Centre Hospitalier de St Quentin - Saint-Quentin - France	Reda GARIDI, MD	En recrutement		Contact (sur clinicalTrials)
Centre Hospitalier Dr Schaffner - Lens - France	Claire BORIES, MD	En recrutement		Contact (sur clinicalTrials)
Centre Hospitalier Lyon Sud - Pierre-Bénite - France	Maël HEIBLIG, MD	En recrutement		Contact (sur clinicalTrials)
Centre Hospitalier Valenciennes - Valenciennes - France	Sabine TRICOT, MD	Recrutement non commencé		Contact (sur clinicalTrials)
Centre Hospitalier Victor Dupouy - Argenteuil - France	Ahmad AL JIJAKLI, MD	En recrutement		Contact (sur clinicalTrials)
CHRU de Lille- Hopital C. HURIEZ - Lille - France	Céline BERTHON, MD	En recrutement		Contact (sur clinicalTrials)
Chu Amiens - Amiens - France	Delphine LEBON, MD	En recrutement		Contact (sur clinicalTrials)
CHU de la cote de Nacre - Caen - France	Sylvain CHANTEPIE, MD	En recrutement		Contact (sur clinicalTrials)
CHU Dijon- François Mitterrand - 21000 - Dijon - France		Active, sans recrutement		Contact (sur clinicalTrials)
CHU La Conception - Marseille - France	Laure FARNAULT, MD	En recrutement		Contact (sur clinicalTrials)
CHU Nice,Hopital Archet 1 - Nice - France	Thomas CLUZEAU, MD-Prof	En recrutement		Contact (sur clinicalTrials)
GHICL-Hopital St Vincent de Paul - Lille - France	Benjamin CARPENTIER, MD	En recrutement		Contact (sur clinicalTrials)
Hôpital Henri Mondor AP-HP - Créteil - France	Cécile PAUTAS, MD	En recrutement		Contact (sur clinicalTrials)
Hôpital MILITAIRE PERCY - Clamart - France	Jean-Valère MALFUSON, MD-Prof	En recrutement		Contact (sur clinicalTrials)
Hopital Pitié-Salpétrière APHP - Paris - France	Madalina UZUNOV, MD	En recrutement		Contact (sur clinicalTrials)
Hôpital Saint Louis- APHP - Paris - France	Raphaël ITZYKSON, MD-Prof	En recrutement		Contact (sur clinicalTrials)
Institut Curie - Hôpital René HUGUENIN - Saint-Cloud - France	Jacques VARGAFTIG, MD	Recrutement non commencé		Contact (sur clinicalTrials)
Institut Gustave Roussy - Villejuif - France	Jean-Baptiste MICOL, MD	En recrutement		Contact (sur clinicalTrials)

Critères

Genre

Tous

Nombre d'inclusion

Critère d'inclusion

Inclusion Criteria:

- 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

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

- 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) (ALFAPPP)

Informations générales
Etablissements
Critères
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