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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04777916
Other study ID # ALFA PPP Study
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 14, 2022
Est. completion date April 1, 2046

Study information

Verified date February 2023
Source Acute Leukemia French Association
Contact Karine CELLI LEBRAS, Mrs
Phone 33 1 57 27 67 17
Email karine.celli-lebras@aphp.fr
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 2500
Est. completion date April 1, 2046
Est. primary completion date April 1, 2032
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Exclusion Criteria: - 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

Study Design


Locations

Country Name City State
France Chu Amiens Amiens
France Centre Hospitalier Victor Dupouy Argenteuil
France AP-HP-GHU - Hôpital AVICENNE Bobigny
France CHU de la cote de Nacre Caen
France Hôpital MILITAIRE PERCY Clamart
France Centre hospitalier Sud Francilien Corbeil-Essonnes
France Hôpital Henri Mondor AP-HP Créteil
France CHU Dijon- François Mitterrand Dijon
France Centre Hospitalier de Dunkerque Dunkerque
France Centre Hospitalier de Versailles André Mignot Le Chesnay
France Centre Hospitalier Dr Schaffner Lens
France CHRU de Lille- Hopital C. HURIEZ Lille
France GHICL-Hopital St Vincent de Paul Lille
France C H U DE LIMOGES- Hopital Dupuytren Limoges
France CHU La Conception Marseille
France Centre Hopsitalier de l'Est Francilien - Site de Meaux Meaux
France Centre Antoine Lacassagne Nice
France CHU Nice,Hopital Archet 1 Nice
France Hôpital Necker - APHP Paris
France Hopital Pitié-Salpétrière APHP Paris
France Hôpital SAINT ANTOINE-APHP Paris
France Hôpital Saint Louis- APHP Paris
France Centre Hospitalier Lyon Sud Pierre-Bénite
France Centre Hospitalier René Dubos Pontoise
France Centre Hospitalier de Roubaix Roubaix
France Centre Henri Becquerel Rouen
France Institut Curie - Hôpital René HUGUENIN Saint-Cloud
France Centre Hospitalier de St Quentin Saint-Quentin
France Centre Hospitalier Valenciennes Valenciennes
France Institut Gustave Roussy Villejuif

Sponsors (1)

Lead Sponsor Collaborator
Acute Leukemia French Association

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary OS The primary objective of this multicenter non-interventional study is to record and prospectively evaluate the real-life characteristics, treatments and outcomes of adult patients with newly diagnosed or R/R AML, when managed and treated in the French ALFA centers according to standard practices outside of a clinical trial.
The two co-primary endpoints are event-free (EFS) and overall survival (OS) estimations at 1, 3, 5 and 10 years:
From first treatment initiation in patients with newly diagnosed AML
From the date of relapse/refractoriness (R/R) in patients, with R/R AML
1 year
Primary OS The primary objective of this multicenter non-interventional study is to record and prospectively evaluate the real-life characteristics, treatments and outcomes of adult patients with newly diagnosed or R/R AML, when managed and treated in the French ALFA centers according to standard practices outside of a clinical trial.
The two co-primary endpoints are event-free (EFS) and overall survival (OS) estimations at 1, 3, 5 and 10 years:
From first treatment initiation in patients with newly diagnosed AML
From the date of relapse/refractoriness (R/R) in patients, with R/R AML
3 years
Primary OS The primary objective of this multicenter non-interventional study is to record and prospectively evaluate the real-life characteristics, treatments and outcomes of adult patients with newly diagnosed or R/R AML, when managed and treated in the French ALFA centers according to standard practices outside of a clinical trial.
The two co-primary endpoints are event-free (EFS) and overall survival (OS) estimations at 1, 3, 5 and 10 years:
From first treatment initiation in patients with newly diagnosed AML
From the date of relapse/refractoriness (R/R) in patients, with R/R AML
5 years
Primary OS The primary objective of this multicenter non-interventional study is to record and prospectively evaluate the real-life characteristics, treatments and outcomes of adult patients with newly diagnosed or R/R AML, when managed and treated in the French ALFA centers according to standard practices outside of a clinical trial.
The two co-primary endpoints are event-free (EFS) and overall survival (OS) estimations at 1, 3, 5 and 10 years:
From first treatment initiation in patients with newly diagnosed AML
From the date of relapse/refractoriness (R/R) in patients, with R/R AML
10 years
Primary EFS The primary objective of this multicenter non-interventional study is to record and prospectively evaluate the real-life characteristics, treatments and outcomes of adult patients with newly diagnosed or R/R AML, when managed and treated in the French ALFA centers according to standard practices outside of a clinical trial.
The two co-primary endpoints are event-free (EFS) and overall survival (OS) estimations at 1, 3, 5 and 10 years:
From first treatment initiation in patients with newly diagnosed AML
From the date of relapse/refractoriness (R/R) in patients, with R/R AML
1 year
Primary EFS The primary objective of this multicenter non-interventional study is to record and prospectively evaluate the real-life characteristics, treatments and outcomes of adult patients with newly diagnosed or R/R AML, when managed and treated in the French ALFA centers according to standard practices outside of a clinical trial.
The two co-primary endpoints are event-free (EFS) and overall survival (OS) estimations at 1, 3, 5 and 10 years:
From first treatment initiation in patients with newly diagnosed AML
From the date of relapse/refractoriness (R/R) in patients, with R/R AML
3 years
Primary EFS The primary objective of this multicenter non-interventional study is to record and prospectively evaluate the real-life characteristics, treatments and outcomes of adult patients with newly diagnosed or R/R AML, when managed and treated in the French ALFA centers according to standard practices outside of a clinical trial.
The two co-primary endpoints are event-free (EFS) and overall survival (OS) estimations at 1, 3, 5 and 10 years:
From first treatment initiation in patients with newly diagnosed AML
From the date of relapse/refractoriness (R/R) in patients, with R/R AML
5 years
Primary EFS The primary objective of this multicenter non-interventional study is to record and prospectively evaluate the real-life characteristics, treatments and outcomes of adult patients with newly diagnosed or R/R AML, when managed and treated in the French ALFA centers according to standard practices outside of a clinical trial.
The two co-primary endpoints are event-free (EFS) and overall survival (OS) estimations at 1, 3, 5 and 10 years:
From first treatment initiation in patients with newly diagnosed AML
From the date of relapse/refractoriness (R/R) in patients, with R/R AML
10 years
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