Prospective Non-interventional Study of Adult Patients With Acute Myeloid Leukemia (AML)
ALFAPPP
A Prospective Non-interventional Study Documenting the Management and Outcomes of Adult Patients With Acute Myeloid Leukemia (AML)
1 other identifier
observational
5,000
1 country
30
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2022
Longer than P75 for all trials
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 25, 2021
CompletedFirst Posted
Study publicly available on registry
March 2, 2021
CompletedStudy Start
First participant enrolled
April 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2032
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2046
October 3, 2025
September 1, 2025
10 years
February 25, 2021
September 30, 2025
Conditions
Outcome Measures
Primary Outcomes (8)
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
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
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
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
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
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
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
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
Study Arms (5)
Standard intensive 3+7 YOUNG OR ELDERLY
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
GO, (Mylotarg®) with 3+7
Combination of sequential gemtuzumab ozogamicin (GO, Mylotarg®) with 3+7
CPX-351, (Vyxeos®)
Liposomal formulation of daunorubicin + cytarabine (CPX-351, Vyxeos®)
Less intensive chemotherapy with azacytidine combined or not with venetoclax; LDAC; ivosidenib
Less intensive chemotherapy with azacytidine either combined or not with venetoclax or low dose cytarabine (LDAC) or in AML bearing an IDH1 somatic mutation, with ivosidenib in newly diagnosed patients considered as not eligible for the more intensive options above
Refractory or relapsed AML
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.
Eligibility Criteria
Natural History and assessment of the outcomes of different standard approved treatments in recently diagnosed or relapsed/refractory AML patients
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
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, 21000, France
Centre Hospitalier de Dunkerque
Dunkirk, 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
Hopital Pitié-Salpétrière APHP
Paris, France
Hôpital Necker - 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, France
Biospecimen
Peripheral blood and bone marrow samples will be collected. Cells, and nucleic acids will be cryopreserved.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Hervé DOMBRET, PD-Prof
Acute Leukemia French Association
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 15 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2021
First Posted
March 2, 2021
Study Start
April 14, 2022
Primary Completion (Estimated)
April 1, 2032
Study Completion (Estimated)
April 1, 2046
Last Updated
October 3, 2025
Record last verified: 2025-09