Etude : ALLO-BEST /



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Acronyme / Nom
Situation thérapeutique
Traitement
Cadre réglementaire
MÀJ
Présentation de l'étude
Acronyme / Nom : ALLO-BEST

Situation thérapeutique : Greffe

Traitement :

Cadre réglementaire : RIPH1

Dernière MÀJ : 10/01/2022
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : Allogreffe de cellules souches hématopoïétiques comparée au meilleur standard de traitement disponible pour les patients âgés atteints de leucémie aigüe myéloïde : Essai randomisé de phase 3

Spécialité : Tissus lymphoïde, hématopoïétique et apparentés
Localisation : C92 - Leucémie myéloïde
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : A subject of major interest for researchers, clinicians, patients, and payers, is the role of allogeneic hematopoietic stem cell transplantation (allo-HSCT) in the treatment of these older patients with AML. With conventional induction chemotherapy or hypomethylating agents, the expected 2-year overall survival (OS) is less than 25% in patients with intermediate- or high-risk disease. The 2-year OS ranges from 50 to 56% with allo-HSCT in AML patients older than 65 years.
Performing an allo-HSCT in older patients is however still controversial because of the higher risk of non-relapse mortality (15 to 35%) and graft-versus-host disease. Depending on the center policy, patients older than 65 years will either be contraindicated for transplant or will receive allo-HSCT.
With a phase III comparative, randomized, controlled, prospective, multicenter study, the trial aim to assess prospectively the outcomes and quality of life of older patients with AML receiving allo-HSCT strategy compared to those receiving a non-transplant approach.


STUDY ARMS:
- Experimental: Allogeneic Hematopoietic Cell Transplantation
patients will undergo allo-HSCT after consolidation therapy (or completion of other appropriate non-palliative strategy) according to standard procedures of the transplant center (choice of donor, conditioning regimen, GVHD and infection prophylaxis). The use of novel therapies (such as sorafenib, midaustorine, venetoclax, etc.) will be allowed as post-transplantation maintenance strategy.

- Active Comparator: Best chemotherapy treatment
patients will be treated according to the standard procedures of the treating center for this type of population. Patients will receive the best available treatments (including additional conventional chemotherapy or other non-palliative therapies such as 5-azacytidine, decitabine, venetoclax, midaustorine, enasidenib, etc.).


CURRENT PRIMARY OUTCOME:
Overall survival [ Time Frame: 2 years after the inclusion ]

CURRENT SECONDARY OUTCOMES:
- Leukemia free survival [ Time Frame: within the 2 years after inclusion ]
- Assessment of MRD and time to relapse from inclusion up to 2 years [ Time Frame: : time between inclusion and date of relapse or at 24 months, whichever comes first] ]
- Quality of life FACT-BMT [ Time Frame: at baseline, 12 and 24 months after inclusion ]
- Quality of life EQ 5D 5L [ Time Frame: at baseline, 12 and 24 months after inclusion ]
- The Incremental cost-effectiveness ratios (ICERs) expressed in cost per quality-adjusted life-year (QALY) gained [ Time Frame: 2 years after inclusion ]
- The Incremental cost-effectiveness ratios (ICERs) expressed in cost per Life Year Gained [ Time Frame: 2 years after inclusion ]
- Non-relapse mortality [ Time Frame: within the 2 years after inclusion ]
- In allo-HSCT patients only: cumulative incidence of acute and chronic graft-versus-host disease (GVHD) [ Time Frame: within the 2 years after inclusion ]
- In allo-HSCT patients only: severity of acute and chronic graft-versus-host disease (GVHD) [ Time Frame: within the 2 years after inclusion ]

Phase : III

Stade : NA

1 (hémato)
Informations libres de droit
Critères d'inclusion
Critères de non-inclusion
Informations libres de droit
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - Men and women
- Age ≥ 65 and ≤ 75 years
- Newly diagnosed patients with de novo or secondary AML in first complete remission who are considered as potential candidates and eligible for an allo-HSCT procedure
- Presence of a donor (matched related or unrelated or haplo-mismatched) willing to donate peripheral blood stem cells
- Patient is fit for the allo-HSCT procedure
- Patient is fit for further consolidation therapy (non-transplant arm)
- Written informed consent

Critères de non-inclusion : - Acute promyelocytic leukemia (AML FAB M3)
- AML deemed not eligible for allo-HSCT
- Karnofsky score <70%
- HIV positive patient
- Life expectancy less than one month according to the attending physician
- Acute or chronic heart failure (Cardiac ejection fraction < 40%)
- Pulmonary function - diffusion capacity < 50% predicted
- Estimated glomerular filtration rate < 30 ml/min (CKD-EPI)
- Severe neurological or psychiatric disorders Recruitment procedure
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT04822766
Promoteur :
APHP
Type de sponsor : Institutionnel
75010 PARIS 10

Coordonnateur :
Dr Rémy DULERY
remy.dulery@aphp.fr
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
Centre Hospitalier Universitaire de Lille - 2 Avenue Oscar Lambret - 59000 LILLE

Investigateur :
Professeur Ibrahim YAKOUB-AGHA

TEC / ARC / IDE :
Secrétariat de recherche
fanny.miquel@
chru-lille.fr
03.20.44.57.13

Statut de l'essai : OUVERT

MAJ : 10/01/2022