Etude : AG 120-C-009 / AGILE

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Acronyme / Nom
Situation thérapeutique
Cadre réglementaire
Présentation de l'étude
Acronyme / Nom : AG 120-C-009 / AGILE

Situation thérapeutique :

Traitement :

Cadre réglementaire : RIPH2

Dernière MÀJ : 30/04/2021
CIM10 - Localisation(s)
Informations principales
Titre : Étude de phase 3, multicentrique, en double aveugle, randomisée, contrôlée contre placebo, de l’AG-120 en association avec l’azacitidine chez des sujets âgés de plus de 18 ans présentant une leucémie myéloïde aiguë non traitée auparavant et porteurs d’une mutation IDH1

Spécialité : Tissus lymphoïde, hématopoïétique et apparentés
Localisation : C92 - Leucémie myéloïde
Informations complémentaires
Schéma : Study AG120-C-009 is a global, Phase 3, multicenter, double-blind, randomized, placebo-controlled clinical trial to evaluate the efficacy and safety of AG-120 (ivosidenib) + azacitidine vs placebo + azacitidine in adult subjects with previously untreated IDH1m AML who are considered appropriate candidates for non-intensive therapy. The primary endpoint is Overall Survival (OS). The key secondary efficacy endpoints are Event free Survival (EFS), rate of complete remission (CR), Rate of CR and complete remission with partial hematologic recovery (CRh), and overall response rate (ORR). Subjects eligible for study treatment based on Screening assessments will be randomized 1:1 to receive oral AG-120 or matched placebo, both administered in combination with subcutaneous (SC) or intravenous (IV) azacitidine. An estimated 392 subjects will participate in the study.

2 treatment arms:
- Experimental: AG-120 (ivosidenib) with Azacitidine : Continuous 28-day cycles of AG-120 (ivosidenib) 500 mg orally (PO) once daily (QD) in combination with azacitidine 75 mg/m2/day SC or IV for the first week of each cycle
- Placebo Comparator: Placebo with Azacitidine : Continuous 28-day cycles of Placebo orally (PO) once daily (QD) in combination with azacitidine 75 mg/m2/day SC or IV for the first week of each cycle

Phase : III

Stade : NA

Critères d'inclusion
Critères de non-inclusion
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - Be ≥ 18 years of age.
- Have previously untreated AML, defined according to WHO criteria, with ≥ 20% leukemic blasts in the bone marrow. Subjects with extramedullary disease alone (ie, no detectable bone marrow and no detectable peripheral blood AML) are not eligible for the study.
- Have an isocitrate dehydrogenase 1 (IDH1) mutation
- Have an ECOG Performance Status score of 0 to 2.
- Have adequate hepatic function
- Have adequate renal function
- Have agreed to undergo serial blood and bone marrow sampling.
- Be able to understand and willing to sign an informed consent form (ICF).
- Be willing to complete Quality of Life assessments during the study
- If female with reproductive potential, must have a negative serum pregnancy test prior to the start of study therapy. Females of reproductive potential, as well as fertile men and their female partners of reproductive potential, must agree to use 2 effective forms of contraception.

Critères de non-inclusion : - Are candidates for and willing to receive intensive IC for their AML.
- Have received any prior treatment for AML with the exception of hydroxyurea.
- Have received a hypomethylating agent for myelodysplastic syndrome (MDS).
- Subjects who had previously received an experimental agent for MDS may not be randomized until a washout period has elapsed since the last dose of that agent.
- Have received prior treatment with an IDH1 inhibitor.
- Have a known hypersensitivity to any of the components of AG-120, matched placebo, or azacitidine.
- Are female and pregnant or breastfeeding.
- Have an active, uncontrolled, systemic fungal, bacterial, or viral infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment.
- Have a prior history of cancer other than MDS or myeloproliferative disorder, unless the subject has been free of the disease for ≥ 1 year prior to the start of study treatment.
- Have had significant active cardiac disease within 6 months prior to the start of study treatment
- Have any condition that increases the risk of abnormal ECG or cardiac arrhythmia
- Have a condition that limits the ingestion or absorption of drugs administered by mouth
- Have uncontrolled hypertension (systolic blood pressure [BP] > 180 mmHg or diastolic BP > 100 mmHg).
- Have clinical symptoms suggestive of active central nervous system (CNS) leukemia or known CNS leukemia.
- Have immediate, life-threatening, severe complications of leukemia, such as uncontrolled bleeding, pneumonia with hypoxia or sepsis, and/or disseminated intravascular coagulation.
- Have any other medical or psychological condition deemed by the Investigator to be likely to interfere with the subject's ability to give informed consent or participate in the study.
Informations relatives au promoteur
Promoteur :
Type de sponsor : Industriel

Coordonnateur :
Centre investigateur
Informations relatives aux investigateurs
Centre investigateur :
Institut d'Hématologie Bas-Normand (IHBN) - Avenue de la Cote de Nacre - 14000 CAEN

Investigateur :


Statut de l'essai : CLOS

MAJ : 13/01/2021