TITRE Étude de phase II visant à évaluer le ruxolitinib, un inhibiteur de JAK1/JAK2, en association avec la chimiothérapie chez des enfants atteints de leucémie aiguë lymphoblastique de novo à risque élevé présentant un réarrangement de CRLF2 et/ou une mutation dans la voie JAK
PROTOCOLE ID COG-AALL1521
CLINICAL TRIAL.gov ID NCT02723994
TYPE(S) DE CANCER Pédiatrique divers
PHASE Phase II
TYPE D'ÉTUDE
INSTITUTION CENTRE HOSPITALIER UNIVERSITAIRE SAINTE-JUSTINE
3175 Chemin de la Côte Sainte-Catherine
(514) 345-4931
VILLE Montréal
INVESTIGATEUR(RICE) PRINCIPAL(E) Yvan Samson
COORDONATEUR(RICE) Clemence Noury
clemence.noury@recherche-ste-justine.qc.ca
514-345-4931 poste 6848
STATUT  Actif en recrutement
CRITÈRES D'ÉLIGIBILITÉ (EN)
  • De novo high-risk (HR) Ph-like B-ALL for which any of following criteria are present at diagnosis:

    • Age ≥ 10 years
    • White blood cell (WBC) ≥ 50 × 10^3/μL
    • CNS3 leukemia
  • One of the following Ph-like ALL genetic lesions must be present in the diagnostic bone marrow or peripheral blood sample:

    • CRLF2 rearrangement with JAK1 or JAK2 mutation (JAK+)
    • CRLF2 rearrangement without JAK mutation
    • Other JAK pathway alterations (eg, JAK2 fusions, erythropoietin receptor (EPO-R) fusions, SH2B3 deletions, interleukin-7 receptor-alpha (IL7RA) mutations) with or without CRLF2 rearrangement
  • Completed a 4-drug Induction therapy regimen (modified aBFM regimen or equivalent) in Study AALL1131 or as the institutional standard of care for HR B-ALL and have had end-Induction minimal residual disease (MRD) assessed
  • Male and female subjects of reproductive non childbearing potential or willing to take appropriate precautions to avoid pregnancy or fathering a child for the duration of study participation
CRITÈRES D'EXCLUSION (EN)
  • Receipt of any other cytotoxic chemotherapy before Induction therapy, with exception of hydroxyurea or steroid pretreatment
  • Trisomy 21 (Down syndrome)
  • BCR-ABL1-rearranged (Ph+) ALL
  • Calculated creatinine clearance or radioisotope glomerular filtration rate < 70 mL/min/1.73 m^2
  • Alanine aminotransferase ≥ 3 × upper limit of normal (ULN) for age
  • Direct bilirubin ≥ 1.5 × ULN (may be assumed if total bilirubin is below ULN)
  • History or evidence of cirrhosis
  • Platelet count < 75 × 10^3/μL
  • Absolute neutrophil count (ANC) < 750/μL
  • Positive screen for hepatitis B or C
  • Known human immunodeficiency virus infection