Titre A Phase 2 Study of the JAK1/JAK2 Inhibitor Ruxolitinib With Chemotherapy in Children With De Novo High-Risk CRLF2-Rearranged and/or JAK Pathway-Mutant Acute Lymphoblastic Leukemia
Protocole ID COG-AALL1521
ClinicalTrials.gov ID NCT02723994
Type(s) de cancer Pédiatrique divers
Phase Phase II
Institution CENTRE UNIVERSITAIRE DE SANTE MCGILL
   HOPITAL DE MONTREAL POUR ENFANTS
      1001 boul. Décarie , Montréal, QC, H4A 3J1
Ville Montréal
Investigateur(trice) principal(e) Dre Sharon Abish
Coordonnateur(trice) Stephanie Badour
 514-412-4400 poste 23807
Statut Actif en recrutement
Critètes d'éligibilité
  • 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
Critètes d'exclusion
  • 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