Title Allogeneic Stem Cell Transplant for Children and Adolescents With Acute Lymoblastic Leukemia FORUM - Pharmacogenomic Study
Protocole ID FORUM
ClinicalTrials.gov ID NCT02670564
Cancer Type(s) Pediatric
Phase Phase IV
Stage
Study Type Genetic
Drug
Institution CENTRE UNIVERSITAIRE DE SANTE MCGILL
   HOPITAL DE MONTREAL POUR ENFANTS
      1001 boul. Décarie , Montréal, QC, H4A 3J1
City Montréal
Principal Investigator Dr. David Mitchell
Coordinator Samira Mezziani
514-412-4400 poste 22930
Status Recruiting
Activation Date
Eligibility Criteria
  • age at time of screening less than 18 years old
  • Patients with ALL (except for patients with B-ALL)
  • indication for allogeneic HSCT
  • complete remission (CR) before HSCT
  • written consent of the parents (legal guardian) and, if necessary, the minor patient via "Informed Consent Form"
  • no pregnancy
  • no secondary malignancy
  • no previous HSCT
  • HSCT is performed in a study participating centre
Exclusion Criteria
  • Non Hodgkin-Lymphoma
  • ALL with extramedullary involvement with indication for TBI
  • CNS involvement at the timepoint of screening
  • Trisomy 21
  • The whole protocol or essential parts are declined either by patient himself/herself or the respective legal guardian
  • No consent is given for saving and propagation of anonymous medical data for study reasons
  • Severe concomitant disease that does not allow treatment according to the protocol at the investigator's discretion (e.g. malformation syndromes, cardiac malformations, metabolic disorders)
  • Karnofsky / Lansky score < 50%
  • Subjects unwilling or unable to comply with the study procedures