Pédiatrique divers

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TITRE (EN) Allogeneic Stem Cell Transplantation for Children and Adolescents With Acute Lymphoblastic Leukaemia
PROTOCOLE ID FORUM
CLINICAL TRIAL.gov ID NCT01949129
TYPE(S) DE CANCER Pédiatrique divers
PHASE
TYPE D'ÉTUDE
INSTITUTION CENTRE UNIVERSITAIRE DE SANTE MCGILL
1001 boul. Décarie
VILLE Montréal
INVESTIGATEUR(RICE) PRINCIPAL(E) David Mitchell
COORDONATEUR(RICE) Samira Mezziani
mch.rho@muhc.mcgill.ca
514-412-4400 poste 22930
STATUT  Actif en recrutement
CRITÈRES D'ÉLIGIBILITÉ (EN)

Patients with ALL (except for patients with B-ALL) who fulfil the following criteria:

  • age at time of screening less than 18 years
  • 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
CRITÈRES D'EXCLUSION (EN)
  • Patients who do not fulfil the inclusion 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