GRAALL 2003 Trial (ALL 15-59 Years). Feasibility of Risk-Adapted Therapy in Young Adult Acute Lymphoblastic Leukemia: a Multicenter Trial
1) baseline (BL) : WBC30G/L in B-lineage, CNS involvement, MLL-AF4 and E2A-PBX fusions,
haploidy/near-triploidy; 2) early response (ER) : corticoresistance after prophase (CsR),
chemoresistance at Day 8 (ChR); all CsR and/or ChR patients are planned to receive higher
doses of cyclophosphamide (HyperC) at Day 15 of induction; 3) induction response (IR) : no
CR or Ig-TCR minimal residual disease (MRD) 10-2 after standard or HyperC induction.
Allogeneic stem cell transplantation is proposed to patients with a donor and at least one
BL, ER, or IR factor.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Hierarchical evaluation of baseline poor-prognosis factors and response to initial therapy in younger adults with ALL
Françoise HUGUET-RIGAL, MD
Principal Investigator
University Hospital, Toulouse
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
0200701
NCT00222027
November 2003
December 2008
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