Young Adult With Acute Lymphoblastic Leukemia (ALL) : a Multicentric Protocol. GRAALL 2005 : T ALL or B ALL Non Ph GRAALL 2005 R : B ALL Non Ph CD20+ GRAAPH 2005 : ALL Ph
GRAALL 2005: T ALL or B ALL non Ph
Randomization between standard versus intensified cyclophosphamide administration during a
4-drug, 4 week chemotherapy and late intensification.
GRAALL 2005 R: B ALL non Ph CD20+
Randomization between standard versus intensified cyclophosphamide administration during a
4-drug, 4 week chemotherapy and late intensification.
Randomization between Mabthera (rituximab) or no Mabthera during all induction and
consolidation courses.
Allogenic transplantation will be performed depending on unfavourable risk factors.
GRAAPH 2005: ALL Ph
Randomization between an imatinib-based induction and a chemotherapy + imatinib induction.
Allogenic transplantation will be systematically performed in the presence of related or
unrelated donors.
Autologous transplantation could be performed in the absence of a donor in case of Molecular
Residual Disease (MRD) ≤ 10-4.
Consolidation therapy will be performed in the absence of a donor in case of MRD > 10-4.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Event free survival for all patients
January 2014
No
HERVE DOMBRET, MD, PHD
Study Chair
GRAALL Group
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
GRAALL 2005
NCT00327678
May 2006
January 2014
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