An Escalating Dose Phase IIa Study of L-Asparaginase Encapsulated in Erythrocytes (GRASPA®) in Association With Polychemotherapy During Induction Phase for Treatment of Elderly Patients With Acute Lymphoblastic Leukaemia (ALL), Aged 55 Years and Over, With Philadelphia Chromosome-negative (ALL Ph-)
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
efficacy and toxicity combined
The main evaluation criterion is a composite efficacy/toxicity criterion Efficacy:Percentage of patients responding to treatment i.e. patients with blood levels of plasma asparagine ≤ 2µM over a period of at least 7 days after the administration of GRASPA®. Toxicity:Grade 2,3 or 4 pancreatic toxicity, hepatic toxicity, allergy / Grade 3 or 4 deep cerebral thrombosis / Haematological toxicity /Any other grade 4 toxicity
End of induction (2 months)
Yes
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
GRASPALL/GRAALLSA2-2008
NCT01523782
April 2009
October 2012
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