Expanded Access Program: Safety of Erythrocytes Encapsulating L-asparaginase (GRASPA®) in Combination With Polychemotherapy in Patients Under 55 Years Old With Acute Lymphoblastic Leukemia (ALL) at Risk to Receive Other Formulation of Asparaginase

Exclusion Criteria

• •Patient unable to receive GRASPA due to general or visceral conditions
• •* Serum creatinine ≥ 2 x ULN unless related to ALL
• •* ALT or AST ≥ 3 x ULN unless related to ALL
• •* Active clinical pancreatitis any grade or pancreatic enzyme elevation ≥ 1.5 ULN
• •* Other serious conditions according to investigator's opinion.
• •Absence of documented serological test for HIV, B and C hepatitis
• •History of grade 3 transfusional incident or any contraindication to receive blood transfusion
• •Patient under concomitant treatment likely to cause hemolysis
• •Presence of specific anti-erythrocyte antibodies preventing from getting a compatible erythrocyte concentrate for the patient.
• •Patient undergoing yellow fever vaccination.
• •Patient under phenytoin treatment.
• •Women of childbearing potential without effective contraception as well as pregnant or breast feeding women.
• •Patient already included in another clinical trial