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 (EAP)

This is an expanded access trial for Acute Lymphoblastic Leukemia focused on measuring ALL L-asparaginase encapsulated erythrocytes Read More

Inclusion Criteria:

• Patients with ALL de novo or in relapse or refractory
• Eligible to a chemotherapy treatment including L-asparaginase
• Known contraindication and/or at risk of toxicity to other L-asparaginase formulation according to investigator opinion based on information available
• Patient under 55 years old
• Patient informed and consent provided (the 2 parents need to consent for children).

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