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

• Status: No longer available
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Early Access Program to provide L-asparaginase encapsulated in Erythrocyte (GRASPA®) for patient unable to receive any other form of Asparaginase.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ERYtech Pharma
• Treatments: Asparaginase

Criteria

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