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

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

Detailed Description
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Some patients can not be eligible to other clinical trials / program sponsored by Erytech Pharma but could have a benefit to be treated with GRASPA. Following discussion with French regulatory authorities, it has been suggested to propose access to GRASPA to patients unable to receive any other form of L-asparaginase and not eligible to the ongoing study or other program. This exploratory study should allow it in an Expended Access Program framework.

Official Title
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Expanded Access Program for a Multicentre, Open, Non Randomized Study, Evaluating 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

Conditions
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Acute Lymphoblastic Leukemia

Intervention / Treatment
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* Drug: suspension of erythrocytes encapsulating L-asparaginase


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: suspension of erythrocytes encapsulating L-asparaginase|Erythrocytes encapsulating L-asparaginase|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ALL L-asparaginase encapsulated erythrocytes