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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NO_LONGER_AVAILABLE

Study Classification

EXPANDED_ACCESS

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.

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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.

Conditions

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Acute Lymphoblastic Leukemia

Interventions

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suspension of erythrocytes encapsulating L-asparaginase

Erythrocytes encapsulating L-asparaginase

Intervention Type DRUG

Other Intervention Names

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GRASPA® eryaspase

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

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No