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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

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

Status
NO_LONGER_AVAILABLE
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT02197650
Acronym
EAP
Enrollment
Unknown
Registered
2014-07-23
Start date
Unknown
Completion date
Unknown
Last updated
2018-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Lymphoblastic Leukemia

Keywords

ALL L-asparaginase encapsulated erythrocytes

Brief summary

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

Detailed description

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.

Interventions

DRUGsuspension of erythrocytes encapsulating L-asparaginase

Erythrocytes encapsulating L-asparaginase

Sponsors

ERYtech Pharma
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
ALL
Age
No minimum to 55 Years
Healthy volunteers
No

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026