Clinical trial · Expanded Access
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
NCT02197650CI-TRIAL-00035996EAPno longer availableClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Early Access Program to provide L-asparaginase encapsulated in Erythrocyte (GRASPA®) for patient unable to receive any other form of Asparaginase.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| suspension of erythrocytes encapsulating L-asparaginase | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 55 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.