Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2025-12-24 @ 4:54 PM
NCT ID:
NCT02197650
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
55 Years
Study:
NCT02197650
Study Brief:
Protocol Section:
NCT02197650