Phase 2/3 Study Evaluating Efficacy and Safety of Erythrocytes Encapsulating L-asparaginase (GRASPA)Versus Reference L-asparaginase Treatment in Combination With Standard Polychemotherapy in Patient With First Recurrence of Philadelphia Negative Acute Lymphoblastic Leukemia
Inclusion Criteria:
- Patient from 1 to 55 years old (Children and adolescents from 1 to 17 years/ Adults
from 18 to 55 years)
- Patients with 1st ALL relapse, which could be either isolated bone marrow relapse, or
combined (medullary and extra-medullary) relapse, or extra-medullary isolated CNS
relapse; or lymphoblastic lymphoma (excepted Burkitt lymphoma) OR Failure to ALL
first line treatment (no complete remission obtained)
- Patient previously treated with free E.Coli L-asparaginase form or pegylated one
- Performance Status ≤ 2 (WHO score)
- Patient informed and consent provided (the 2 parents need to consent when children
are below 18)
Exclusion Criteria:
- ALL t(9;22) and/or BCR-ABL positive (Philadelphia chromosome positive)
- Patient with 2nd relapse and over
- Isolated extra-medullary relapse, excluding isolated CNS relapse
- Women of childbearing potential without effective contraception as well as pregnant
or breast feeding women
- Patient unable to receive treatments used in global chemotherapy protocols, due to
general or visceral conditions such as:Severe cardiac impairment (NYHA grade 3 or 4
cardiomyopathy)/Serum creatinine 2 x ULN unless related to ALL /ALT or AST 5 x ULN
unless related to ALL /Pancreatitis history /Other malignancy that ALL / Severe
Infection, HIV positive, active hepatitis related to B or C virus infection / Trisomy
21 / Other serious conditions according to investigator's opinion
- Known grade 4 allergic reaction to E.Coli L-asparaginase (according NCI-CTCAE,
Version 3.0)
- History of grade 3 transfusional incident
- Presence of specific anti-erythrocyte antibodies preventing from getting a compatible
erythrocyte concentrate for the patient
- Patient under concomitant treatment likely to cause hemolysis
- Patient undergoing yellow fever vaccination
- Patient under phenytoin treatment
- Patient included in previous clinical study less than 6 weeks ago