Status:
COMPLETED
GRASPA (Erythrocytes Encapsulating L-asparaginase) in Patients With Relapse of Acute Lymphoblastic Leukemia
Lead Sponsor:
ERYtech Pharma
Conditions:
Acute Lymphoblastic Leukemia, in Relapse
Eligibility:
All Genders
1-55 years
Phase:
PHASE2
PHASE3
Brief Summary
Asparaginase is a cornerstone in the treatment of ALL, but its utility is limited by toxicities including hypersensitivity. Clinical allergy is associated with inactivation of asparaginase by antibodi...
Detailed Description
This open, randomized international Phase 2/3 study will enrol patients with relapsed ALL. The co-primary endpoints were the duration of asparagine depletion \< 2µmol/L and the incidence of asparagina...
Eligibility Criteria
Inclusion
- 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 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
- ALL t(9;22) and/or BCR-ABL positive (Philadelphia chromosome positive)
- Patient with 2nd relapse and over
- 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
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2016
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT01518517
Start Date
December 1 2009
End Date
October 1 2016
Last Update
February 2 2022
Active Locations (28)
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1
Hopital Des Enfants Reine Fabiola
Brussels, Belgium
2
Chr de La Citadelle
Liège, Belgium
3
Chu D'Angers
Angers, France
4
Hopital Saint Jacques
Besançon, France