Administration of Allogenic Red Blood Cells Loaded L-asparaginase in Cases of Relapse of Acute Lymphoblastic Leukaemia

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Primary objective :

• To explore the relation between 3 doses of GRASPA and duration of asparagine depletion (< 2µmol/l)

Secondary objective :

• Pharmacokinetic / Pharmacodynamic parameters

• toxicity

• Study duration : 2 years

• Study treatment : Red blood cells loaded with L asparaginase versus native L asparaginase

• Associated treatments : COPRALL chemotherapy

• Randomization : centralised randomisation on scratching list

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ERYtech Pharma
• Collaborator: Centre Leon Berard
• Treatments: Asparaginase

Criteria

Inclusion Criteria:

• Subject between 1 and 55 year old

• Subject with acute lymphoblastic leukaemia or lymphoblastic lymphoma (excluded burkitt lymphoma) who have relapsed after first remission (medullary or SNC relapse)

• Or patient who still refractory to first line chemotherapy for an ALL

• Patient who gave written informed consent (2 parents for children)

Exclusion Criteria: