Spots Global Cancer Trial Database for Administration of Allogenic Red Blood Cells Loaded L-asparaginase in Cases of Relapse of Acute Lymphoblastic Leukaemia
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Trial Identification
Brief Title: Administration of Allogenic Red Blood Cells Loaded L-asparaginase in Cases of Relapse of Acute Lymphoblastic Leukaemia
Official Title: Administration of Allogenic of Red Blood Cells Loaded L Asparaginase in Acute Lymphoblastic Leukemia Relapse.
Study ID: NCT00723346
Conditions
Study Description
Brief 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
Detailed Description:
Keywords
Eligibility
Minimum Age: 1 Year
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Hopital Debrousse, Lyon, , France
Contact Details
Name: Yves Bertrand, MD PhD
Affiliation: Hospices Civils de Lyon
Role: PRINCIPAL_INVESTIGATOR
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