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Clinical trial

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

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Last updated:1st Jan 2006

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


Study Type: Interventional
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Administration of Allogenic of Red Blood Cells Loaded L Asparaginase in Acute Lymphoblastic Leukemia Relapse.
Enrollment: 25
Study Start Date: January 2006
Study Completion Date: March 2009
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)

Arms:
- Experimental:
1
- Experimental: 2
- Experimental: 3
- Active Comparator: 4

Category Value
Study start date 2006-01-01

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