Administration of Allogenic Red Blood Cells Loaded L-asparaginase in Cases of Relapse of Acute Lymphoblastic Leukaemia
NCT ID: NCT00723346
Last Updated: 2012-01-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
25 participants
INTERVENTIONAL
2006-01-31
2009-03-31
Brief Summary
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* 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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
GRASPA
50 UI/Kg
2
GRASPA
100 UI/Kg
3
GRASPA
150 UI/Kg
4
native L asparaginase
10000UI/m2, 14 infusions during 4 chemotherapy cycle
Interventions
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GRASPA
50 UI/Kg
GRASPA
100 UI/Kg
GRASPA
150 UI/Kg
native L asparaginase
10000UI/m2, 14 infusions during 4 chemotherapy cycle
Eligibility Criteria
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Inclusion Criteria
* 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)
1 Year
55 Years
ALL
No
Sponsors
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Centre Leon Berard
OTHER
ERYtech Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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Yves Bertrand, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Hospices Civils de Lyon
Locations
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Hopital Debrousse
Lyon, , France
Countries
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Other Identifiers
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GRASPALL 2005-01
Identifier Type: -
Identifier Source: org_study_id
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