Status:
COMPLETED
Administration of Allogenic Red Blood Cells Loaded L-asparaginase in Cases of Relapse of Acute Lymphoblastic Leukaemia
Lead Sponsor:
ERYtech Pharma
Collaborating Sponsors:
Centre Leon Berard
Conditions:
Acute Lymphoblastic Leukemia
Eligibility:
All Genders
1-55 years
Phase:
PHASE1
PHASE2
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 * toxi...
Eligibility Criteria
Inclusion
- 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
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00723346
Start Date
January 1 2006
End Date
March 1 2009
Last Update
January 11 2012
Active Locations (1)
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1
Hopital Debrousse
Lyon, France, 69005