Trial Information
Administration of Allogenic of Red Blood Cells Loaded L Asparaginase in Acute Lymphoblastic Leukemia Relapse.
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:
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Duration of plasmatic asparagin depletion (< 2µmol/l)
Outcome Time Frame:
PK points
Safety Issue:
No
Principal Investigator
Yves Bertrand, MD PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Hospices Civils de Lyon
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
GRASPALL 2005-01
NCT ID:
NCT00723346
Start Date:
January 2006
Completion Date:
March 2009
Related Keywords:
- Acute Lymphoblastic Leukemia
- Relapse
- Lymphoma lymphoblastic
- Leukemia
- Leukemia, Lymphoid
- Precursor Cell Lymphoblastic Leukemia-Lymphoma