Administration of Allogenic Red Blood Cells Loaded L-asparaginase in Cases of Relapse of Acute Lymphoblastic Leukaemia
Information source: ERYtech Pharma
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Lymphoblastic Leukemia
Intervention: GRASPA (Biological); GRASPA (Biological); GRASPA (Biological); native L asparaginase (Drug)
Phase: Phase 1/Phase 2
Status: Completed
Sponsored by: ERYtech Pharma Official(s) and/or principal investigator(s): Yves Bertrand, MD PhD, Principal Investigator, Affiliation: Hospices Civils de Lyon
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
Clinical Details
Official title: Administration of Allogenic of Red Blood Cells Loaded L Asparaginase in Acute Lymphoblastic Leukemia Relapse.
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Duration of plasmatic asparagin depletion (< 2µmol/l)
Eligibility
Minimum age: 1 Year.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
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:
Locations and Contacts
Hopital Debrousse, Lyon 69005, France
Additional Information
Starting date: January 2006
Last updated: January 10, 2012
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