Trial | NCT00723346  Report issue

Title

Administration of Allogenic Red Blood Cells Loaded L-asparaginase in Cases of Relapse of Acute Lymphoblastic Leukaemia
Administration of Allogenic of Red Blood Cells Loaded L Asparaginase in Acute Lymphoblastic Leukemia Relapse.

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    25
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 Started
Jan 31
2006
Primary Completion
Aug 31
2008
Study Completion
Mar 31
2009
Last Update
Jan 11
2012
Estimate

Biological GRASPA

50 UI/Kg

Biological GRASPA

100 UI/Kg

Biological GRASPA

150 UI/Kg

Drug native L asparaginase

10000UI/m2, 14 infusions during 4 chemotherapy cycle

1 Experimental

2 Experimental

3 Experimental

4 Active Comparator

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:
No Results Posted