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Administration of Allogenic Red Blood Cells Loaded L-asparaginase in Cases of Relapse of Acute Lymphoblastic Leukaemia (GRASPALL)

This study has been completed.
Sponsor:
Collaborator:
Centre Leon Berard
Information provided by (Responsible Party):
ERYtech Pharma
ClinicalTrials.gov Identifier:
NCT00723346
First received: July 24, 2008
Last updated: January 10, 2012
Last verified: January 2012

July 24, 2008
January 10, 2012
January 2006
August 2008   (final data collection date for primary outcome measure)
Duration of plasmatic asparagin depletion (< 2µmol/l) [ Time Frame: PK points ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00723346 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

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
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute Lymphoblastic Leukemia
  • 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
  • Experimental: 1
    Intervention: Biological: GRASPA
  • Experimental: 2
    Intervention: Biological: GRASPA
  • Experimental: 3
    Intervention: Biological: GRASPA
  • Active Comparator: 4
    Intervention: Drug: native L asparaginase
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
March 2009
August 2008   (final data collection date for primary outcome measure)

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:

Both
1 Year to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00723346
GRASPALL 2005-01
Yes
ERYtech Pharma
ERYtech Pharma
Centre Leon Berard
Principal Investigator: Yves Bertrand, MD PhD Hospices Civils de Lyon
ERYtech Pharma
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP