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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
History of Changes
  Purpose

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

Condition Intervention Phase
Acute Lymphoblastic Leukemia
 Biological: GRASPA
Drug: native L asparaginase
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Administration of Allogenic of Red Blood Cells Loaded L Asparaginase in Acute Lymphoblastic Leukemia Relapse.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by ERYtech Pharma:

Primary Outcome Measures:
  • Duration of plasmatic asparagin depletion (< 2µmol/l) [ Time Frame: PK points ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: January 2006
Study Completion Date: March 2009
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Biological: GRASPA
50 UI/Kg
Experimental: 2 Biological: GRASPA
100 UI/Kg
Experimental: 3 Biological: GRASPA
150 UI/Kg
Active Comparator: 4 Drug: native L asparaginase
10000UI/m2, 14 infusions during 4 chemotherapy cycle

  Eligibility

Ages Eligible for Study:   1 Year to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00723346

Locations
France
Hopital Debrousse
Lyon, France, 69005
Sponsors and Collaborators
ERYtech Pharma
Centre Leon Berard
Investigators
Principal Investigator: Yves Bertrand, MD PhD Hospices Civils de Lyon
  More Information

No publications provided

Responsible Party: ERYtech Pharma
ClinicalTrials.gov Identifier: NCT00723346     History of Changes
Other Study ID Numbers: GRASPALL 2005-01
Study First Received: July 24, 2008
Last Updated: January 10, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by ERYtech Pharma:
Relapse
Lymphoma lymphoblastic

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
 Immunoproliferative Disorders
Immune System Diseases
Asparaginase
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013