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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014