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

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ClinicalTrials.gov Identifier: NCT00723346
Recruitment Status : Completed
First Posted : July 28, 2008
Last Update Posted : January 11, 2012
Sponsor:
Collaborator:
Centre Leon Berard
Information provided by (Responsible Party):
ERYtech Pharma

Brief 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

Condition or disease Intervention/treatment Phase
Acute Lymphoblastic Leukemia Biological: GRASPA Drug: native L asparaginase Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Administration of Allogenic of Red Blood Cells Loaded L Asparaginase in Acute Lymphoblastic Leukemia Relapse.
Study Start Date : January 2006
Actual Primary Completion Date : August 2008
Actual Study Completion Date : March 2009


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Duration of plasmatic asparagin depletion (< 2µmol/l) [ Time Frame: PK points ]


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Ages Eligible for Study:   1 Year to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: ERYtech Pharma
ClinicalTrials.gov Identifier: NCT00723346     History of Changes
Other Study ID Numbers: GRASPALL 2005-01
First Posted: July 28, 2008    Key Record Dates
Last Update Posted: January 11, 2012
Last Verified: January 2012

Keywords provided by ERYtech Pharma:
Relapse
Lymphoma lymphoblastic

Additional relevant MeSH terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Recurrence
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Disease Attributes
Pathologic Processes
Asparaginase
Antineoplastic Agents