Administration of Allogenic Red Blood Cells Loaded L-Asparaginase in Cases of Relapse of Acute Lymphoblastic Leukaemia - Full Text View

Sponsors and Collaborators:	ERYtech Pharma Centre Leon Berard
Information provided by:	ERYtech Pharma
ClinicalTrials.gov Identifier:	NCT00723346

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 I Phase II

Drug Information available for: L-Asparaginase

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Pharmacokinetics/Dynamics Study
Official Title:	Administration of Allogenic of Red Blood Cells Loaded L Asparaginase in Acute Lymphoblastic Leukemia Relapse.

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
Estimated Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Biological: GRASPA 50 UI/Kg
2: Experimental	Biological: GRASPA 100 UI/Kg
3: Experimental	Biological: GRASPA 150 UI/Kg
4: Active Comparator	Drug: native L asparaginase 10000UI/m2, 14 infusions during 4 chemotherapy cycle

Eligibility

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

Sponsors and Collaborators

ERYtech Pharma

Centre Leon Berard

Investigators

Principal Investigator:

Yves Bertrand, MD PhD

Hospices Civils de Lyon

More Information

Responsible Party:	ERYtech Pharma ( Yann Godfrin / Chief Executive Officer )
Study ID Numbers:	GRASPALL 2005-01
Study First Received:	July 24, 2008
Last Updated:	July 25, 2008
ClinicalTrials.gov Identifier:	NCT00723346
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by ERYtech Pharma:

Relapse
Lymphoma lymphoblastic

Study placed in the following topic categories:

Asparaginase
Lymphatic Diseases
Leukemia
Leukemia, Lymphoid

Immunoproliferative Disorders
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Lymphoproliferative Disorders
Lymphoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Immune System Diseases

Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009