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

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

This study is ongoing, but not recruiting participants.

First Received: July 24, 2008 Last Updated: July 25, 2008 History of Changes

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

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.

Resource links provided by NLM:

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood

Drug Information available for: L-Asparaginase

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
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

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 ( 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 History of Changes
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
Acute Lymphoblastic Leukemia

Additional relevant MeSH terms:

Asparaginase
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents

Pharmacologic Actions
Leukemia
Lymphatic Diseases
Neoplasms
Therapeutic Uses
Lymphoproliferative Disorders

ClinicalTrials.gov processed this record on September 11, 2009