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

Acute Lymphoblastic Leukemia Clinical Trial

— GRASPALL  

Official title:

Administration of Allogenic of Red Blood Cells Loaded L Asparaginase in Acute Lymphoblastic Leukemia Relapse.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00723346
• Other study ID #: GRASPALL 2005-01
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: July 24, 2008
• Last updated: January 10, 2012
• Start date: January 2006
• Est. completion date: March 2009

Study information

• Verified date: January 2012
• Source: ERYtech Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: March 2009
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 55 Years

Eligibility

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:

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Biological:
• GRASPA
50 UI/Kg
• GRASPA
100 UI/Kg
• GRASPA
150 UI/Kg

Drug:
• native L asparaginase
10000UI/m2, 14 infusions during 4 chemotherapy cycle

Locations

Country	Name	City	State
France	Hopital Debrousse	Lyon

Sponsors (2)

Lead Sponsor	Collaborator
ERYtech Pharma	Centre Leon Berard

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of plasmatic asparagin depletion (< 2µmol/l)		PK points	No