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

Phase 1

Completed

• Conditions: Acute Lymphoblastic Leukemia
• Interventions: Biological: GRASPA; Drug: native L asparaginase

• Registration Number: NCT00723346
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2008-07-24
• Study First Submitted QC: 2008-07-25
• Study First Posted: 2008-07-28
• Primary Completion: 2008-08
• Study Completion: 2009-03
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-10
• Last Update Posted: 2012-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	GRASPA	-
2	GRASPA	-
3	GRASPA	-
4	native L asparaginase	-

Primary Outcome Measures

Name	Time	Method
Duration of plasmatic asparagin depletion (< 2µmol/l)	PK points

Trial Locations

Locations (1)

Hopital Debrousse; 🇫🇷 Lyon, France