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

Sponsor

ERYtech Pharma (Industry)

Overall Status

Completed

CT.gov ID

NCT00723346

Collaborator

Centre Leon Berard (Other)

Enrollment

Location

Arms

37.9

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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 Biological: GRASPA Biological: GRASPA Drug: native L asparaginase	Phase 1/Phase 2

Study Design

Study Type:

Interventional

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 :

Jan 1, 2006

Actual Primary Completion Date :

Aug 1, 2008

Actual Study Completion Date :

Mar 1, 2009

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Duration of plasmatic asparagin depletion (< 2µmol/l) [PK points]

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)