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

ERYtech Pharma

Status and phase: Completed; Phase 2; Phase 1

Conditions: Acute Lymphoblastic Leukemia

Treatments: Biological: GRASPA; Drug: native L asparaginase

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00723346

GRASPALL 2005-01

Details and patient eligibility

About

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

Enrollment: 25 patients

Sex: All

Ages: 1 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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:

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 4 patient groups

1

Experimental group

Treatment:

Biological: GRASPA

Biological: GRASPA

Biological: GRASPA

2

Experimental group

Treatment:

Biological: GRASPA

Biological: GRASPA

Biological: GRASPA

3

Experimental group

Treatment:

Biological: GRASPA

Biological: GRASPA

Biological: GRASPA

4

Active Comparator group

Treatment:

Drug: native L asparaginase