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

ERYtech Pharma25 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acute Lymphoblastic Leukemia

Interventions

GRASPABIOLOGICAL

50 UI/Kg

GRASPABIOLOGICAL

100 UI/Kg

GRASPABIOLOGICAL

150 UI/Kg

native L asparaginase

Eligibility

Sex: ALLMin age: 1 YearMax age: 55 Years

Medical Language ↔ Plain English

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:

Locations (1)

Hopital Debrousse

Lyon, France

Outcomes

Primary Outcomes

Duration of plasmatic asparagin depletion (< 2µmol/l)

Time frame: PK points

Data from ClinicalTrials.gov

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