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

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00723346

Acronym

GRASPALL

Enrollment

Registered

2008-07-28

Start date

2006-01-31

Completion date

2009-03-31

Last updated

2012-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Lymphoblastic Leukemia

Keywords

Relapse, Lymphoma lymphoblastic

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

Interventions

BIOLOGICALGRASPA

50 UI/Kg

DRUGnative L asparaginase

10000UI/m2, 14 infusions during 4 chemotherapy cycle

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Years to 55 Years

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)

Design outcomes

Primary

Measure	Time frame
Duration of plasmatic asparagin depletion (< 2µmol/l)	PK points

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026