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

Information source: ERYtech Pharma
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Lymphoblastic Leukemia

Intervention: GRASPA (Biological); GRASPA (Biological); GRASPA (Biological); native L asparaginase (Drug)

Phase: Phase 1/Phase 2

Status: Completed

Sponsored by: ERYtech Pharma

Official(s) and/or principal investigator(s):
Yves Bertrand, MD PhD, Principal Investigator, Affiliation: Hospices Civils de Lyon

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Eligibility

Minimum age: 1 Year. Maximum age: 55 Years. Gender(s): Both.

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:

Locations and Contacts

Hopital Debrousse, Lyon 69005, France
Additional Information

Starting date: January 2006
Last updated: January 10, 2012

Page last updated: August 20, 2015

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