MedTrace Logo

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

NCT00723346 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2012-01-11

No results posted yet for this study

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

Conditions

Interventions

BIOLOGICAL

GRASPA

50 UI/Kg

BIOLOGICAL

GRASPA

100 UI/Kg

BIOLOGICAL

GRASPA

150 UI/Kg

DRUG

native L asparaginase

10000UI/m2, 14 infusions during 4 chemotherapy cycle

Sponsors & Collaborators

  • Centre Leon Berard

    collaborator OTHER

  • ERYtech Pharma

    lead INDUSTRY

Principal Investigators

  • Yves Bertrand, MD PhD · Hospices Civils de Lyon

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2008-08-31
Completion
2009-03-31

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00723346 on ClinicalTrials.gov