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

January 10, 2012 updated by: ERYtech Pharma

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69005
        • Hopital Debrousse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 55 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Biological: GRASPA
50 UI/Kg
Biological: GRASPA
100 UI/Kg
Biological: GRASPA
150 UI/Kg
EXPERIMENTAL: 2
Biological: GRASPA
50 UI/Kg
Biological: GRASPA
100 UI/Kg
Biological: GRASPA
150 UI/Kg
EXPERIMENTAL: 3
Biological: GRASPA
50 UI/Kg
Biological: GRASPA
100 UI/Kg
Biological: GRASPA
150 UI/Kg
ACTIVE_COMPARATOR: 4
Drug: native L asparaginase
10000UI/m2, 14 infusions during 4 chemotherapy cycle

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ERYtech Pharma

Collaborators

Centre Leon Berard

Investigators

  • Principal Investigator: Yves Bertrand, MD PhD, Hospices civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (ACTUAL)

August 1, 2008

Study Completion (ACTUAL)

March 1, 2009

Study Registration Dates

First Submitted

July 24, 2008

First Submitted That Met QC Criteria

July 25, 2008

First Posted (ESTIMATE)

July 28, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

January 11, 2012

Last Update Submitted That Met QC Criteria

January 10, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GRASPALL 2005-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Lymphoblastic Leukemia

Clinical Trials on GRASPA

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cameroon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe