Administration of Allogenic Red Blood Cells Loaded L-asparaginase in Cases of Relapse of Acute Lymphoblastic Leukaemia (GRASPALL)
Primary Purpose
Acute Lymphoblastic Leukemia
Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
GRASPA
GRASPA
GRASPA
native L asparaginase
Sponsored by
About this trial
This is an interventional treatment trial for Acute Lymphoblastic Leukemia focused on measuring Relapse, Lymphoma lymphoblastic
Eligibility 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:
Sites / Locations
- Hopital Debrousse
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Arm Label
1
2
3
4
Arm Description
Outcomes
Primary Outcome Measures
Duration of plasmatic asparagin depletion (< 2µmol/l)
Secondary Outcome Measures
Full Information
NCT ID
NCT00723346
First Posted
July 24, 2008
Last Updated
January 10, 2012
Sponsor
ERYtech Pharma
Collaborators
Centre Leon Berard
1. Study Identification
Unique Protocol Identification Number
NCT00723346
Brief Title
Administration of Allogenic Red Blood Cells Loaded L-asparaginase in Cases of Relapse of Acute Lymphoblastic Leukaemia
Acronym
GRASPALL
Official Title
Administration of Allogenic of Red Blood Cells Loaded L Asparaginase in Acute Lymphoblastic Leukemia Relapse.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ERYtech Pharma
Collaborators
Centre Leon Berard
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lymphoblastic Leukemia
Keywords
Relapse, Lymphoma lymphoblastic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Experimental
Arm Title
4
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
GRASPA
Intervention Description
50 UI/Kg
Intervention Type
Biological
Intervention Name(s)
GRASPA
Intervention Description
100 UI/Kg
Intervention Type
Biological
Intervention Name(s)
GRASPA
Intervention Description
150 UI/Kg
Intervention Type
Drug
Intervention Name(s)
native L asparaginase
Intervention Description
10000UI/m2, 14 infusions during 4 chemotherapy cycle
Primary Outcome Measure Information:
Title
Duration of plasmatic asparagin depletion (< 2µmol/l)
Time Frame
PK points
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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:
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yves Bertrand, MD PhD
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Debrousse
City
Lyon
ZIP/Postal Code
69005
Country
France
12. IPD Sharing Statement
Learn more about this trial
Administration of Allogenic Red Blood Cells Loaded L-asparaginase in Cases of Relapse of Acute Lymphoblastic Leukaemia
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