Back to results

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

native L asparaginase

About this trial

This is an interventional treatment trial for Acute Lymphoblastic Leukemia focused on measuring Relapse, Lymphoma lymphoblastic

Eligibility Criteria

1 Year - 55 Years (Child, Adult)All SexesDoes not accept 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)

Exclusion Criteria:

Sites / Locations

Hopital Debrousse

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Arm Label

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

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Arm Title

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

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

We'll reach out to this number within 24 hrs