Administration of Allogenic Red Blood Cells Loaded L-aspa... | NCT00723346

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

NCT00723346

Sponsor

ERYtech Pharma

Status

Completed

Last Update Posted

Jan 11, 2012Estimated

Enrollment

25Actual

Phase

Phase 1Phase 2

Conditions

Acute Lymphoblastic Leukemia

Interventions

GRASPA
GRASPA
GRASPA
native L asparaginase

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2006

Primary Completion Date

Aug 2008Actual

Completion Date

Mar 2009Actual

First Submitted Date

Jul 24, 2008

First Submission Date that Met QC Criteria

Jul 25, 2008

First Posted Date

Jul 28, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 10, 2012

Last Update Posted Date

Jan 11, 2012Estimated

Name	Class
Centre Leon Berard	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
1	Experimental	Biological: GRASPA
2	Experimental	Biological: GRASPA
3	Experimental	Biological: GRASPA
4	Active Comparator	Drug: native L asparaginase

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GRASPA	Biological	50 UI/Kg	1
GRASPA

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

55 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yves Bertrand, MD PhD	Hospices Civils de Lyon	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hopital Debrousse		Lyon		69005	France

Condition Browse Module

MeSH Terms

ID	Term
D054198	Precursor Cell Lymphoblastic Leukemia-Lymphoma
D012008	Recurrence

Ancestor Terms

ID	Term
D007945	Leukemia, Lymphoid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided