NCT00723346

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2006

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

July 24, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 28, 2008

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

January 11, 2012

Status Verified

January 1, 2012

Enrollment Period

2.6 years

First QC Date

July 24, 2008

Last Update Submit

January 10, 2012

Conditions

Acute Lymphoblastic Leukemia

Keywords

RelapseLymphoma lymphoblastic

Outcome Measures

Primary Outcomes (1)

  • Duration of plasmatic asparagin depletion (< 2µmol/l)

    PK points

Study Arms (4)

1

EXPERIMENTAL
Biological: GRASPA

2

EXPERIMENTAL
Biological: GRASPA

3

EXPERIMENTAL
Biological: GRASPA

4

ACTIVE COMPARATOR
Drug: native L asparaginase

Interventions

GRASPABIOLOGICAL

50 UI/Kg

1
native L asparaginaseDRUG

10000UI/m2, 14 infusions during 4 chemotherapy cycle

4

Eligibility Criteria

Age1 Year - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Debrousse

Lyon, 69005, France

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-LymphomaRecurrence

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Yves Bertrand, MD PhD

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2008

First Posted

July 28, 2008

Study Start

January 1, 2006

Primary Completion

August 1, 2008

Study Completion

March 1, 2009

Last Updated

January 11, 2012

Record last verified: 2012-01

Locations

FR(1)