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OpenTrials
Completed

NCT Number: NCT00723346

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

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

Completed

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Key information

Conditions

Acute Lymphoblastic Leukemia Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Precursor Cell Lymphoblastic Leukemia-Lymphoma Recurrence

Age range

1 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Hopital Debrousse

Lyon, 69005, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GRASPA

Biological

50 UI/Kg

native L asparaginase

Drug

10000UI/m2, 14 infusions during 4 chemotherapy cycle

Primary outcomes

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

    Time frame: PK points

Sponsors and collaborators

Lead sponsor

ERYtech Pharma

Industry

Collaborators

  • Centre Leon Berard

Registry information

Official study title

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

Acronym: GRASPALL

Important dates

Study start
2006
Primary completion
2008
Study completion
2009
First posted
Jul 28, 2008
Registry last updated
Jan 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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