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


Phase 1/Phase 2
1 Year
55 Years
Not Enrolling
Both
Acute Lymphoblastic Leukemia

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Trial Information

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


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:

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

PK points

Safety Issue:

No

Principal Investigator

Yves Bertrand, MD PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hospices Civils de Lyon

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

GRASPALL 2005-01

NCT ID:

NCT00723346

Start Date:

January 2006

Completion Date:

March 2009

Related Keywords:

  • Acute Lymphoblastic Leukemia
  • Relapse
  • Lymphoma lymphoblastic
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma

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