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Efficacy and Safety of Recombinant Asparaginase in Infants (<1 Year) With Previously Untreated Acute Lymphoblastic Leukaemia - Phase II Clinical Trial


Phase 2
N/A
364 Days
Not Enrolling
Both
Acute Lymphoid Leukemia

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Trial Information

Efficacy and Safety of Recombinant Asparaginase in Infants (<1 Year) With Previously Untreated Acute Lymphoblastic Leukaemia - Phase II Clinical Trial


Inclusion Criteria:



- Previously untreated T-lineage or precursor B-lineage ALL or biphenotypic leukaemia
according to EGIL criteria.

- Morphological verification of the diagnosis, confirmed with cyto¬chemistry and
immunophenotyping.

- Age < 1 year at diagnosis.

- Written informed consent of the parents or other legally authorised guardian of the
patient.

- Treatment according to protocol INTERFANT 06

Exclusion Criteria:

- Mature B-lineage ALL, defined by the immunophenotypical presence of surface
immunoglobulins or t(8;14) and breakpoint as in B-ALL.

- The presence of the t(9;22)(q34;q11) or bcr-abl fusion in the leukaemic cells.

- Systemic use of corticosteroids less than 4 weeks before diagnosis. Patients who
received corticosteroids by aerosol are eligible.

- Known allergy to any ASNase preparation.

- Pre-existing known coagulopathy (e.g. haemophilia).

- Pre-existing pancreatitis.

- Liver insufficiency (bilirubin > 50 µmol/L; SGOT/SGPT > 10 x the upper limit of
normal).

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

number of patients with hypersensitivity reactions to rASNase

Outcome Time Frame:

within 2 months

Safety Issue:

Yes

Principal Investigator

Rob Pieters, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Erasmus MC-Sophia Children's Hospital

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

MC-ASP.6/INF

NCT ID:

NCT00983138

Start Date:

July 2009

Completion Date:

February 2011

Related Keywords:

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

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