Efficacy and safety of recombinant asparaginase in infants (< 1 year) with previously untreated acute lymphoblastic leukaemia - Phase II Clinical Trial - - Efficacy and safety of recombinant asparaginase in infants with previously untreated A

medac Gesellschaft für klinische Spezialpräparate mbH0 个研究点目标入组 12 人开始时间: 2009年2月17日最近更新: 2012年3月19日

试验速览

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•-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. In case a bone marrow aspiration results in a dry tap”, a trephine biopsy is advised unless it is possible to confirm the diagnosis by peripheral blood examination.
•- 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 (EudraCT number 2005-004599-19)
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•-Mature B-lineage ALL, defined by the immunophenotypical presence of surface immunoglobulines 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 (if these data are not known, the patient is eligible).
•- 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).

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