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
- Conditions
- Acute lymphoblastic leukaemia (ALL) is a clonal disease resulting from genetic mutations and transformation of a single early progenitor lymphoid cell. Uncontrolled expansion of leukaemic blasts in the bone marrow leads to suppression of normal haematopoiesis as well as disseminated infiltration of organs and release of blasts into periphal blood.MedDRA version: 9.1Level: LLTClassification code 10000844Term: Acute lymphoblastic leukaemia
- Registration Number
- EUCTR2008-006300-27-DE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 12
-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).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method