Comparative efficacy and safety of two asparaginase preparations in children with previously untreated acute lymphoblastic leukaemia - Comparative efficacy and safety of two asparaginase preparations in children with de novo 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
- EUCTR2006-003180-31-NL
- Lead Sponsor
- medac GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- Not specified
- Previously untreated T-lineage or precursor B-lineage ALL
- Patients must have morphological proof of ALL and diagnosis must be
made from bone marrow morphology with ? 25% blasts
- Age 1 year to 18 years
- Written informed consent
- Treatment according to DCOG ALL 10 protocol
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
- Patients with secondary ALL
- Known allergy to any ASNase preparation
- General health status according to Karnofsky / Lansky score < 40%
- Pre-existing known coagulopathy (e.g. haemophilia)
- Pre-existing pancreatitis
- Liver insufficiency (Bilirubin > 50 µmol/L; SGOT/SGPT > 10 x ULN)
- Other current malignancies
- Pregnancy (planned or existent), breast feeding
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