Comparative pharmacokinetics, pharmacodynamics, efficacy and safety of two asparaginase preparations in children with previously untreated acute lymphoblastic leukaemia (ALL)

Completed

• Conditions: Acute lymphoblastic leukaemia (ALL); Cancer; Lymphoid leukaemia

• Registration Number: ISRCTN75734403
• Lead Sponsor: Medac GmbH (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01-27
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

1. Previously untreated ALL
2. Morphological proof of ALL; bone marrow greater than 25% blasts
3. Aged 1 - 18 years
4. Informed consent

Exclusion Criteria

1. Known allergy to ASNase
2. General health status according to Karnofsky/Lansky less than 40%
3. Pre-existing coagulopathy (e.g. haemophilia)
4. Pre-existing pancreatitis
5. Kidney insufficiency (creatinine greater than 220 umol/l)
6. Liver insufficiency (bilirubin greater than 50 umol/l; aspartate aminotransferase [ASAT] and alanine aminotransferase [ALAT] greater than 5 x upper limit of normal
7. Other current malignancies
8. Pregnancy, breast feeding
9. Patients suffering from mental disorders

Study & Design

• Study Type: Interventional
• Study Design: Not specified