ALL2008 Protocol for Childhood Acute Lymphoblastic Leukemia Intermittent Versus Continuous PEG Asparaginase
Acute Lymphoblastic Leukemia
About this trial
This is an interventional treatment trial for Acute Lymphoblastic Leukemia focused on measuring acute lymphoblastic leukemia, child, PEG-Asparaginase, EFS, efficacy, childhood acute lymphoblastic leukemia
Eligibility Criteria
Inclusion Criteria:
- Childhood ALL
- All mandatory biological data are available6
- Written informed consent has been obtained
Exclusion Criteria:
- Bilineage ALL
- Pre-treatment with glucocorticosteroids or other antileukemic agents for more than 1 week
- ALL predisposition syndromes
- Previous cancer
- Off protocol administration of additional chemotherapy during induction therapy
- Sexually active females not using contraception
- No allergic reactions to PEG Asparaginase
Sites / Locations
- Department of Pediatrics, Rigshospitalet
- Helsinki University Hospital
- University Hospital Reykjavik, Iceland
- Trondheim University Hospital
- Department of Pediatrics, Drottning Sylvias Pediatric Hospital
- NOPHO nordic organisation for pediatric onology
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
PEG-asparaginase 6 weeks intervals
PEG-Asparaginase 2 weeks intervals
PEG-asparaginase (1.000 IU/m2/dose) given at six weeks intervals (from week 13 after diagnosis to week 33). All additional therapy (High Dose Methotrexate, Vincristin, Dexamethasone, 6-Mercaptopurine, doxorubicin, intrathecal chemotherapy) is the same in both arms.
PEG-asparaginase (1.000 IU/m2/dose) given at two weeks intervals (from week 13 after diagnosis to week 33). All additional therapy (High Dose Methotrexate, Vincristin, Dexamethasone, 6-Mercaptopurine, doxorubicin, intrathecal chemotherapy) is the same in both arms.