ACTRN12611001233910Active, not recruitingPhase 3
An international collaborative (AIEOP-BFM [Associazione Italiana Ematologia Oncologia Pediatrica - Berlin-Franklin-Munster]) treatment protocol for children and adolescents with Acute Lymphoblastic Leukaemia
Australian and New Zealand Children's Haematology/Oncology Group0 sites6,178 target enrollmentStarted: December 2, 2011Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Active, not recruiting
- Enrollment
- 6,178
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Open (masking not used)
Eligibility Criteria
- Ages
- 365 Days to 18 Years (—)
- Sex
- All
Inclusion Criteria
- •Patients meeting all:
- •- newly diagnosed acute lymphoblastic leukemia
- •- no Ph+ (BCR/ABL or t(9;22)-positive) ALL
- •- no evidence of pregnancy or lactation period
- •- no participation in another study
- •- patient enrolled in participating centre
- •- written informed consent
Exclusion Criteria
- •Patients meeting any of the following will not be eligible and will be analysed seperately:
- •- pre-treatment with cytostatic drugs
- •- steroid pre-treatment with >/= 1mg/kg/d for more than two weeks during the last month before diagnosis
- •- treatment started according to another protocol
- •- underlying diseases that prohibit treatment according to the protocol
- •- ALL diagnosed as second malignancy
Investigators
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