International collaborative treatment protocol for infants under age one with acute lymphoblastic or biphenotypic leukemia
- Conditions
- Biphenotypic leukemia, acute lymphoblastic leukemia (ALL)CancerAcute lymphoblastic, biphenotypic leukemia
- Registration Number
- ISRCTN12500962
- Lead Sponsor
- Stichting Kinder Oncologie (SKION) (The Netherlands)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 445
1. Children aged 365 days or less with newly diagnosed acute lymphoblastic leukemia (ALL) or biphenotypic leukemia according to European Group for the Immunological Classification of Leukemia (EGIL) criteria. Children with central nervous system (CNS) or testicular leukemia at diagnosis are eligible
2. Morphological verification of the diagnosis, confirmed with cytochemistry 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.
3. Informed consent of the parents or other legally authorized guardian of the patient
1. Mature B-cell acute lymphoblastic leukemia (B-ALL), defined by the immunophenotypical presence of surface immunoglobulines or t(8;14) and breakpoint as in B-ALL
2. The presence of the t(9;22) (q34;q11) or bcr-abl fusion in the leukemic cells (if this data is not known, the patient is eligible)
3. Age >365 days
4. Relapsed ALL
5. Systemic use of corticosteroids less than four weeks before diagnosis. Patients who have received corticosteroids by aerosol are eligible for the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Event-free survival
- Secondary Outcome Measures
Name Time Method Survival