None listed
Conditions
Interventions
Comparison of early intensification of two "AML" induction blocks versus protocol Ib directly after induction, in a randomized way in medium risk and high risk patients.
Sponsors
the different international study groups
Eligibility
Inclusion criteria
Inclusion criteria: 1. Children aged 365 days or less with newly diagnosed acute lymphoblastic leukemia (ALL) or biphenotypic leukemia according to EGIL criteria. Children with 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.
Exclusion criteria
Exclusion criteria: 1. Mature 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 these data are not known, the patient is eligible); 3. Age > 365 days; 4. Relapsed ALL; 5. Systemic use of corticosteroids less than 4 weeks before diagnosis. Patients who received corticosteroids by aerosol are eligible for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event free survival. | — |
Secondary
| Measure | Time frame |
|---|---|
| Survival. | — |
Contacts
Public ContactRob Pieters
Erasmus Medical Center, Sophia Children's Hospital, Department of Oncology/Hematology, P.O. Box 2060
Outcome results
None listed