INTERFANT-06.International collaborative treatment protocol for infants under one year of age with acute lymphoblastic or biphenotypic leukemia.

the different international study groups0 个研究点目标入组 445 人开始时间: 待定最近更新: 2024年2月28日

试验速览

•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.

•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.

发起方

the different international study groups