INTERFANT-06.International collaborative treatment protocol for infants under one year of age with acute lymphoblastic or biphenotypic leukemia.
- Registration Number
- NL-OMON20078
- Lead Sponsor
- the different international study groups
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 445
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.
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.