EUCTR2005-004599-19-FR
Active, not recruiting
Phase 1
International collaborative treatment protocol for infants under one year with acute lymphoblastic or biphenotypic leukemia - INTERFANT 06
Dutch Childhood Oncology Group0 sites450 target enrollmentDecember 17, 2007
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Dutch Childhood Oncology Group
- Enrollment
- 450
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) no
- •F.1\.2\.1 Number of subjects for this age range
- •F.1\.3 Elderly (\>\=65 years) no
- •F.1\.3\.1 Number of subjects for this age range
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.
Outcomes
Primary Outcomes
Not specified
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