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

• Conditions: acute lymphoblastic leukemia (including acute biphenotypic leukemia) in infants <1 year of age; MedDRA version: 8.1Level: LLTClassification code 10000845Term: Acute lymphoblastic leukemia

• Registration Number: EUCTR2005-004599-19-PT
• Lead Sponsor: Dutch Childhood Oncology Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05-05
• Last Update Posted: 17 July 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 450

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified