Interfant 06

Phase 1

• Conditions: Acute lymphoblastic leukaemia; MedDRA version: 18.0Level: LLTClassification code 10000844Term: Acute lymphoblastic leukaemiaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2005-004599-19-GB
• Lead Sponsor: niversity of Birmingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-01-29
• Last Update Posted: 13 October 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

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.
Are the trial subjects under 18? yes
Number of subjects for this age range: 75
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

Patients are excluded from the study if at least one of the following exclusion criteria applies:
Mature B-ALL, defined by the immunophenotypical presence of surface immunoglobulines or t(8;14) and breakpoint as in B-ALL.
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).
Age > 365 days.
Relapsed ALL.
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