International collaborative treatment protocol for Infants under one year with Acute Lymphoblastic or Biphenotypic Leukemia

Phase 1

• Conditions: Infant Acute lymphoblastic leukemia (ALL) or biphenotypic leukemia; MedDRA version: 20.0Level: LLTClassification code 10067837Term: Acute biphenotypic leukemiaSystem Organ Class: 100000004864; MedDRA version: 20.1Level: LLTClassification code 10000844Term: Acute lymphoblastic leukaemiaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-10
• Last Update Posted: 29 January 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 445

Inclusion Criteria

The criteria for entry to the study are:
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.
(It is important that all infants with ALL less than 1 year of age, including those infants who are eligible but are not treated according to the protocol are registered so that any selection bias can be determined.)
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

Patients are excluded from the study if at least one of the following exclusion criteria applies:
1. Mature-B ALL without MLL rearrangement, characterized by surface immunoglobulines or by 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.
6. Hypersensitivity to any investigational drugs (medicines)

Study & Design

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