International collaborative treatment protocol for Infants under one year with Acute Lymphoblastic or Biphenotypic Leukemia - Interfant-06

Dutch Childhood Oncology Group0 sites445 target enrollmentJanuary 10, 2014

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Infant Acute lymphoblastic leukemia (ALL) or biphenotypic leukemia
Sponsor: Dutch Childhood Oncology Group
Enrollment: 445
Status: Active, not recruiting
Last Updated: 8 years ago

No summary available.

Registry

who.int

Start Date

January 10, 2014

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Dutch Childhood Oncology Group

•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

•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)