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

Dutch Childhood Oncology Group0 sites445 target enrollmentOctober 17, 2007

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: acute lymphoblastic leukemia (including acute biphenotypic leukemia) in infants <1 year of age
Sponsor: Dutch Childhood Oncology Group
Enrollment: 445
Status: Active, not recruiting
Last Updated: 2 years ago

No summary available.

Registry

who.int

Start Date

October 17, 2007

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Dutch Childhood Oncology Group

•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.
•4\. Mandatory guidelines as per Amendment 23 May 2012\.
•5\. An amendment to the Stem Cell Transplantation (SCT) regimen was made on the 23 May 2012 because of the high SCT related mortality.
•5\.a The SCT conditioning regimen Busulfan Cyclofosfamide\-Melphalan will be replaced by the less toxic conditioning regimen iv Busulfan (or Treosulfan), Fludarabine and Thiotepa.
•5\.b. It is advised to refer infant Acute Lymphoblastic Leukemia (ALL) cases to SCT to large experienced transplant centers.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 445
•F.1\.2 Adults (18\-64 years) no

•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.
•6\. HR patients who have MRD level of \<10e\-4 by PCR at the start of OCTADA(D) will not be eligible for mismatched donor transplant.