Interfant Registry

Author: Anja Möricke, Julia Dobke, erstellt am: 2019/06/19, Last modification: 2019/09/17

Title International collobarative treatment protocol for infants under one year with acute lympohoblastic or biphenotypic leukemia
Disease Acute lymphoblastic or biphenotypic acute leukemia in infants under one year
Type Registry
Therapy / Study arms
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. 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
  • 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.
  • Informed consent of the parents or other legally authorized guardian of the patient.
Exclusion Criteria
  • 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.
Recruitment unlimited
Status open
EudraCT 2005-004599-19
Entry Study Register National Cancer Institute: Protocol ID NCT00550992
Principal Investigator Prof. Dr. Rob Pieters (Rotterdam), Sponsor: Dutch Childhood Oncology Group (DCOG)
E-Mail mailto:all-bfm-studie@pediatrics.uni-kiel.de
URL all-bfm-studie@pediatrics.uni-kiel.de
Contact

National Coordinator and study chair for Germany

Prof. Dr. med. Martin Schrappe
Univ.-Klinikum Schleswig-Holstein, Campus Kiel
Klinik für Kinder- und Jugendmedizin I
Arnold-Heller-Str. 3
24105 Kiel
Telefon +49 (431) 500 20102
Fax +49 (431) 500 20104
m.schrappe@pediatrics.uni-kiel.de

Study Coordination

Dr. med. Anja Möricke
Univ.-Klinikum Schleswig-Holstein, Campus Kiel
Klinik für Kinder- und Jugendmedizin I, AIEOP-BFM ALL Studienzentrale
Arnold-Heller-Straße 3
24105 Kiel
Telefon +49 (431) 500 20150
Fax +49 (431) 500 20144
a.moericke@pediatrics.uni-kiel.de

Documentation

Katja Schulte
Univ.-Klinikum Schleswig-Holstein, Campus Kiel
Klinik für Kinder- und Jugendmedizin I, AIEOP-BFM ALL Studienzentrale
Arnold-Heller-Straße 3
24105 Kiel
Telefon +49 (431) 500 2147
Fax +49 (431) 500 20144
k.schulte@pediatrics.uni-kiel.de

Participants DCOG (the Netherlands) BFM-G (Germany) AIEOP (Italy) ANZCHOG (Australia, New Zealand) Argentina BFM-A (Austria) CLCG (France, Belgium, Portugal) COALL (Germany) CPH (Czech Republic) DFCI consortium (USA) FRALLE (France) Hong Kong MD Anderson (USA) NOPHO (Scandinavian countries) PINDA (Chile) PPLLSG (Poland) Seattle (USA) SJCRH (USA) UKCCSG (United Kingdom)
Link(s) Studienliteratur ALL
Sponsoring Deutsche Krebshilfe