Interfant Registry

Author:  Anja Möricke, Julia Dobke, erstellt am 2019/06/19, Last modification:  2021/02/05

Interfant Registry

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

Stratification into 3 risk groups Low risk (LR), Medium Risk (MR) and High risk (HR), will be based upon the MLL status, age and WBC/prednisone response. The LR group will consist of all MLL germline cases, including MLL germline patients with a PPR. Determining the MLL status by split signal FISH in Interfant-06 will be mandatory for participating groups.

Criteria for HR patients are those:
1. who are MLL rearranged,
2. and < 6 months and
3 . have either a WBC ≥ 300 or a prednisone poor response.
MR patients are all others.

All patients receive the standard arm.
Alle Patienten der HR-Gruppe sowie Patienten der MR-Gruppe mit Nachweis minimaler Resterkrankung (MRD) von 10-4 bei Start des Therapieelementes OCTDAD sind für eine allogene Stammzelltransplantation qualifiziert, deren Durchführung nach dem Therapieelement MARMA, also vor OCTADAD oder während OCTADAD angestrebt werden sollte. Für Spenderauswahl, Konditionierung und GVHD-Prophylaxe wird auf die jeweils aktuelle Fassung des Protokolls ALL SCTped Forum 2012 verwiesen.

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 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)
Sponsoring Deutsche Krebshilfe