Interfant Registry

Acute lymphoblastic or biphenotypic acute leukemia in infants under one year

Registry

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.

• 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.

• 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.