Morphologically confirmed diagnosis of 1st relapsed precursor B-cell or T-cell ALL
Conditions
Interventions
SR armA (ALL-REZ BFM 2002 ,arm Prot II-IDA)
SR arm B (UK-R3, arm mitoxantrone)
Sponsors
Japanese pediatric leukemia/Lymphoma Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Morphologically confirmed diagnosis of 1st relapsed precursor B-cell or T-cell ALL. Children less than 18 years of age at inclusion. Meeting SR criteria: late isolated or late/early combined BCP BM relapse, any late/early isolated extramedullary relapse. Patient enrolled in a participating centre. Written informed consent. Start of treatment falling into the study period. No participation in other clinical trials 30 days prior to study enrolment that interfere with this protocol, except trials for primary ALL.
Exclusion criteria
Exclusion criteria: BCR-ABL / t(9;22) positive ALL. Pregnancy or positive pregnancy test (urine sample positive for beta-HCG > 10 U/l). Sexually active adolescents not willing to use highly effective contraceptive method (pearl index < 1) until 2 years after end of antileukemic therapy. Breast feeding. Relapse post allogeneic stem-cell transplantation. The whole protocol or essential parts are declined either by patient himself/herself or the respective legal guardian. No consent is given for saving and propagation of pseudonymized medical data for study reasons. Severe concomitant disease that does not allow treatment according to the protocol at the investigator's discretion (e.g. malformation syndromes, cardiac malformations, metabolic disorders). Karnovsky / Lansky score < 50%. Subjects unwilling or unable to comply with the study procedures. Subjects who are legally detained in an official institute.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event free survival (EFS) | — |
Countries
Japan,Australia,Europe
Contacts
Public ContactHidemi Toyoda
Mie University, School of medicine Deaprtment of Paediatrics
Outcome results
None listed