Internationale Studie zur Behandlung von rezidivierender ALL 2010 mit Standard-Risiko bei Kindern

Drug: SR-A + Epratuzumab;Drug: SR-B + Epratuzumab

Gender: All
Maximum age: 17 Years
Minimum age: 1 Day

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 B-cell precursor (BCP) bone
marrow (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 Inclusion criteria
specific for the epratuzumab randomization

- Precursor B-cell immunophenotype. A specific CD22 expression level is not required

- M1 or M2 status of the bone marrow after induction

Exclusion Criteria:

- BCR-ABL / t(9;22) positive ALL

- Pregnancy or positive pregnancy test (urine sample positive for ?-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