International Study for Treatment of Standard Risk Childhood Relapsed ALL 2010

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 15

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

Inclusion criteria specific for the epratuzumab randomization: (Randomisation
closed 01-02-2019)
• 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 β-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)
•
• Subjects unwilling or unable to comply with the study procedures
• Subjects who are legally detained in an official institute

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary parameters:<br /><br>- Overall: Improvement of event-free survival (EFS) probabilities in childhood<br /><br>relapsed ALL<br /><br>- Randomization 1: EFS of Arm A (ALL-REZ BFM 2002) versus B (ALLR3) in SR<br /><br>patients<br /><br>- Randomization 2: Influence of epratuzumab on EFS in consolidation of SR [The<br /><br>2nd randomisation with/without Epratuzumab closed 01-02-2019]</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary parameters:<br /><br>- OS of Arm A (ALL-REZ BFM 2002) versus B (ALLR3) in SR patients<br /><br>- Influence of epratuzumab on OS in consolidation of SR patients<br /><br>- Rate of second complete remission (CR2) of Arm A versus Arm B<br /><br>- Rate of SCT performed in Arm A versus Arm B<br /><br>- Toxicity of randomized SR arms A versus B<br /><br>- Toxicity of consolidation with versus without epratuzumab<br /><br>- Improvement of MRD reduction during consolidation with versus without<br /><br>epratuzumab<br /><br>- Rate of MRD negativity prior to SCT with Arm A vs. Arm B<br /><br>- Rate of MRD negativity prior to SCT after consolidation with versus without<br /><br>epratuzumab<br /><br>- Pharmacokinetic of epratuzumab in context with arm A and arm B</p><br>