Bortezomib: Patients randomised to the HR-B arm receive induction, consolidation with the modified ALL R3 protocol. In this arm, patients are randomized to receive Bortezomib together with the ALL R3 protocol during induction. Administration of Bortezomib: 1.3 mg/m2 as intravenous bolus or subcutaneously (SC, at the discretion of the treating physician) on days 1 and 4 of weeks 1 and 3.
Study summary
The main goal of this study is to improve the outcome of children and adolescents with acute lymphoblastic leukemia with high risk first relapse by optimization of treatment strategies within a large international trial and the integration of new agents.
Eligibility
Sex
ALL
Min age
—
Max age
17 Years
Healthy volunteers
No
Inclusion Criteria:
* Morphologically confirmed diagnosis of 1st relapsed precursor B-cell or T-cell ALL
* Children less than 18 years of age at date of inclusion into the study
* Meeting HR criteria any BM relapse, early/very early isolated BM relapse, very early isolated/combined 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 day prior to study enrolment that interfere with this protocol, except trials for primary ALL
Exclusion Criteria:
* Breakpoint cluster region-Abelson (BCR-ABL)/ t(9;22) positive ALL
* Pregnancy or positive pregnancy test (urine sample positive for β-humane choriongonadotropin (HCG) \> 10 U/l)
* Sexually active adolescents not willing to use highly effective contraceptive method (pearl index \<1) until 12 months after end of anti-leukemic therapy
* Breast feeding
* Relapse post allogeneic stem-cell transplantation
* Neuropathy \> II°
* The whole protocol or essential parts are declined either by patient himself/herself or the respective legal guardian
* Objection to the study participation by a minor patient, able to object
* Any patient being dependent on the investigator
* 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
Primary outcome measure(s)
Rate of Complete Remission — Week 4 Rate of complete second remission (CR2) quantified by cytology after induction with standard chemotherapy + bortezomib (arm B) compared with standard chemotherapy (arm A).
Trial sites (15)
Facility
City
Region
Status
Australian & New Zealand Childhood Hematology & Oncology Group
Clayton
Victoria
Recruiting
St. Anna Kinderkrebsforschung, CCRI
Vienna
Austria
Recruiting
Hòpital Universitaire des Enfants Reine Fabiola
Brussels
Belgium
Recruiting
University Hospital Motol
Prague
Czechia
Recruiting
Copenhagen University Hospital (Rigshospitalet)
Copenhagen
Denmark
Not Yet Recruiting
Turku University Central Hospital
Turku
Finland
Recruiting
CHU Nice
Nice
France
Recruiting
Tel Aviv Sourasky Medical Centre
Tel Aviv
Israel
Recruiting
Ospedale Pediatrico Bambino Gesù
Roma
Italy
Recruiting
Prinses Máxima Centrum, Lundlaan
Utrecht
Netherlands
Recruiting
Oslo University Hospital
Oslo
Norway
Not Yet Recruiting
Dpt. SCT and Hematology/Oncology University Wroclaw
Wroclaw
Poland
Recruiting
Instituto Português de Oncologia de Lisboa
Lisbon
Portugal
Not Yet Recruiting
University Hospital Stockholm
Stockholm
Sweden
Not Yet Recruiting
Royal Manchester Children's Hospital
Manchester
United Kingdom
Not Yet Recruiting
More Charite University, Berlin, Germany trials in Poland
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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