Ireland
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Recruiting Phase 2

International Study for Treatment of High Risk Childhood Relapsed ALL 2010

NCT03590171 · tracked via the Priya Life Science Sweden tracker
Phase
Phase 2
Started
2017-09-01
Last updated
2026-03-17

Condition(s) studied

Acute Lymphoblastic Leukemia (ALL)

Investigational drug(s) / intervention(s)

Bortezomib →

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)

FacilityCityRegionStatus
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 Sweden

Official registry record

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.

View NCT03590171 on ClinicalTrials.gov ↗ ← All trials in Sweden