International Study for Treatment of High Risk Childhood Relapsed ALL 2010

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.

Conditions

• Acute Lymphoblastic Leukemia (ALL)

Interventions

DRUG

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.

Sponsors & Collaborators

• Australian & New Zealand Children's Haematology/Oncology Group

  collaborator OTHER

• St. Anna Kinderkrebsforschung, CCRI (co-sponsor, Austria)

  collaborator UNKNOWN

• European Organisation for Research and Treatment of Cancer - EORTC

  collaborator NETWORK

• University Hospital, Motol

  collaborator OTHER

• Rigshospitalet, Denmark

  collaborator OTHER

• Turku University Central Hospital (co-sponsor, Finland)

  collaborator UNKNOWN

• Centre Hospitalier Universitaire de Nice

  collaborator OTHER

• Our Lady's Chilrden's Hospital (Co-Sponsor Ireland)

  collaborator UNKNOWN

• Tel Aviv Sourasky Medical Centre (Co-Sponsor Israel)

  collaborator UNKNOWN

• Ospedale Pediatrico Bambino (co-sponsor, Italy)

  collaborator UNKNOWN

• Prinses Máxima Centrum (Co-Sponsor Netherlands)

  collaborator UNKNOWN

• Oslo University Hospital (co-sponsor, Norway)

  collaborator UNKNOWN

• Medical University of Wroclaw (Co-Sponsor Poland)

  collaborator UNKNOWN

• Instituto Português de Oncologia de Lisboa (co-sponsor, Portugal)

  collaborator UNKNOWN

• Karolinska University Hospital Stockholm (co-sponsor, Sweden)

  collaborator UNKNOWN

• Spanish Society of Pediatric Hematology and Oncology (SEHOP) (Co-Sponsor Spain)

  collaborator UNKNOWN

• University Children's Hospital, Zurich

  collaborator OTHER

• Central Manchester University Hospitals NHS Foundation Trust (co-sponsor, UK)

  collaborator UNKNOWN

• Charite University, Berlin, Germany

  lead OTHER

Principal Investigators

• Arend von Stackelberg, MD · Charite University, Berlin, Germany

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-09-01

Primary Completion

2027-12-31

Completion

2027-12-31

Countries

• Australia
• Austria
• Belgium
• Czechia
• Denmark
• Finland
• France
• Israel
• Italy
• Netherlands
• Norway
• Poland
• Portugal
• Sweden
• United Kingdom

Study Locations