International Study for Treatment of High Risk Childhood Relapsed ALL 2010

NCT03590171 | Recruiting Phase 2 DMC

• 1 other identifier: IntReALL HR 2010
• Study Type: interventional
• Target: 250
• Locations: 14 countries
• Sites: 14

Brief 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)

Keywords

ALL

Outcome Measures

Primary Outcomes (1)

• Rate of Complete Remission

  Rate of complete second remission (CR2) quantified by cytology after induction with standard chemotherapy + bortezomib (arm B) compared with standard chemotherapy (arm A).

  Week 4

Secondary Outcomes (7)

• Event-free Survival

  Year 3

• Overall Survival

  Year 3

• Minimal Residual Disease Reduction (MRD)

  Week 4

• Minimal Residual Disease Load

  Week 15

• Minimal Residual Disease (MRD)

  Week 15

Other Outcomes (3)

• Minimal Residual Disease in Isolated Extramedullary Relapse

  Day 0; Week 5, 8, 11, 15

• Extended Genetic Characterization

  Day 0

• In-vitro drug response profile

  Day 0

Study Arms (2)

Arm HR-A

NO INTERVENTION

Induction: Backbone ALL R3

Arm HR-B

EXPERIMENTAL

Induction: Backbone ALL R3 + Bortezomib

Drug: Bortezomib

Interventions

Bortezomib DRUG

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.

Arm HR-B

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Morphologically confirmed diagnosis of 1st relapsed precursor B-cell or T-cell ALL
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• Australian & New Zealand Children's Haematology/Oncology Group: collaborator
• St. Anna Kinderkrebsforschung, CCRI (co-sponsor, Austria): collaborator
• European Organisation for Research and Treatment of Cancer - EORTC: collaborator
• University Hospital, Motol: collaborator
• Rigshospitalet, Denmark: collaborator
• Turku University Central Hospital (co-sponsor, Finland): collaborator
• Centre Hospitalier Universitaire de Nice: collaborator
• Our Lady's Chilrden's Hospital (Co-Sponsor Ireland): collaborator
• Tel Aviv Sourasky Medical Centre (Co-Sponsor Israel): collaborator
• Ospedale Pediatrico Bambino (co-sponsor, Italy): collaborator
• Prinses Máxima Centrum (Co-Sponsor Netherlands): collaborator
• Oslo University Hospital (co-sponsor, Norway): collaborator
• Medical University of Wroclaw (Co-Sponsor Poland): collaborator
• Instituto Português de Oncologia de Lisboa (co-sponsor, Portugal): collaborator
• Karolinska University Hospital Stockholm (co-sponsor, Sweden): collaborator
• Spanish Society of Pediatric Hematology and Oncology (SEHOP) (Co-Sponsor Spain): collaborator
• University Children's Hospital, Zurich: collaborator
• Central Manchester University Hospitals NHS Foundation Trust (co-sponsor, UK): collaborator

Study Sites (15)

Australian & New Zealand Childhood Hematology & Oncology Group

Clayton, Victoria, 3168, Australia

RECRUITING

St. Anna Kinderkrebsforschung, CCRI

Vienna, 1090, Austria

RECRUITING

Hòpital Universitaire des Enfants Reine Fabiola

Brussels, 1020, Belgium

RECRUITING

University Hospital Motol

Prague, Czechia

RECRUITING

Copenhagen University Hospital (Rigshospitalet)

Copenhagen, 2100, Denmark

NOT YET RECRUITING

Turku University Central Hospital

Turku, SF-20520, Finland

RECRUITING

CHU Nice

Nice, France

RECRUITING

Tel Aviv Sourasky Medical Centre

Tel Aviv, 64239, Israel

RECRUITING

Ospedale Pediatrico Bambino Gesù

Roma, 00165, Italy

RECRUITING

Prinses Máxima Centrum, Lundlaan

Utrecht, Netherlands

RECRUITING

Oslo University Hospital

Oslo, 0027, Norway

NOT YET RECRUITING

Dpt. SCT and Hematology/Oncology University Wroclaw

Wroclaw, 50354, Poland

RECRUITING

Instituto Português de Oncologia de Lisboa

Lisbon, Portugal

NOT YET RECRUITING

University Hospital Stockholm

Stockholm, 17176, Sweden

NOT YET RECRUITING

Royal Manchester Children's Hospital

Manchester, M13 9WL, United Kingdom

NOT YET RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Bortezomib

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Organic Chemicals; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Arend von Stackelberg, MD

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arend von Stackelberg, MD

CONTACT

+49(0)30-450666; arend.stackelberg@charite.de

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator

Study Record Dates

• First Submitted: May 23, 2018
• First Posted: July 18, 2018
• Study Start: September 1, 2017
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 17, 2026

Record last verified: 2026-03

Locations

SE (1); DK (1); FI (1); PT (1); IL (1); PL (1); BE (1); IT (1); CZ (1); AU (1); NL (1); FR (1); NO (1); GB (1)