RecruitingPhase 2NCT03590171

International Study for Treatment of High Risk Childhood Relapsed ALL 2010

International Study for Treatment of High Risk Childhood Relapsed ALL 2010 A Randomized Phase II Study Conducted by the Resistant Disease Committee of the International Berlin, Frankfurt, Münster (BFM) Study Group


Sponsor

Charite University, Berlin, Germany

Enrollment

250 participants

Start Date

Sep 1, 2017

Study Type

INTERVENTIONAL

Conditions

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

Max Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This international study develops and tests treatment plans for children whose acute lymphoblastic leukemia (ALL) — a type of blood cancer — has come back (relapsed) after initial treatment, focusing on high-risk cases where the cancer returned early or in the bone marrow. **You may be eligible if...** - You are a child under 18 years of age - You have been confirmed to have a first relapse of B-cell or T-cell ALL - Your case is classified as high-risk (for example: any relapse in the bone marrow, or very early isolated or combined relapse outside the bone marrow) - You are being treated at a participating center in the study - Written informed consent has been provided - You have not participated in another interfering clinical trial within 30 days of enrolling **You may NOT be eligible if...** - You are 18 years of age or older - Your cancer has relapsed more than once (this is for first relapses only) - You are currently enrolled in another clinical trial that conflicts with this protocol Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBortezomib

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.


Locations(15)

Australian & New Zealand Childhood Hematology & Oncology Group

Clayton, Victoria, Australia

St. Anna Kinderkrebsforschung, CCRI

Vienna, Austria

Hòpital Universitaire des Enfants Reine Fabiola

Brussels, Belgium

University Hospital Motol

Prague, Czechia

Copenhagen University Hospital (Rigshospitalet)

Copenhagen, Denmark

Turku University Central Hospital

Turku, Finland

CHU Nice

Nice, France

Tel Aviv Sourasky Medical Centre

Tel Aviv, Israel

Ospedale Pediatrico Bambino Gesù

Roma, Italy

Prinses Máxima Centrum, Lundlaan

Utrecht, Netherlands

Oslo University Hospital

Oslo, Norway

Dpt. SCT and Hematology/Oncology University Wroclaw

Wroclaw, Poland

Instituto Português de Oncologia de Lisboa

Lisbon, Portugal

University Hospital Stockholm

Stockholm, Sweden

Royal Manchester Children's Hospital

Manchester, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT03590171


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