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INTREALL — Result In Brief

Project ID: 278514
Funded under: FP7-HEALTH
Country: Germany

International cooperation for ALL disease solutions

Acute lymphoblastic leukaemia (ALL) is a malignant cancer characterised by over-production of white blood cells that predominantly affects children, with fatal relapse in some patients. An EU-funded project is investigating novel therapies for ALL.
International cooperation for ALL disease solutions
Relapse of ALL is currently treated with intensive chemotherapy and haematopoietic stem cell transplantation (HSCT), and over the decades, survival prognosis has improved. New drugs that are potentially more beneficial with fewer toxic side-effects need to be tested prior to licensing approval for commercial application. However, incidence of relapsed ALL cases are too few and international collaboration is needed for a successful clinical trial and accurate data analysis.

The EU-funded INTREALL project is comprised of several European and international study groups with expertise in childhood cancers. INTREALL will facilitate an international clinical trial on childhood relapsed ALL with global collaboration between hospitals and innovative small and medium-sized enterprises (SMEs). Efforts will be made to optimise treatment strategies by investigating standard as well as innovative therapies in compliance with good clinical practices (GCPs).

Consortium members laid the groundwork for implementation of the clinical trial INTREALL 2010 to investigate ALL relapse in children. Treatment strategies will be based on risk stratification of patients into standard-risk (SR) and high-risk (HR) categories. Requisite protocols, statistical plans, approvals, databases and infrastructural setups are in progress for the SR and HR groups of clinical trials.

For SR patients, the two most successful treatment protocols in practice will be compared. Some SR patients will also be treated with Epratuzumab, a humanised monoclonal antibody that binds to glycoprotein CD22 on cancerous cells. A treatment course of clofarabine combined with cyclophosphamide or etoposide will be tested on HR patients.

For the assessment of treatment outcomes, diagnostic procedures were standardised along with quality control strategies. Test protocols for studying disease pathogenesis, new risk factors and targets for new drugs were also set up along with a virtual tissue bank. Pilot studies established the sensitivity and specificity of pooling technology for deep sequencing of candidate genes.

INTREALL initiatives will provide comprehensive data on ALL. Results will serve as a reference for determining treatment strategies and monitoring patient progress as well as for future ALL clinical trials. Due to the rareness of ALL, clinical trials will provide unprecedented opportunities to test the efficacy of promising new drugs such as Epratuzumab. Project outcomes could reveal novel treatment options that could personalise care for ALL patients to improve prognosis and quality of life.

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