Project description
Personalising childhood leukaemia treatment
Relapse of acute lymphoblastic leukaemia (ALL) is a significant factor contributing to childhood cancer mortality. The EU-funded IntReALL 2020 project has a primary objective: to replace toxic chemotherapy with more effective and better-tolerated immunotherapeutic drugs for children dealing with relapsed B-cell precursor (BCP) ALL. This will be accomplished through randomised trials and historical controlled trials. For standard-risk patients with acute ALL, the project will randomly compare a CD22-directed antibody-drug conjugate known as inotuzumab ozogamicin (InO) with the standard-of-care (SOC) induction therapy ALL-R3. All patients will receive one SOC consolidation and one Blina course, which will be assessed against historical controls. IntReALL 2020 will then leverage clinical and genetic data to personalise treatments.
Objective
Relapse of acute lymphoblastic leukemia (ALL) remains a leading cause of mortality in childhood cancer. IntReALL 2020 will conduct randomized and historically controlled trials in children with relapsed B-cell precursor (BCP) ALL with the aim to replace toxic chemotherapy with better tolerated and more efficacious immunotherapeutic drugs. In standard risk (SR) patients, the CD22 directed antibody-drug conjugate inotuzumab ozogamicin (InO) will be randomly compared with standard of care (SOC) ALL-R3 induction. All patients will receive one SOC consolidation- and one Blina course, compared to historical controls. SR patients with MRD good response will receive 2 additional Blina courses replacing chemotherapy randomly compared with SOC. Patients with high-risk relapse will receive induction investigating InO versus ALL-R3 in an industry-sponsored trial, followed by IntReALL consolidation and allogeneic HSCT. Patients with isolated extramedullary (IEM) relapse are treated based on ALL-REZ BFM 2002 backbone. IntReALL 2020 will establish a federated relapsed/refractory leukaemia board generating personalized recommendations based on clinical, molecular-genetic and drug response profiling data. Patients with very-high risk disease will receive experimental/personalized therapies, including a trial investigating CD19-directed chimeric receptor antigen (CAR) T-cells produced in academic institutions. Other CAR T-cells trials as well as an induction trial for T-ALL relapse will be developed. Documentation and monitoring of the trials and the individualized treatment will be realized using the MARVIN database. Comprehensive statistical and data management activities will warrant the accuracy and interpretability of the data. IntReALL 2020 involves representatives from participating pharmaceutical companies and EMA as well as patient/parent advocates to discuss strategies for developing new drugs within academic trials warranting a benefit for all patients on the results.
“This action is part of the Cancer Mission cluster of projects on ‘Diagnosis and treatment’.”
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Keywords
Programme(s)
- HORIZON.2.1 - Health Main Programme
Funding Scheme
HORIZON-RIA - HORIZON Research and Innovation ActionsCoordinator
10117 Berlin
Germany
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Participants (24)
06003 Nice
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00165 Roma
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3584CS Utrecht
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150 06 Praha 5
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30625 Hannover
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10117 BERLIN
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
115 27 ATHINA
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0450 Oslo
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022328 Bucuresti
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00029 Helsinki
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1094 Budapest
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9000 Gent
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3400 Hillerod
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1099 023 Lisboa
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64239 Tel Aviv
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30625 Hannover
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
1000 Ljubljana
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1090 Wien
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30120 Murcia
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Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.
30100 Murcia
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75012 Paris
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78100 Saint-Germain-En-Laye
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50 367 Wroclaw
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104 22 Stockholm
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Partners (1)
Partner organisations contribute to the implementation of the action, but do not sign the Grant Agreement.
8006 Zurich
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