Zusammenfassung (Niederländisch oder Französisch oder Englisch)
Title | Eine klinische Studie für Kinder und junge Erwachsene mit akuter lymphoblastischer Leukämie (ALL) - ALLTogether-Studie1 |
Participants (P) |
Children and young adults with newly diagnosed acute lymphoblastic leukemia |
Intervention (I) |
R1: In low risk (VLR) patients tests whether therapy can be safely reduced by the randomised omission of Doxorubicin in the Delayed Intensification phase of treatment R2: In intermediate risk (IR-Low) patients with a low risk of relapse (IR-low) with standard IR-therapy tests if the therapy may be safely reduced by the randomised omission of either Doxorubicin in the Delayed Intensification phase of treatment or the omission of Vincristine(VCR)/Dexamethasone(Dexa) pulses in the Maintenance phase of treatment. R3: In a sub-population of IR patients with high risk of relapse (IR-high) tests if the relapse-risk can be reduced (and thereby the disease-free survival increased) by the randomised introduction of either two cycles a new agent (Inotuzumab) before the Maintenance phase or the introduction of low-dose 6-Thioguanin (6TG) into the Maintenance phase (TEAM) with monitoring of 6TG-incorporation into the DNA of leukocytes. |
Control (C) |
R1: standard of care (delayed Intensification phase of treatment contains Doxorubicin) R2: standard of care (Delayed Intensification phase contains Doxorubicin and maintenance phase contains Vincristine(VCR)/ Dexamethasone(Dexa) pulses) R3: standard of care |
Outcome (O) |
R1: This is a non-inferiority comparison where we aim to show that removing anthracyclines does not result in an unacceptable reduction in the DFS rate. R2: This is a non-inferiority comparison where we aim to show the removal of anthracyclines in DI OR vincristine and dexamethasone in maintenance do not result in an unacceptable reduction in the DFS rate. R3: The primary endpoint is DFS, where we aim to show an improvement in the 5-year rate from 84% to 90% (i.e. an HR of 0.61). |
Trial Design |
Backbone protocol with 3 randomised questions |
Sample Size |
R1: Over a period of 7 years we expect to be able to recruit 1413 patients to this randomisation (1:1) R2: Over a period of 7 years we expect to be able to recruit 1530 patients to this randomisation (1:1:1) R3: With 1228 patients recruited over 5 years (assuming 39% are Intermediate Risk-High and 80% accept randomisation), an additional 2 years follow-up, a 2-sided 5% alpha we will have 84% power to detect this difference. Belgian participation 510 patients randomised Other participating countries: Sweden, Denmark, Norway, Finland, Iceland, Lithuania, Estonia, UK, Netherlands, Germany, Portugal, Ireland and France. |
Trial duration |
150 months |
Budget |
3.3 Million Euro (incl. VAT) Of which approx. 2.6 Million Euro incl. VAT is BCC and sites costs and 700,000 Euro incl. VAT is diagnostic lab tests. |
Sponsor |
International sponsor: Karolinska University Hospital Belgian Coordinating Centre: UZ GENT |
Chief Investigator |
Sponsor: MD PhD Mats Heyman, Karolinska Institut, Sweden BCC: Dr Veerle Mondelaers, Ghent University Hospital, Belgium |
Trial Coordinator/PM |
Marlies Bekaert, HIRUZ, Ghent University Hospital, Belgium |
External Partners |
Belgian Society for Pediatric Hematology and Oncology (BSPHO) |
Sites |
Departments of pediatric hemato-oncology of 8 different university hospitals across Belgium |
Protocol: | |
Report: Q3/2029 |
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Publication |
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Clinicaltrials.gov: NCT04307576
Eudract number: 2018-001795-38
Investigator-led workstream 2017