KCE-17010: Eine klinische Studie für Kinder und junge Erwachsene mit akuter lymphoblastischer Leukämie (ALL) - ALLTogether-Studie1

Zusammenfassung (Niederländisch oder Französisch oder Englisch)

Trial Description
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.

Status

Open

 

Trial team

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
Dokumente
Protocol:  
Report: Q3/2029

 

Publication

 

REFERENZEN

Clinicaltrials.gov: NCT04307576

Eudract number: 2018-001795-38

Finanzierungssystem

Investigator-led workstream 2017