A Treatment Study Protocol for Participants 0-45 Years With Acute Lymphoblastic Leukaemia
Condition(s) studied
Investigational drug(s) / intervention(s)
Omitted Doxorubicin: Omission of IV Doxorubicin
Omitted Vincristine+Dexamethasone pulses: Omission of Vincristine+Dexamethasone pulses
Inotuzumab Ozogamicin+Standard Maintenance Therapy: Addition of IV Inotuzumab ozogamicin before Maintenance Therapy
Imatinib: p.o. Imatinib
6-tioguanine+Standard Maintenance Therapy: Addition of p.o. 6-tioguanine to Standard Maintenance Therapy
Blinatumomab: IV Blinatumomab
Study summary
ALLTogether collects the experience of previously successful treatment of infants, children and young adults, with ALL from a number of well-renowned study groups into a new master protocol, which is both a comprehensive system for stratification and treatment of ALL in this age-group as well as the basis for several randomised and interventional trials included in the study-design.
Eligibility
Primary outcome measure(s)
- Event-free survival (EFS) for the whole protocol — 5 year estimates from the time of diagnosis will be measured but adequate follow-up for these estimates will be ensured: at least 5 years follow-up.
The primary endpoint for the whole protocol (compared with the legacy protocols of the participating study-groups forming the consortium) is event-free survival (EFS) - as defined in the protocol. - Event-free survival (EFS) for the TKI intervention — From the start of TKI (day 15 or day 30), 5 year estimates will be measured but adequate follow-up for these estimates will be ensured: at least 5 years follow-up for all interventions except Inotuzumab-randomisation (minimum 2-year follow-up).
The primary endpoint for the TKI intervention is event-free survival (EFS) - as defined in the protocol, from the start of TKI until event or end of follow-up - Disease-free survival (DFS) R1 + R2 — 5 and 8 year estimates from the time of randomisation will be measured but adequate follow-up for these estimates will be ensured: at least 5 years follow-up.
The primary endpoint for Randomisation 1 and 2 is disease-free survival (DFS) - as defined in the protocol counting from the time of randomisation - Disease-free survival (DFS) R3 — 5 year estimates from the time of randomisation will be measured but adequate follow-up for these estimates will be ensured: at least 2-year follow-up
The primary endpoint for Randomisation 3 and the ABL-class fusion intervention is disease-free survival (DFS) - as defined in the protocol counting from the time of randomisation (R3) and the start of TKI-therapy (ABL-class fusion intervention). - MRD response after 1 cycle of Blinatumomab — End of first Blinatumomab infusion +/- 1 week
Fraction of patients with undetectable MRD ("Complete MRD response") at the end of one cycle of Blinatumomab (+/- 1 week)
Trial sites (137)
| Facility | City | Region | Status |
|---|---|---|---|
| L'hôpital Universitaire des enfants Reine Fabiola (Huderf) | Brussels | Belgium | Recruiting |
| Cliniques Universitaires Saint-Luc (UCL) | Brussels | Belgium | Recruiting |
| University Hospital Antwerp | Edegem | Belgium | Recruiting |
| University Hospital Ghent | Ghent | Belgium | Recruiting |
| University Hospital Leuven, Dept of Paediatrics | Leuven | Belgium | Recruiting |
| CHC MontLégia, Boulevard Patience et Beaujonc 2 | Liège | Belgium | Recruiting |
| CHR de la Citadelle | Liège | Belgium | Recruiting |
| Aalborg University Hospital, Dept of Paediatrics | Aalborg | Denmark | Recruiting |
| Aarhus University Hospital | Aarhus | Denmark | Recruiting |
| Aarhus University Hospital, Child and Adolescent Health | Aarhus | Denmark | Recruiting |
| Rigshospitalet, Dept of Haematology | Copenhagen | Denmark | Recruiting |
| Rigshospitalet, Dept of Paediatrics | Copenhagen | Denmark | Recruiting |
| Odense University Hospital, Dept of Paediatrics | Odense | Denmark | Recruiting |
| North Estonia Medical Centre, Dept of Haematology | Tallinn | Estonia | Recruiting |
| Tallinn Children´s Hospital, Dept of Paediatrics | Tallinn | Estonia | Recruiting |
| Tartu University Hospital | Tartu | Estonia | Recruiting |
| Helsinki University Hospital, Dept of Haematology | Helsinki | Finland | Recruiting |
| Helsinki University Hospital, Dept of Paediatrics | Helsinki | Finland | Recruiting |
| Kuopio University Hospital, Dept of Haematology | Kuopio | Finland | Recruiting |
| Kuopio University Hospital, Dept of Paediatrics | Kuopio | Finland | Recruiting |
| Oulu University Hospital, Dept of Haematology, Dept of Medicine | Oulu | Finland | Recruiting |
| Oulu University Hospital, Dept of Paediatrics | Oulu | Finland | Recruiting |
| Tampere University Hospital, Dept of Haematology | Tampere | Finland | Recruiting |
| Tampere University Hospital, Dept of Paediatrics | Tampere | Finland | Recruiting |
| Turku University Hospital, Clinical Haematology and Stem Cell Transplantation Unit | Turku | Finland | Recruiting |
| Turku University Hospital, Dept of Paediatrics | Turku | Finland | Recruiting |
| CHU Amiens Groupe Hospitalier Sud | Amiens | France | Recruiting |
| CHU Angers | Angers | France | Recruiting |
| CHRU Besançon | Besançon | France | Recruiting |
| CHU Bordeaux - Groupe Hospitalier Pellegrin | Bordeaux | France | Recruiting |
| CHRU Brest - Morvan | Brest | France | Recruiting |
| Centre Hospitalier Universitaire Caen | Caen | France | Recruiting |
| CHU Clermont-Ferrand | Clermont-Ferrand | France | Recruiting |
| CHU Dijon Hôpital François Mitterrand | Dijon | France | Recruiting |
| CHU de Grenoble site Nord - Hôpital Albert Michallon | Grenoble | France | Recruiting |
| CHRU de Lille - Hôpital Jeanne de Flandre | Lille | France | Recruiting |
| Hôpital de la mère et de l'enfant | Limoges | France | Recruiting |
| CHU de Lyon HCL - GH Est-Institut d'hématologie et d'oncologie pédiatrique IHOP | Lyon | France | Recruiting |
| CHU de Marseille - Hôpital de la Timone | Marseille | France | Recruiting |
| CHU de Montpellier - Hôpital Arnaud de Villeneuve | Montpellier | France | Recruiting |
+ 97 more sites — see the full list on the official registry below.
On this site
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Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04307576 on ClinicalTrials.gov ↗ ← All trials in Sweden