A Treatment Study Protocol for Participants 0-45 Years With Acute Lymphoblastic Leukaemia
ConditionLeukemia, Acute Lymphoblastic
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age0-45
SponsorMats Heyman
About this trial
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 criteria
Qualifiers
Patients newly diagnosed with T-lymphoblastic (T-cell) or B-lymphoblastic precursor (BCP) leukaemia (ALL) according to the WHO-classification of Tumours of Haematopoetic and Lymphoid Tissues (Revised 4th edition 2017) and with a diagnosis confirmed by an accredited laboratory at a participating paediatric oncology or adult haematology centre.
Age 0 - < 46 years (one day before 46th birthday) at the time of diagnosis with the exception of infants with KMT2A-rearranged (KMT2A-r) BCP ALL.
Patients with surface immunoglobulin negative (sIG-) BCP-ALL and an IG::MYC rearrangement, unless they have a concurrent BCL2/6 rearrangement. T-ALL patients with MYC translocations.
Informed consent signed by the patient and/or parents/legal guardians according to country-specific age-related guidelines.
Disqualifiers
Age < 365 days and KMT2A-rearranged (KMT2A-r) BCP-ALL (documented presence of a KMT2A-split by FISH and/or a KMT2A fusion transcript).
Age >45 years at diagnosis.
Patients with a previous malignant diagnosis (ALL as a second malignant neoplasm - SMN).
Relapse of ALL.
Trial design
Treatments tested in this trial
- Omitted Doxorubicin
- Omitted Vincristine+Dexamethasone pulses
- Inotuzumab Ozogamicin+Standard Maintenance Therapy
- Imatinib
- 6-tioguanine+Standard Maintenance Therapy
- Blinatumomab
Treatment groups
6,430 Participants
are divided into 10 treatment groups10
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Mats Heyman
Lead sponsor
Karolinska University Hospital
Sponsor institution
The Swedish Research Council
Collaborator
The Swedish Childhood Cancer Foundation
Collaborator
Pfizer
Collaborator
Servier
Collaborator
NordForsk
Collaborator
Aamu Pediatric Cancer Foundation
Collaborator
German Society for Pediatric Oncology and Hematology GPOH gGmbH
Collaborator
Clinical Trial Center North (CTC North GmbH & Co. KG)
Collaborator
Belgium Health Care Knowledge Centre
Collaborator
Karolinska Institutet
Collaborator
Cancer Research UK
Collaborator
Fundação Rui Osório de Castro
Collaborator
Acreditar - Associação de Pais e Amigos das Crianças com Cancro
Collaborator
Grupo Português De Leucemias Pediátricas
Collaborator
Amgen
Collaborator
Nova Laboratories Limited
Collaborator
Danish Child Cancer Foundation
Collaborator
Danish Cancer Society
Collaborator
The Novo Nordic Foundation
Collaborator
Assistance Publique - Hôpitaux de Paris
Collaborator
Direction Générale de l'Offre de Soins
Collaborator
Swedish Cancer Society
Collaborator
Source ClinicalTrials.gov