🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Contributor sign in
Latest
Clinical Trials in Germany / NCT04307576
Recruiting Phase 3

A Treatment Study Protocol for Participants 0-45 Years With Acute Lymphoblastic Leukaemia

NCT04307576 · tracked via the Priya Life Science Germany tracker
Sponsor
Mats Heyman
Phase
Phase 3
Started
2020-07-13
Last updated
2026-08-12

Condition(s) studied

Leukemia, Acute Lymphoblastic

Investigational drug(s) / intervention(s)

Omitted DoxorubicinOmitted Vincristine+Dexamethasone pulsesInotuzumab Ozogamicin+Standard Maintenance Therapy →Imatinib →6-tioguanine+Standard Maintenance TherapyBlinatumomab →

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

Sex
ALL
Min age
0 Years
Max age
45 Years
Healthy volunteers
No
Inclusion Criteria: * 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. * The ALL diagnosis should be confirmed by an accredited laboratory at a participating paediatric oncology or adult haematology centre. * The patient should be diagnosed and treated at a participating paediatric oncology or adult haematology centre in the participating countries. * The patient should be a resident in one of the participating countries on a permanent basis or should intend to settle in a participating country, for instance by an application for asylum. Patients who are visiting the country as tourists should not be included. However, returning expatriots with primary diagnosis abroad may be included if no treatment has been administered and the diagnostic procedures are repeated at a participating centre. * All women of childbearing potential (WOCBP) have to have a negative pregnancy test within 2 weeks prior to the start of treatment. * For each intervention/randomisation an additional set of inclusion-criteria is provided. Exclusion Criteria: * 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. * Patients with mature B-ALL (as defined by surface IG positivity) or any patients with IG::MYC and a concurrent BCL2/6 rearrangement. * Patients with Ph-positive ALL (documented presence of t(9;22)(q34;q11) and/or of the BCR::ABL fusion transcript). These patients will be transferred to an appropriate trial for t(9;22) if available. * Previously known ALL prone syndromes (e.g. Li-Fraumeni syndrome, germline ETV6 mutation), except for Down syndrome. Exploration for such ALL prone syndromes is not mandatory and patients in whom genetic work-up reveals a new germ-line mutation (index-cases) will remain in the study. * Treatment with systemic corticosteroids corresponding to (\>10mg prednisolone/m2/day) for more than one week and/or other chemotherapeutic agents in a 4-week interval prior to diagnosis (pre-treatment). * Pre-existing contraindications to any treatment according to the ALLTogether protocol (constitutional or acquired disease prior to the diagnosis of ALL preventing adequate treatment). * Any other disease or condition, as determined by the investigator, which could interfere with the participation in the study according to the study protocol, or with the ability of the patients to cooperate and comply with the study procedures. * Women of childbearing potential who are pregnant at the time of diagnosis. * Women of childbearing potential and fertile men who are sexually active and are unwilling to use adequate contraception during therapy. Efficient birth control is required. * Female patients, who are breast-feeding. * Essential data missing from the registration of characteristics at diagnosis (in consultation with the protocol chair). * For each intervention/randomisation an additional set of exclusion-criteria is provided.

Primary outcome measure(s)

Trial sites (137)

FacilityCityRegionStatus
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

📄 Gleevec (imatinib) drug profile →
Official registry record

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 Germany