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Clinical Trials in Spain / NCT03911128
Recruiting Observational

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

NCT03911128 · tracked via the Priya Life Science Spain tracker
Sponsor
Mats Heyman
Phase
Observational
Started
2019-08-29
Last updated
2026-08-13

Condition(s) studied

Leukemia, Acute Lymphoblastic

Investigational drug(s) / intervention(s)

Observational

Observational: Observational study - no intervention

Study summary

The pilot study 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 platform 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 trials included in the study-design.

The pilot study is implemented as a master protocol without study specific interventions, thus as an observational study. The pilot study is for countries/study-groups who intend to join ALLTogether1 (including experimental interventions). For these countries the pilot study is crucial to optimise diagnostics, registration systems, collaborations with vendors, logistics and data-checks before starting the main study.

The study only includes "standard of care" treatment included in the master protocol.

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 Haematopoietic 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-r BCP ALL (see exclusion criteria below). * 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 and patients who intend to stay at least for the duration of the treatment 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. 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). These patients will be transferred to an appropriate trial for infant KMT2A-r BCP-ALL, if available. * 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::ABL1 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, see section 18.9. * Female patients, who are breast-feeding. * Essential data missing from the registration of characteristics at diagnosis (in consultation with the protocol chair).

Primary outcome measure(s)

Trial sites (57)

FacilityCityRegionStatus
Aalborg University Hospital, Dept of Paediatrics Aalborg Denmark Active Not Recruiting
Aarhus University Hospital Aarhus Denmark Active Not Recruiting
Aarhus University Hospital, Child and Adolescent Health Aarhus Denmark Active Not Recruiting
Rigshospitalet, Dept of Haematology Copenhagen Denmark Active Not Recruiting
Rigshospitalet, Dept of Paediatrics Copenhagen Denmark Active Not Recruiting
Odense University Hospital, Dept of Paediatrics Odense Denmark Active Not Recruiting
North Estonia Medical Centre, Dept of Haematology Tallinn Estonia Not Yet Recruiting
Tallinn Children´s Hospital, Dept of Paediatrics Tallinn Estonia Not Yet Recruiting
Tartu University Hospital Tartu Estonia Not Yet Recruiting
Helsinki University Hospital, Dept of Haematology Helsinki Finland Active Not Recruiting
Helsinki University Hospital, Dept of Paediatrics Helsinki Finland Active Not Recruiting
Kuopio University Hospital, Dept of Haematology Kuopio Finland Active Not Recruiting
Kuopio University Hospital, Dept of Paediatrics Kuopio Finland Active Not Recruiting
Oulu University Hospital, Dept of Haematology, Dept of Medicine Oulu Finland Not Yet Recruiting
Oulu University Hospital, Dept of Paediatrics Oulu Finland Active Not Recruiting
Tampere University Hospital, Dept of Haematology Tampere Finland Not Yet Recruiting
Tampere University Hospital, Dept of Paediatrics Tampere Finland Active Not Recruiting
Turku University Hospital, Clinical Haematology and Stem Cell Transplantation Unit Turku Finland Not Yet Recruiting
Turku University Hospital, Dept of Paediatrics Turku Finland Active Not Recruiting
Landspitali University Hospital, Children's Hospital Reykjavik Iceland Active Not Recruiting
Children's Hospital, Affiliate of Vilnius University Hospital Vilnius Lithuania Active Not Recruiting
Vilnius University Hospital Vilnius Lithuania Active Not Recruiting
Haukeland University Hospital, Dept of Haematology Bergen Norway Active Not Recruiting
Haukeland University Hospital, Dept of Paediatrics Bergen Norway Active Not Recruiting
Oslo University Hospital, Dept of Haematology Oslo Norway Active Not Recruiting
Oslo University Hospital, Dept of paediatric haemato- and oncology Oslo Norway Active Not Recruiting
Stavanger University Hospital, Dept of Haematology Stavanger Norway Active Not Recruiting
University Hospital North Norway, Dept of Haematology Tromsø Norway Active Not Recruiting
University Hospital of North Norway, Dept of Paediatrics Tromsø Norway Active Not Recruiting
St. Olavs University Hospital, Dept of Paediatrics Trondheim Norway Active Not Recruiting
St. Olavs University Hospital, Dept of Haematology Trondheim Norway Active Not Recruiting
Hospital Universitario Dr.Balmis Alicante Spain Recruiting
Hospital Universitario de Cruces Barakaldo Spain Recruiting
Hospital Universitario San Joan de Déu Barcelona Spain Active Not Recruiting
Hospital Universitario Vall d'Hebron Barcelona Spain Active Not Recruiting
Hospital Universitario La Paz Fuencarral-El Pardo Spain Recruiting
Hospital Infantil Universitario Nino Jesus Madrid Spain Recruiting
Hospital Clínico Universitario Virgen de la Arrixaca Murcia Spain Recruiting
Hospital Universitario Son Espases Palma de Mallorca Spain Recruiting
Hospital Universitario Marqués de Valdecilla Santander Spain Recruiting

+ 17 more sites — see the full list on the official registry below.

More Mats Heyman trials in Spain

Other trials for the same condition

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 NCT03911128 on ClinicalTrials.gov ↗ ← All trials in Spain