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

ConditionLeukemia, Acute Lymphoblastic

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age0-45

SponsorMats Heyman

About this trial

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 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 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

Disqualifiers

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.