Health Trials

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

This trial does not accept healthy volunteers

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.

Trial population

Participants 0-45 years with newly diagnosed acute lymphoblastic leukaemia. The protocol has no gender-bias. The total estimated recruitment in the pilot study is 500 participants.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Observational

    Other intervention

    Observational study - no intervention

Treatment groups

500 Participants
are divided into 1 treatment group
Group A: Participants with newly diagnosed ALL1 intervention

Trial outcomes

Primary outcomes

1

Event-free survival (EFS) compared to historical controls

Time frame
5 year
2

Overall survival (OS) compared to historical controls

Time frame
5 year

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mats Heyman

Lead sponsor

Karolinska University Hospital

Sponsor institution

Nordic Society for Pediatric Hematology and Oncology

Collaborator

The Swedish Childhood Cancer Foundation

Collaborator

NordForsk

Collaborator

Source ClinicalTrials.gov
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