Trial Details

Trial status:

Active (recruiting)

Recruitment start date:

18/05/2021

Funder:

Cancer Research UK

Sponsor:

Chief Investigator:

Mats Marshall Heyman (Karolinska Institute); John Moppett (UK Lead)

Recruitment target:

3000

EudraCT number:

2018-001795-38

Contact details:

ctc.alltogether@ucl.ac.uk

ALLTogether-1

ALLTogether1– A Treatment study protocol of the ALLTogether Consortium for children and young adults (0-45 years of age) with newly diagnosed acute lymphoblastic leukaemia (ALL)

Description

Design:

The treatment protocol collects the experience of previously successful treatment of children and young adults, with acute lymphoblastic leukaemia (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.

Treatment:

The main treatment for ALL is chemotherapy, depending on the patient enrolled there are a number of drugs given in different combinations. Chemotherapy usually works well for children and young adults with ALL. But we know from research that it is important to look at the risk of the leukaemia coming back after treatment (relapse) and plan treatment based on this risk. This means giving less treatment to people with a low risk of their leukaemia coming back. And giving more treatment to people with a higher risk of the leukaemia coming back.

The trial use several factors to find out patients risk groups which determines the treatment they receive, these include:

- gene changes inside the leukaemia cells

- how quickly leukaemia went away with chemotherapy

Key inclusion/exclusion criteria: Inclusion:

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 -
Informed consent signed by parents/guardians and/or the patient according to country-specific age related guidelines (https://www.ema.europa.eu/en/documents/other/informed-consent-paediatric-clinical-trials-europe-2015_en.pdf) before any study-specific activity is performed.
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. However, some treatment, supportive care and follow-up, as well as registration, may be delegated to a shared care centre under the supervision of a study centre.
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 sexually active women of childbearing potential (WOCBP) have to have a negative pregnancy test within 2 weeks prior to the start of treatment.

Exclusion:

Age
Age >45 years at diagnosis (from the 46th birthday onwards)
Patients with a previous malignant diagnosis (ALL as a second malignant neoplasm - SMN). However, patients with a history of skin cancer (except melanoma) with only local treatment are eligible.
Relapse of ALL.
Patients with mature B-ALL (as defined by Surface Ig positivity or documented presence of one of the t(8;14)(q24;q32), t(2;8)(p12;q24), t(8;22)(q24;q11) translocations involving the MYC gene and breakpoints as in mature B-NHL/ALL).
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 apropriate trial for t(9;22) if available.
ALL prone syndromes (e.g. Li-Fraumeni syndrome, germline ETV6 mutation), except for Down syndrome. Exploration for such ALL prone syndromes is not mandatory.
Treatment with systemic corticosteroids (>10mg/m2/day) for more than one week and/or any chemotherapeutic agents during the 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 treatment according to the protocol).
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.

Duration of recruitment: Recruitment started in 2021, and will continue until at least May 2027.

Aim

The primary objective of ALLTogether is to improve survival and quality of survival in children and young adults with acute lymphoblastic leukaemia (ALL) by a number of interventions that will be tested in a randomised fashion, compared with well-defined control-populations within the protocol or explored in a non-randomised fashion to obtain baseline information regarding characteristics, leukaemia-specific outcomes and toxicity. A sub-group of patients will be identified that may benefit from novel immunotherapy.

Contact the trial team

View trial documents

Cancer Research UK & UCL Cancer Trials Centre
University College London
90 Tottenham Court Road
London
W1T 4TJ

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Email:
ctc.enquiries@ucl.ac.uk
Telephone:
+44 (0)20 7679 9898 (General CTC Enquiries)
Fax:
020 7679 9899

CTC staff

University College London, Gower Street, London, WC1E 6BT +44 (0)20 7679 2000