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A Treatment Study Protocol for Participants 0-45 Years With Acute Lymphoblastic Leukaemia
EU CTIS ID: 2022-501050-11-01
What this study is testing
The primary objective of ALLTogether is to improve survival and quality of survival in infants, children and young adults with acute lymphoblastic leukaemia 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 either to obtain baseline information regarding characteristics, leukaemia-specific outcomes and toxicity or to be compared with well defined historical controls. A sub-group of patients will be identified that may benefit from novel immunotherapy.
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients newly diagnosed with T-lymphoblastic (T-cell) or B-lymphoblastic precursor (BCP) leukaemia (ALL) according to the WHO-classification of Tumours of Haematopetic 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 days and < 46 years (one day before 46th birthday) at the time of diagnosis.
- Patients with surface IG negative 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 (http://www.ema.europa.eu/docs/en_GB/document_library/Other/2015/12/WC500199234.pdf ).
- 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.
You likely can't join if
- Age < 365 days at diagnosis and KMT2A-r BCP-ALL (documented presence of a KMT2A-split by FISH and/or a KMT2A transcript). These patients will be transferred to an appropriate trial for KMT2A-r BCP infant ALL if available.
- 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).
See the full eligibility criteria
- Patients newly diagnosed with T-lymphoblastic (T-cell) or B-lymphoblastic precursor (BCP) leukaemia (ALL) according to the WHO-classification of Tumours of Haematopetic 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 days and < 46 years (one day before 46th birthday) at the time of diagnosis.
- Patients with surface IG negative 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 (http://www.ema.europa.eu/docs/en_GB/document_library/Other/2015/12/WC500199234.pdf ).
- 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.
- Age < 365 days at diagnosis and KMT2A-r BCP-ALL (documented presence of a KMT2A-split by FISH and/or a KMT2A transcript). These patients will be transferred to an appropriate trial for KMT2A-r BCP infant ALL if available.
- 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).
- For each intervention/randomisation an additional set of exclusion-criteria is provided.
- Age >45 years at diagnosis (from the 46th birthday onwards)
- 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 adequate 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).
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.