Leukaemia Trial, Recruiting NCT03911128 Sponsor: Mats Heyman Condition: Leukaemia
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Leukaemia Trial, Recruiting

NCT03911128
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People newly diagnosed with T-cell or B-cell precursor acute lymphoblastic leukaemia (ALL), confirmed by an approved laboratory at a participating cancer or blood disease centre.
  • People who are between 0 and 45 years old (up to the day before their 46th birthday) at the time of diagnosis — with an exception for very young infants with a specific genetic type of ALL (see below).
  • People with a specific type of B-cell precursor ALL that tests negative for surface immunoglobulin and has a particular gene change called IG::MYC, unless a second gene change (BCL2/6) is also present — or T-cell ALL patients with a MYC gene change.
  • People who are diagnosed and treated at a centre that is officially participating in this trial.
  • People who live permanently in one of the countries participating in the trial, or who intend to stay — for example, people applying for asylum. People visiting as tourists are not included, though returning long-term residents or people planning to stay for the full treatment may be considered if no treatment has yet been given and tests are repeated at a participating centre.
  • People (or their parents or legal guardians) who have signed the required consent forms, following the rules of their country.
  • Women who could become pregnant must have a negative pregnancy test within 2 weeks before treatment starts.

Who may not be able to join:

  • Infants under 365 days old who have a specific genetic type of ALL involving the KMT2A gene — these patients may be directed to a different trial designed for this group.
  • People who are 46 years old or older at the time of diagnosis.
  • People who have previously had a cancer diagnosis before this ALL diagnosis.
  • People whose ALL has come back after earlier treatment (relapse).
  • People with a type called mature B-ALL (which tests positive for surface immunoglobulin), or those with the IG::MYC gene change alongside a BCL2/6 gene change.
  • People with a type of ALL involving a specific chromosome change known as Philadelphia chromosome positive (Ph+) ALL — these patients may be directed to a different, more appropriate trial.
  • People already known to have certain inherited conditions that make ALL more likely (such as Li-Fraumeni syndrome or a germline ETV6 mutation) — though Down syndrome is an exception and does not exclude someone. Note: testing for these conditions is not required to join, and patients in whom a new inherited change is discovered during the study may remain in the trial.
  • People who received steroid medicines (above a specific dose) for more than one week, or any chemotherapy, in the four weeks before diagnosis.
  • People who have a pre-existing health condition that would prevent them from safely receiving the treatments used in this trial (confirm with trial site).
  • People with any other condition that the treating doctor believes would make it unsafe or unsuitable for them to participate in the study.
  • Women who are pregnant at the time of diagnosis.
  • Women who could become pregnant, or men who could father a child, who are sexually active and are not willing to use reliable contraception throughout treatment.
  • Women who are currently breastfeeding.
  • Cases where important information required at the time of diagnosis registration is missing (this is determined in discussion with the trial leadership).

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 12 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Mats Heyman, M.D. PhD, Karolinska University Hospital

Phone: +46812370000

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Mats Heyman
Registry
ClinicalTrials.gov
Start date
29 August 2019
Est. completion
1 June 2033

Where this trial is recruiting

🇩🇰 Denmark 🇪🇪 Estonia 🇫🇮 Finland Iceland 🇱🇹 Lithuania 🇳🇴 Norway 🇪🇸 Spain 🇸🇪 Sweden

Primary endpoints

Event-free survival (EFS) compared to historical controls; Overall survival (OS) compared to historical controls

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 12 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov