Phase 3 Leukaemia Trial, Recruiting NCT04307576 Sponsor: Mats Heyman Condition: Leukaemia
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Phase 3 Leukaemia Trial, Recruiting

NCT04307576
Recruiting Phase 3

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:

  • You have been newly diagnosed with a type of blood cancer called acute lymphoblastic leukaemia (ALL) — either T-cell ALL or B-cell precursor ALL — confirmed by an approved laboratory.
  • You are between 0 and 45 years old at the time of diagnosis (with a specific exception for very young infants with a particular genetic change — confirm with trial site).
  • Your leukaemia has specific genetic features: certain patients with a gene change called IG::MYC (without certain other gene changes), or T-ALL patients with a MYC gene change (confirm with trial site for your specific situation).
  • You (and/or your parents or legal guardians, if you are a child) have signed a consent form agreeing to take part.
  • You are being diagnosed and treated at a hospital that is taking part in this trial.
  • You live permanently in one of the countries taking part in the trial, or you plan to stay there (for example, if you are applying for asylum).
  • If you are a woman who could become pregnant, you must have a negative pregnancy test within 2 weeks before starting treatment.
  • There may be additional requirements depending on which specific part of the trial you are being considered for (confirm with trial site).

Who may not be able to join:

  • Babies under 1 year old who have a specific genetic change called KMT2A-rearrangement in their leukaemia.
  • Anyone aged 46 or older at the time of diagnosis.
  • Anyone who has previously had another cancer diagnosis.
  • Anyone whose ALL has already come back (relapsed).
  • Patients with a specific type called "mature B-ALL," or those with certain combined gene changes (IG::MYC together with BCL2/6 rearrangement).
  • Patients whose leukaemia has a gene change called Philadelphia chromosome (Ph-positive ALL) — these patients may be directed to a different, more suitable trial.
  • People who were already known to have certain inherited conditions that increase the risk of ALL (such as Li-Fraumeni syndrome or germline ETV6 mutation) — though Down syndrome is an exception and does not exclude you.
  • Anyone who received steroid medicines above a certain dose for more than one week, or any chemotherapy, in the four weeks before diagnosis.
  • Anyone who has a pre-existing health condition that would prevent them from safely receiving the treatments used in this trial.
  • Anyone with another illness or condition that the doctor believes would make it unsafe or impractical to take part.
  • 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 but unwilling to use effective contraception during treatment.
  • Women who are currently breastfeeding.
  • Cases where important information needed at the time of registration is missing (confirm with trial site).
  • There may be additional reasons specific to certain parts of the trial that could affect eligibility (confirm with trial site).

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 9 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Mats Heyman, MD, PhD, Karolinska University Hospital

Phone: +46 8 123 700 00

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
Phase 3
Sponsor
Mats Heyman
Registry
ClinicalTrials.gov
Start date
13 July 2020
Est. completion
1 June 2033

Where this trial is recruiting

🇧🇪 Belgium 🇩🇰 Denmark 🇪🇪 Estonia 🇫🇮 Finland 🇫🇷 France 🇩🇪 Germany Iceland 🇮🇪 Ireland 🇱🇹 Lithuania 🇳🇱 Netherlands 🇳🇴 Norway 🇵🇹 Portugal 🇪🇸 Spain 🇸🇪 Sweden 🇬🇧 United Kingdom

Primary endpoints

Event-free survival (EFS) for the whole protocol; Event-free survival (EFS) for the TKI intervention; Disease-free survival (DFS) R1 + R2; Disease-free survival (DFS) R3; MRD response after 1 cycle of Blinatumomab

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: 9 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