Phase 3 Leukaemia Trial, Recruiting NCT06852222 Sponsor: Janssen Research & Development, LLC Condition: Leukaemia
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Phase 3 Leukaemia Trial, Recruiting

NCT06852222
Recruiting Phase 3 🇦🇺 Australian site

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 who are 18 years of age or older at the time of signing the consent form
  • People who have been diagnosed with a specific type of acute myeloid leukemia (a blood cancer) that has not yet been treated, involving particular gene changes (called KMT2Ar or NPM1m), with at least 10% abnormal cells found in the bone marrow
  • People who have been assessed by their doctor as not suitable for intensive (strong) chemotherapy — this applies to people aged 75 or older based on their doctor's judgment, or people aged 18 to under 75 who have at least one serious health condition such as reduced physical ability, a severe heart condition, a severe lung condition, kidney problems, moderate liver problems, or another condition the treating doctor considers makes intensive chemotherapy unsuitable (confirm with trial site for full details on how this is assessed)
  • People whose liver and kidney are functioning at an adequate level as determined by the trial team
  • Female participants who agree not to be pregnant or breastfeed, not to plan a pregnancy, and to use specific birth control methods during the trial and for 6 months after the last dose of study treatment
  • Male participants who agree to use specific birth control methods during the trial and for at least 90 days after the last dose of study treatment
  • People who have read and signed a consent form showing they understand and are willing to take part in the study

Who may not be able to join:

  • People diagnosed with a specific subtype of blood cancer called acute promyelocytic leukemia (APL)
  • People with active leukemia that has spread to the brain or spinal cord
  • People who have previously received a solid organ transplant (such as a kidney, liver, or heart transplant)
  • People who have experienced certain heart-related events within the 6 months before joining, including a heart attack, uncontrolled chest pain, heart failure, uncontrolled or symptomatic irregular heartbeat, a blocked blood vessel to the brain, or a mini-stroke
  • People with a currently active hepatitis infection affecting the liver
  • People who have received a live vaccine within 4 weeks before joining the trial
  • People with known allergies or sensitivities to the study medications (bleximenib, azacitidine, or venetoclax) or their ingredients

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
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: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Phone: 844-434-4210

Australian sites

Flinders Medical Centre, Bedford Park,
Royal Prince Alfred Hospital, Camperdown,
St Vincents Hospital Melbourne, Fitzroy,
St George Hospital, Kogarah,
Peter MacCallum Cancer Centre, Melbourne,
Princess Alexandra Hospital, Woolloongabba,

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
Registry
ClinicalTrials.gov
Start date
4 June 2025
Est. completion
22 June 2029

Where this trial is recruiting

🇦🇺 Australia 🇦🇹 Austria 🇧🇪 Belgium 🇧🇷 Brazil 🇨🇦 Canada 🇨🇳 China 🇨🇿 Czechia 🇩🇰 Denmark 🇫🇷 France 🇩🇪 Germany 🇬🇷 Greece Hong Kong 🇭🇺 Hungary 🇮🇱 Israel 🇮🇹 Italy 🇯🇵 Japan 🇲🇽 Mexico 🇵🇱 Poland 🇵🇹 Portugal 🇰🇷 South Korea 🇪🇸 Spain 🇹🇼 Taiwan Turkey (Türkiye) 🇬🇧 United Kingdom 🇺🇸 United States

6 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Percentage of Participants who Achieve Complete Remission (CR); Overall Survival (OS)

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