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NCT07354074

NCT07354074
Recruiting Phase 2 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • You must be willing and able to sign a consent form before joining the study (for children, a parent or guardian will do this)
  • You must be aged 1 year old up to (but not including) 18 years old when you enroll
  • You must have been diagnosed with a specific type of leukemia called CML in chronic phase (an early, more stable stage), confirmed by a specific lab test showing a chromosome change called the Philadelphia chromosome
  • You were either newly diagnosed with this condition within the last 3 months, OR your current or previous leukemia medication (called a TKI) is not working well enough or is causing serious side effects — this includes situations where lab results show the leukemia is not responding as expected at certain checkpoints (3, 6, or 12 months), or where the leukemia has started becoming resistant to treatment
  • A specific lab test done at screening must detect a particular form of the leukemia gene (BCR::ABL1) that can be accurately measured with a standard test
  • You must be well enough to carry out some daily activities, measured by a standard health score (confirm with trial site)

Who may not be able to join:

  • You have returned to the early/stable phase of CML after it had previously progressed to a more advanced stage
  • You have already had a stem cell transplant (a procedure using donor blood stem cells)
  • You are currently planned to have a stem cell transplant
  • Lab tests show your leukemia has a specific genetic change that is already known to make it resistant to the medication being studied in this trial

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.

Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Novartis Pharmaceuticals
Registry
clinicaltrials_gov
Start date
28 April 2026
Est. completion
23 February 2033

Where this trial is recruiting

🇦🇺 Australia 🇨🇦 Canada 🇰🇷 South Korea

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

Primary endpoints

MMR at Week 48

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: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov