Phase 2 Leukaemia Trial, Recruiting
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:
- Children and teenagers aged 1 to under 18 years old (for the pediatric medicine group), or teenagers aged 14 to under 18 and weighing at least 40 kg (for the adult medicine group).
- People diagnosed with a specific type of chronic leukemia called Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP), with certain blood and bone marrow test results falling within required ranges at the screening visit.
- People who have previously been treated with at least one type of targeted leukemia medicine called a TKI (tyrosine kinase inhibitor).
- People whose most recent TKI treatment either stopped working or caused side effects they could not tolerate.
- People with a physical fitness and functioning level at or above a certain threshold, measured using age-appropriate scales (Karnofsky scale for those 16 and older, Lansky scale for those under 16).
- People with kidneys, liver, pancreas, and heart functioning adequately at the time of screening.
- People with blood electrolyte (mineral) levels within normal ranges, or levels that can be brought into normal range with supplements before starting the study medicine.
- People whose leukemia shows a specific genetic marker (BCR::ABL1 transcript type e14a2 and/or e13a2) that can be measured with a standard lab test.
Who may not be able to join:
- People known to have a specific genetic mutation called T315I, or any other mutation known to be resistant to the study medicine, before joining the trial.
- People who are in a second chronic phase of their leukemia after having previously progressed to a more advanced stage.
- People who have previously had a stem cell (bone marrow) transplant.
- People who are planning to have a stem cell transplant from a donor.
- People with certain heart rhythm or heart electrical abnormalities.
- People with serious or uncontrolled other medical conditions that the trial doctor believes could create unacceptable risks or make it difficult to follow the trial requirements.
- People who have had acute pancreatitis (sudden pancreas inflammation) within the past year, or who have a history of long-term pancreas problems.
- People with a history of acute or chronic liver disease.
- People with stomach or digestive system conditions that could significantly affect how the study medicine is absorbed by the body.
- People who are pregnant or currently breastfeeding.
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.
Contact this trial
Principal Investigator: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Phone: 1-888-669-6682
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
Where this trial is recruiting
Primary endpoints
Primary Pharmacokinetic (PK) parameter: AUClast; Primary PK parameter: AUCtau; Secondary PK parameter: Cmax; Secondary PK parameter: Tmax; Secondary PK parameter: Ctrough
Can't join this trial?
Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.