Phase 2 Leukaemia Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been diagnosed with certain blood cancers or solid tumours confirmed by laboratory testing, including chronic myeloid leukaemia (CML), acute lymphoblastic leukaemia (ALL), acute myeloid leukaemia (AML), other leukaemias, lymphoma, brain tumours, or other solid tumours where standard treatment is no longer available or suitable.
• People with chronic-phase CML (in Phase 2, Group A) whose cancer has stopped responding to, or who could not tolerate, at least one prior targeted therapy for CML, or who have a specific genetic change called the T315I mutation, or who have a "warning" response to prior treatment.
• People with chronic-phase CML (Phase 2, Group A) who have had a bone marrow test confirming the BCR-ABL genetic change, performed within 42 days before starting the study drug.
• People with leukaemia or solid tumours (in Phase 2, Group B) whose cancer has specific genetic mutations such as RET, FLT3, KIT, FGFR, PDGFR, TIE2, VEGFR, or others where the study drug may have an effect, confirmed on tumour tissue.
• People with solid tumours or lymphoma whose disease can be measured on a CT or MRI scan according to standard measurement guidelines.
• People with CML (in Phase 1) whose cancer has stopped responding to, or who could not tolerate, at least one prior targeted therapy for CML.
• People with ALL (in Phase 1 or Phase 2, Group B) whose cancer has continued to grow after all available treatments, including at least one prior targeted CML therapy where applicable.
• People with AML or other leukaemias whose cancer progressed after at least one prior treatment attempt (required in France) or for whom no effective standard treatment is available (other countries).
• People with solid tumours or lymphomas whose cancer progressed despite standard therapy, or for whom no effective standard therapy is available or suitable.
• People aged 16 and over with a functional ability score of at least 40% on the Karnofsky scale, or children under 16 with a Lansky Play Scale score of at least 40% (confirm with trial site).
• People who have recovered from most side effects of previous treatments to a mild or baseline level (hair loss is an exception and does not need to have resolved).
• People who are willing to take steps to avoid pregnancy or fathering children during the trial.

Who may not be able to join:

• People with BP-CML, ALL, or AML who have received corticosteroids or hydroxyurea within 24 hours, vincristine within 7 days, or most other chemotherapy within 14 days before starting the study drug.
• People with other cancer types who have received standard chemotherapy within 21 days (or 42 days for certain specific drugs) before starting the study drug.
• People who have had radiation therapy or radioactive treatment within 6 weeks before starting the study drug (except limited local radiation for symptom relief given within 14 days).
• People who have had a stem cell transplant within 3 months before starting the study drug.
• People who have had major surgery within 14 days before starting the study drug, or who have not fully recovered from major surgery.
• People who have taken immune-suppressing medications (including post-transplant regimens) within 14 days before starting the study drug.
• People who have taken any targeted cancer therapy, including other TKIs, within 7 days before starting the study drug.
• People who have taken any other experimental cancer treatment within 30 days, or within 5 half-lives of that drug (whichever is longer), before starting the study.
• People who have received monoclonal antibody cancer therapy within 5 half-lives before starting the study drug (confirm with trial site for specific timeframe).
• People who have received CAR-T cell therapy within 28 days before starting the study drug.
• People who have previously been treated with ponatinib (the study drug).
• People with current signs, imaging results, or blood tests indicating pancreatitis.
• People with certain heart conditions, including a weakened heart pump function below specified levels on heart scans, an abnormal heart rhythm measurement (QTcF of 450 ms or more) on an ECG, unstable chest pain, a heart attack within the past 6 months, severe heart failure (New York Heart Association Class III or IV), or an uncontrolled irregular heartbeat requiring treatment.
• People with uncontrolled high blood pressure.
• People currently taking medications known to cause dangerous heart rhythm changes (QTc prolongation or TdP), unless those medications can be safely switched or stopped.
• People with solid tumours that have spread to the brain, or people with active leukaemia affecting the central nervous system (brain and spinal cord).
• People with a significant pre-existing brain condition, including a history of severe brain injury, dementia, certain brain diseases, psychosis, movement disorders, or autoimmune disease affecting the brain.
• People with a history of stroke or brain bleeding who still have lasting neurological effects (those whose neurological symptoms have fully resolved may still be considered — confirm with trial site).
• People with seizures that are not well controlled.
• People with a significant bleeding disorder or blood-clotting condition unrelated to their cancer.
• People with gut conditions that could prevent the study drug from being properly absorbed, such as malabsorption syndrome.
• People with certain inherited genetic conditions including Fanconi anaemia, Bloom syndrome, or Down syndrome.
• People with active graft-versus-host disease rated Grade 2 or above.
• People with an active, uncontrolled infection currently requiring antibiotic, antifungal, or antiviral treatment.
• People with active hepatitis B or hepatitis C infection requiring treatment, or people at risk of hepatitis B reactivation (based on specific blood test results).
• People with a known HIV infection.
• People who are currently taking medications that are not permitted during this trial (confirm with trial site for the specific list).
• People with a known serious allergy or sensitivity to ponatinib or any of its ingredients.
• People who have recently received or who are expected to need live vaccines during the study.
• People who, in the opinion of the trial doctor, are unlikely to be able to follow the dosing schedule and study requirements.
• People who are currently pregnant or breastfeeding.
• Additional exclusion criteria may apply (confirm with trial site).

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