Phase 2 Leukaemia Trial, Recruiting

Written by an AI model from the 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 relapsed or treatment-resistant acute myeloid leukaemia (AML), acute lymphoblastic leukaemia (ALL), or a related type of acute leukaemia, and whose disease has continued to grow after standard treatments have been tried.
• At certain trial locations, people with a bone marrow condition called myelodysplastic syndrome (MDS) — where at least 5% of bone marrow cells are abnormal blast cells — who have tried at least 2 cycles of a standard medication class called hypomethylating agents (HMAs) and whose disease has not responded or has come back.
• At certain trial locations, people with multiple myeloma (MM) whose disease has come back or stopped responding after at least 3 different treatment regimens, including specific drug types called a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody.
• People whose cancer has a specific genetic change known as a KMT2A (MLL) fusion or an NPM1 mutation — this requirement applies in some countries as required by local health authorities (confirm with trial site).
• People who have been offered a stem cell transplant as an option (applies to those who may be eligible for one).
• For the Phase 2 part of the trial: people with relapsed AML or ALL where at least 5% of bone marrow cells are blast cells, confirmed by a tissue review, and who have not previously been treated with a type of drug called a menin inhibitor.
• People aged 18 years or older. At some locations, young people aged 12 and over who weigh at least 40 kg may be eligible for one type of treatment in this trial (confirm with trial site).
• People who are reasonably active and able to care for themselves, as measured by a standard medical scale called the ECOG performance status of 2 or below (this means someone who may not be able to do heavy physical work but can look after themselves).
• People whose kidneys are functioning at an adequate level, as measured by a standard blood test.
• People whose liver function results (bilirubin, AST, and ALT levels) fall within the acceptable ranges set by the trial.
• People whose side effects from any previous cancer treatments have mostly resolved, apart from mild hair loss or mild nerve-related symptoms.
• People who are able and willing to attend all required visits during the study.
• People with an estimated life expectancy of at least 3 months, based on the treating doctor's assessment.
• Women who could become pregnant must have a negative pregnancy blood test before joining.
• All participants who could father or carry a child must agree to use a highly effective form of contraception throughout the study and for 6 months after the last dose of the study drug.
• People who can provide bone marrow or blood samples suitable for genetic testing of their cancer.

Who may not be able to join:

• People whose heart is not pumping efficiently enough, specifically where the heart's pumping function (left ventricular ejection fraction) is below 50% on a heart scan.
• People diagnosed with a specific type of leukaemia called acute promyelocytic leukaemia.
• People who have taken certain immune-suppressing medications called calcineurin inhibitors within 2 to 4 weeks before starting the study drug (confirm exact timeframe with trial site).
• People whose heart electrical activity test (ECG) shows certain abnormal results at the time of screening, or who have a personal history of a heart rhythm problem called prolonged QT syndrome, or who need to take medications known to affect the heart's electrical rhythm.
• People who have an active bacterial, viral, or fungal infection that requires treatment through a drip (intravenous therapy) and is not under control.
• People currently taking certain medications that strongly interact with a liver enzyme called CYP3A4/5, including specific antifungal drugs such as ketoconazole, isavuconazole, and itraconazole (some other antifungals may be permitted — confirm with trial site).
• People who have had major surgery within 28 days before starting the study drug.
• People whose leukaemia has spread to the brain or spinal fluid and is currently active.
• People who have received a bone marrow/stem cell transplant (HSCT) or a specialised immune cell therapy (CAR-T or similar) within 60 days before starting the study drug (or within 6 months for sites in the UK — confirm with trial site).
• People who have received a donor lymphocyte infusion within 28 days before starting the study drug, or who are still on immune-suppressing treatment after a transplant, or who have active graft-versus-host disease (a complication of transplants) requiring medical treatment.
• People who have received cancer-treating drugs or other experimental treatments within 7 days or 5 half-lives (whichever is shorter) before starting the study drug — with some exceptions such as hydroxyurea.
• People with serious ongoing health conditions such as severe heart failure, unstable chest pain, certain heart rhythm problems requiring treatment, a recent heart attack within 6 months, serious breathing difficulties at rest or with minimal activity, uncontrolled high blood pressure, or diabetes with more than 2 episodes of a serious complication called ketoacidosis in the past 6 months.
• People with a detectable level of HIV or hepatitis C in their blood, or evidence of active hepatitis B infection.
• People who have difficulty swallowing, absorbing food through the gut, or other conditions that would prevent them from taking oral (swallowed) medication.
• People whose mental health, psychological state, or ability to understand information would make it unsafe or impractical for them to participate in the trial or to give informed consent.
• People who are pregnant, breastfeeding, or planning to become pregnant during the study period. People who are breastfeeding may be considered if they stop breastfeeding before the first dose and do not resume for at least 6 months after the last dose (confirm with trial site).
• People in Japan (Phase 1 dose escalation) with any history of a lung condition called interstitial lung disease. For sites in the European Union, people with a history of a moderate or severe drug-related lung inflammation within the past 6 months.
• People with a history of a serious heart rhythm problem called Torsades de Pointes.
• People with multiple myeloma who also have a high level of abnormal plasma cells circulating in the blood (a condition called plasma cell leukaemia).
• People entering the gilteritinib combination group who have previously received a type of drug called a FLT3 inhibitor for relapsed or treatment-resistant disease (prior use in initial treatment is allowed — confirm with trial site).
• People with a known severe allergic reaction to any ingredient in the study drug.
• For trial sites in the UK only: people entering a specific combination treatment group who have received a live vaccine within 30 days before starting the study drug.

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