Phase 2 Lymphoma 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:

• Adults aged 18 or older (and for some groups, teenagers aged 12–18 who weigh at least 40 kg) who are willing to give written consent before any screening tests are done
• People with blood cancers (such as AML, CLL/SLL, or certain lymphomas) that have come back or stopped responding to treatment, confirmed by laboratory testing — specific disease subtypes and prior treatment requirements vary by group (confirm with trial site)
• Newly diagnosed AML patients (in certain groups) who have specific genetic changes, certain cell types, or who meet a particular risk scoring system (confirm with trial site)
• AML patients (in one specific group) whose cancer has not responded well enough after 2 cycles of azacitidine and venetoclax treatment
• People whose liver is working well enough, based on blood test results within acceptable ranges
• People whose kidneys are working well enough, based on blood tests or calculations
• People with blood amylase levels within an acceptable range
• People who are reasonably well and able to carry out daily activities, rated 0–2 on a standard performance scale used by oncologists
• People whose blood salt levels and uric acid have been stable for at least 3 days before starting the study drug
• People who have recovered from most side effects of previous cancer treatments (minor ongoing issues such as hair loss, mild tiredness, or mild nerve symptoms may still be acceptable)
• Women who could become pregnant and men with partners who could become pregnant, who agree to use highly effective contraception during treatment and for a set period afterward (90 days or 6 months depending on the group)
• People with AML whose white blood cell count is below 50,000 per microlitre at the time of starting (medication to help lower this count beforehand may be permitted)
• People with a life expectancy of at least 12 weeks (or at least 6 weeks for some groups)
• People with certain blood count levels at screening, within ranges specified for their disease type (confirm with trial site)

Who may not be able to join:

• People with a type of AML called acute promyelocytic leukaemia (APL)
• People with certain types of lymphoma, including Burkitt lymphoma, lymphoblastic lymphoma, cutaneous T-cell lymphoma, or lymphoplasmacytic lymphoma/Waldenström's macroglobulinemia
• People who are currently suitable candidates for a stem cell transplant
• People who have previously taken any other CDK9 inhibitor drug
• People with a known allergy or sensitivity to the study drug or its ingredients
• People with uncontrolled high blood pressure, or a history of hypertensive crisis or hypertensive encephalopathy
• People who have had serious heart problems in the last 6 months, including severe heart failure, a heart pumping function below 50%, certain abnormal heart rhythms, a heart attack, unstable chest pain, heart bypass surgery, or stenting — or who have certain abnormal heart measurements on an ECG or echocardiogram
• People who experienced heart damage as a result of previous cancer treatments such as certain chemotherapy drugs or targeted therapies
• People with active hepatitis B or C infections that are not being properly managed; people with HIV may still be considered if their infection is well controlled and they meet specific criteria (confirm with trial site)
• People taking strong medications that significantly affect how the body processes drugs (strong CYP3A4 inhibitors or inducers) within 7 days before starting; also, certain foods including grapefruit, Seville oranges, pomelos, star citrus, and St. John's wort must be avoided for at least 7 days before starting
• People who have had a stroke or bleeding in the brain within the past 6 months
• People who have had major surgery within the past 4 weeks
• People who are pregnant or breastfeeding
• People who received a donor stem cell transplant within the past 6 months (those who received their own stem cells back must be more than 3 months post-transplant and meet blood count requirements)
• People with another serious uncontrolled illness or condition that, in the doctor's judgement, could put them at risk
• People taking medications known to affect heart rhythm in a particular way (QT prolongation) that cannot be stopped before starting the trial, with some exceptions for certain antifungal medications in AML patients
• People who have received recent cancer treatments such as chemotherapy, targeted therapy, immunotherapy, or CAR-T cell therapy — specific waiting periods apply depending on the treatment type and disease group (confirm with trial site)
• People with very large tumour masses (10 cm or more) requiring shrinkage treatment before entering the trial
• People who have had wide-field radiotherapy within the past 28 days, or targeted palliative radiotherapy within the past 7 days
• People with active or symptomatic cancer spread to the brain or spinal cord (some people with stable, asymptomatic brain involvement may still be considered — confirm with trial site)
• People taking high-dose steroid tablets (more than 20 mg of prednisone or equivalent per day); inhaled or skin-applied steroids are generally acceptable
• People with certain abnormal heart enzyme levels in blood tests at the start of screening
• People with a condition called hypereosinophilic syndrome (very high levels of a particular white blood cell type)
• People who have had a blood clot in the lungs within the past 6 months, or a history of other significant blood clots that the doctor considers a risk
• People who have had another cancer within the past 5 years (or 2 years for AML patients), with some exceptions for certain low-risk, early-stage cancers
• People with a high risk of bleeding in the stomach or gut, including active ulcers or a recent history of vomiting blood or black stools within the past 2 months
• Newly diagnosed AML patients (Group 4) who have certain low-risk genetic markers, as these patients are not eligible for that group (confirm with trial site)
• Newly diagnosed AML patients (Group 4) who have previously received any anti-leukaemia treatment, with very limited exceptions for emergency use of specific medications
• AML patients in Group 5 who have received any anti-leukaemia treatment other than exactly 2 cycles of venetoclax and azacitidine

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