Phase 1 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:

• People who are 18 years of age or older.
• People who have been confirmed through a tissue or cell sample to have a specific advanced blood cancer — either acute myeloid leukaemia (AML) that has come back or stopped responding to treatment, or mantle cell lymphoma (MCL) that has come back or stopped responding to treatment after at least two previous treatments (including certain chemotherapy and targeted therapy combinations), with at least one measurable area of disease.
• People whose general physical functioning falls within an acceptable range on a standard medical scale (ECOG score of 0 to 2), meaning they are able to carry out at least some daily activities (confirm with trial site).
• People whose kidneys are working well enough, as shown by a specific kidney function test result.
• People whose liver is working well enough, as shown by certain blood test results being within acceptable ranges.
• People whose heart is pumping blood effectively enough, as measured by a heart scan (at least 50% pumping efficiency).
• People whose side effects from previous treatments have mostly gone away or are very mild.
• Women who could become pregnant must have a negative blood pregnancy test within 7 days before starting the study treatment.
• People who have a negative COVID-19 test result (either a lab-based test or rapid antigen test) shortly before starting the trial.
• People who are willing and able to sign and date a consent form agreeing to take part.

Who may not be able to join:

• Women who are pregnant or breastfeeding.
• Women who could become pregnant, or men whose partners could become pregnant, who are not willing to use two highly effective forms of contraception during treatment and for 120 days after the last dose of the study treatment.
• People who have received cancer treatments such as chemotherapy, radiation, hormonal therapy, or other experimental therapies within the past 14 days or within a certain number of half-lives of the drug (whichever is shorter), or immunotherapy within the past 30 days — though people who have previously received hydroxyurea or dexamethasone may be an exception (confirm with trial site).
• People who have had a bone marrow or stem cell transplant from a donor within the past 60 days.
• People who have taken certain medications known to strongly or moderately affect how the body processes drugs (specific types called CYP3A4 inhibitors or inducers, such as ketoconazole or erythromycin) within a recent period before starting the trial.
• People who have HIV, or hepatitis B or C infections that require antiviral treatment, or who test positive for certain hepatitis markers at levels above set thresholds (confirm with trial site for specific details).
• People who have an active, uncontrolled infection or who currently require isolation.
• People who have had another type of cancer in the past 5 years, with some exceptions such as certain treated skin cancers or early-stage cervical conditions.
• People who still have moderate or severe side effects (grade 2 or higher) from previous treatments, apart from hair loss or hot flashes.
• People whose heart electrical activity shows a specific abnormality (a prolonged QTc interval above 450 milliseconds) on a heart tracing test done during screening.
• People with significant heart problems, including poor heart pumping function below 45%, a history of heart attack or dangerous heart rhythm problems, or who fall into a higher category of heart failure severity (New York Heart Association Class III or above).
• People who have had major surgery within 3 weeks before starting the trial.
• People whose cancer has spread to the brain or the lining around the brain or spinal cord.
• People who have experienced a heart attack, severe chest pain, bypass surgery, stroke, mini-stroke, or seizures within the 6 months before starting the trial.
• People who have had a known allergic or hypersensitivity reaction to any ingredients in the study treatment (PEP07).
• People with other medical or mental health conditions that, in the opinion of the trial doctors, could affect their ability to participate or affect how trial results are interpreted.
• Anyone else the trial doctor determines is not suitable to participate.

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