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:

• People aged 18 or older at the time of joining
• People who have given written consent to take part in the study
• People who have been diagnosed with a specific type of lymphoma called Angioimmunoblastic T-cell Lymphoma (AITL), confirmed by tissue testing at the enrolling hospital, and whose cancer has a specific gene change called an IDH2 mutation
• People whose AITL has come back or stopped responding to at least one previous cancer treatment (for the relapsed/refractory group), and whose tumour sample contains at least 5% tumour cells
• People who stopped previous cancer treatments at least 2 weeks or 5 half-lives (whichever is longer) before starting this trial (confirm with trial site for specific situations)
• People whose general health and ability to carry out daily activities meets a standard medical scoring threshold (ECOG score of 2 or less)
• People whose blood counts and organ function meet minimum levels set by the trial, including white blood cell counts, platelet counts, kidney function, and liver function (confirm with trial site for exact values)
• People whose lymphoma can be measured or detected through standard imaging or blood/bone marrow testing
• Women who could become pregnant must have a negative pregnancy test before joining, and must agree to use effective contraception throughout the trial and for 30 days after the last dose
• Women must agree not to breastfeed during the trial
• Men must agree to use effective contraception or practise complete abstinence during the trial and for 4 months after the last dose, and must avoid causing a pregnancy during this time
• People who are willing and able to attend scheduled visits and follow the trial requirements

Who may not be able to join:

• People with a serious medical condition, abnormal lab results, or a mental health condition that would prevent them from giving informed consent
• People currently taking immunosuppressive medication after a stem cell transplant, or who have significant graft-versus-host disease (GVHD) (certain stable steroid uses may be discussed with the trial team)
• People who still have significant side effects (grade above 1) from previous treatments, other than hair loss or nerve-related symptoms
• People who are pregnant
• People with a history of chronic liver disease, a liver condition called veno-occlusive disease, or alcohol misuse
• People who have received a live vaccine within 6 weeks before the first dose of the trial drug
• People who have had surgery or have a digestive condition that may affect how the body absorbs medication (such as gastric bypass or stomach removal)
• People with HIV who have a detectable viral load, a low CD4 count (below 200), or who are not taking anti-HIV medications
• People with active chronic hepatitis B or C, depending on specific blood test results (confirm with trial site, as some cases may still be eligible with additional precautions)
• People with an active cytomegalovirus (CMV) infection that is causing symptoms and requires treatment
• People currently receiving treatment for another cancer (other than T-cell lymphoma), with some exceptions that may be discussed with the trial team (such as early-stage skin cancers or certain preventive treatments)
• People whose AITL has spread to the brain or the membranes surrounding the brain or spinal cord
• People with an active, uncontrolled infection (fungal, bacterial, or viral) that is not improving with appropriate treatment
• People who have had significant heart problems within the 6 months before starting the trial, including severe heart failure, a heart attack, a stroke, or poor heart pumping function on a recent heart scan
• People who have previously been treated with the drug enasidenib
• People taking certain medications that interact with the trial drug in ways that could be unsafe, including warfarin, phenytoin, thioridazine, theophylline, tizanidine, or S-mephenytoin, unless those medications can be safely switched to alternatives beforehand (confirm with trial site)
• People taking rosuvastatin, unless they are able to safely switch to an alternative medication before starting the trial
• People taking certain other medications (including ezetimibe, raloxifene, or raltegravir) may need dose adjustments or to switch medications before joining (confirm with trial site and relevant prescribing doctor)

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