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 have been diagnosed with ALK-positive anaplastic large cell lymphoma (ALK+ ALCL), confirmed by standard laboratory testing as recognised under current diagnostic guidelines.
• People whose lymphoma has come back or stopped responding to treatment after at least one previous course of treatment, which must have included at least one standard chemotherapy drug.
• People who were receiving an ALK-blocking drug (ALK inhibitor) right before joining, including those whose cancer is currently in remission on that drug — as long as an immediate stem cell transplant is not being planned.
• People who previously took an ALK inhibitor, provided they did not stop it and stay in remission for six months or more without any other treatment in between (confirm with trial site if unsure).
• People aged 18 or older at the time of joining.
• People who are generally well enough to carry out basic daily activities, as measured by a standard health scale used by doctors (ECOG score of 0, 1, or 2).
• People whose blood counts, kidney function, and liver function meet specific thresholds set by the trial (the trial site will check these before treatment starts).
• People who are able to swallow tablets or capsules.
• People who are able to take a preventive medication against a specific type of lung infection (called PJP).
• Women who could become pregnant must have a negative pregnancy test within 14 days before starting treatment.
• Women of childbearing age must use effective contraception during treatment and for 5 weeks after the last dose of the study drugs.
• Men must use effective contraception during treatment and for 3 months after the last dose of the study drugs.

Who may not be able to join:

• People who received a stem cell transplant from a donor within the past 6 months, or people who currently have active graft-versus-host disease (a complication from a previous transplant) — though exceptions may be possible after discussion with the trial's lead doctor.
• People who received other systemic cancer treatment for their lymphoma within 7 days before starting the study drug (some exceptions may apply, such as for radiation therapy or steroid use, after discussion with the trial site).
• People currently taking immune-suppressing medications, including steroid doses higher than 10 mg per day of prednisone or an equivalent drug.
• People with a prior stomach or bowel condition or surgery that a doctor believes could interfere with how the body absorbs the study drugs.
• People with an active hepatitis B or hepatitis C infection (people with past exposure but no active virus detected by blood testing may still be eligible — confirm with trial site).
• People living with HIV may be able to join, but only if they have been on an approved HIV treatment regimen for at least 12 weeks before starting the trial, and are not taking certain specific HIV medications that interact with the study drugs (confirm details with trial site).
• People who have another cancer that required active treatment within the past 2 years, with some exceptions for certain limited or low-risk cancers (confirm with trial site).
• People with an active CMV (cytomegalovirus) infection that is causing symptoms and requiring treatment.
• People currently taking medications that are strong blockers or activators of a liver enzyme called CYP450 3A, which can affect how the study drugs work.
• Women who are pregnant or breastfeeding.
• People with a serious unstable medical condition, significant laboratory abnormality, or mental health condition that, in the treating doctor's judgement, would make participation unsafe or prevent them from giving informed consent.

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