Phase 3 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 at the time of signing the consent form
• People with a confirmed diagnosis of certain types of T-cell lymphoma (PTCL-NOS, FHTCL, or sALCL), confirmed by tissue testing, as classified under the International Consensus Classification
• People whose cancer has come back, stopped responding to treatment, or who could not tolerate standard treatment, and who have received at least 1 but no more than 3 prior systemic (whole-body) cancer treatments
• People whose cancer shows up on a PET scan and has at least one measurable tumour of 1.5 cm or larger on a CT scan
• People with a general health/activity level rated as 0, 1, or 2 on a standard oncology scale (meaning able to carry out at least some daily activities) (confirm with trial site)
• People with a life expectancy of more than 12 weeks
• People whose blood counts, kidney, liver, and other organ functions meet specific minimum levels as assessed by blood tests (confirm with trial site for exact values)
• People who have recovered from most side effects of previous treatments to a mild level or back to their normal baseline before joining (some exceptions apply, such as mild nerve-related symptoms)
• Women of childbearing potential who agree to use at least one highly effective form of contraception from screening until 120 days after the last dose of one study drug, or 6 months after the last dose of the other study drugs
• Men who are not surgically sterilised and are sexually active with a female partner who could become pregnant must agree to use a condom and spermicide from the first dose until 120 days after the last dose

Who may not be able to join:

• People whose T-cell lymphoma has spread to or is actively affecting the brain or spinal cord
• People with a significant medical condition, abnormal lab results, or a psychiatric illness that could prevent safe participation
• People with a history of a primary immune system disorder or who have had a solid organ transplant (such as a kidney or liver transplant)
• People who have had a serious opportunistic infection within the 30 days before screening that still requires active treatment
• People who currently have an active infection requiring intravenous (IV) antibiotics or antifungals
• People who have had another invasive cancer requiring systemic treatment within the last 3 years
• People known to be HIV positive, or who test positive for active hepatitis B or hepatitis C infection
• People who have received certain cancer treatments recently — including monoclonal antibody therapy, chemotherapy, or radiation within 3 weeks, or targeted therapy within 2 weeks before starting the study drug
• People who have previously been treated with a type of drug called an ITK inhibitor (confirm with trial site)
• People who need urgent, immediate treatment to reduce their cancer burden quickly
• People who are currently taking certain medications that strongly affect how the body processes drugs (known as strong CYP3A inhibitors or inducers), or who have taken them recently (confirm with trial site)
• People who have previously had an allogeneic stem cell transplant (a transplant using donor cells)
• People who are considered candidates for a stem cell transplant at the time of screening
• People whose cancer progressed within 6 months of an autologous stem cell transplant (a transplant using their own cells)
• People who are currently enrolled in another clinical trial
• Women who are pregnant, breastfeeding, or planning to become pregnant during the study period and up to 6 months after the last dose
• People who are unable to swallow tablets or capsules, or who have a condition that prevents proper absorption of oral medications

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