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 who are willing and able to sign a dated consent form before any study procedures begin.
• People who can provide a tissue sample (either stored or newly collected) from their lymphoma for central laboratory review to confirm the diagnosis.
• People who are 18 years of age or older.
• People who are reasonably active and able to care for themselves, with no significant decline in their general wellbeing in the past two weeks (confirm with trial site for specific activity scale used).
• People with a life expectancy of at least 12 weeks, as assessed by their doctor.
• People who have been confirmed by specialist pathology review to have one of the following specific subtypes of peripheral T-cell lymphoma (PTCL): PTCL not otherwise specified (NOS), Angioimmunoblastic T-cell lymphoma (AITL), Follicular T-cell lymphoma, or PTCL with a TFH (T follicular helper) cell pattern.
• People whose lymphoma can be measured on scans, meaning the affected lymph nodes or other disease sites are large enough to track over time (confirm with trial site for specific size thresholds).
• People who have never previously received any systemic drug treatment for their T-cell lymphoma.
• People whose blood counts and organ function (bone marrow, liver, kidneys, and heart) meet minimum levels required for safe participation (confirm with trial site for specific values).
• People whose heart pumping function is at least 50%, as measured by an echocardiogram or similar heart scan.
• People who are willing and able to follow the study schedule and attend follow-up visits.
• People of childbearing potential (including females from the onset of menstruation up to age 55, unless certain medical conditions apply) who agree to use approved contraception during the study and for 4 months after their last dose of the study drug.
• Males participating in the study who agree to use approved contraception during the study and for 4 months after their last dose, and who agree not to donate sperm for at least 6 months after their last treatment.

Who may not be able to join:

• People who have previously received any investigational cancer drug, cytotoxic chemotherapy, a JAK or STAT3 inhibitor, or immune checkpoint therapy (such as PD-1, PD-L1, or CTLA-4 inhibitors) for their lymphoma.
• People who have taken high-dose corticosteroids (equivalent to more than 40 mg per day of prednisone) within 7 days before starting the study.
• People who have had major surgery or a serious injury within 4 weeks before starting the study, or who are expected to need major surgery during the study.
• People who have received a live vaccine within 28 days before starting the study.
• People currently taking, or unable to stop at least one week before starting the study, certain medications or herbal supplements that strongly affect how the body processes the study drug (confirm with trial site for specific substances).
• People whose lymphoma has spread to the brain or the lining around the brain or spinal cord.
• People with severely reduced lung function, or a history of significant lung inflammation (such as pneumonitis) that required steroid treatment, or currently active lung disease of that type.
• People with conditions that require ongoing treatment with immune-suppressing medications, biologics, or anti-inflammatory drugs (NSAIDs).
• People with active infections, including active tuberculosis, HIV, active hepatitis B or C, active shingles (zoster), or any infection currently requiring antibiotic, antiviral, or antifungal treatment.
• People with significant heart problems, including moderate-to-severe heart failure, serious heart rhythm or electrical problems, a heart attack within the past 6 months, unstable chest pain, a history of heart transplant, or certain abnormalities on a resting heart tracing (ECG) — including a prolonged QTc interval or conditions that increase the risk of dangerous heart rhythms.
• People who have had a blood clot in the lungs or deep veins within the past 90 days (those with a clot more than 6 months ago who have been on appropriate blood-thinning treatment for at least 90 days may still be considered — confirm with trial site).
• People who have had another type of cancer within the past 5 years, with some exceptions such as certain treated skin cancers or early-stage cervical or uterine cancers (confirm with trial site).
• People with ongoing nausea and vomiting that cannot be controlled, significant digestive diseases, an inability to swallow tablets, or previous major bowel surgery that could affect absorption of the study drug.
• People with a known allergy or sensitivity to golidocitinib or to drugs with a similar structure.
• People with severe or poorly controlled health conditions such as uncontrolled high blood pressure or active uncontrolled bleeding, as assessed by the treating doctor.
• People with mental health, personal, social, or geographical circumstances that would make it difficult to follow the study requirements.
• People who are pregnant, as the study drug may harm a developing baby. People who are breastfeeding are also excluded, as the effects on a nursing infant are unknown.

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