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:

• You have been diagnosed with a specific type of lymphoma called extranodal NK/T-cell lymphoma, nasal type, confirmed by a tissue test (according to 2022 medical guidelines).
• You have never received any treatment for this lymphoma before.
• You are 18 years of age or older.
• Your doctors expect you to live for more than 3 months.
• Your lymphoma is at an early stage (Stage I or II, meaning it has not spread widely through the body).
• You have at least one area of disease that can be measured or assessed, confirmed by a biopsy before treatment starts.
• You are generally able to carry out daily activities, with only mild limitations at most (based on a standard medical scale scored 0–2).
• You are willing and able to follow the study plan and attend required visits.
• You have signed a form confirming you agree to take part.
• Your bone marrow, liver, and kidneys are working well enough, based on blood tests showing: sufficient white blood cells, platelets, and red blood cells; liver enzyme levels not too far above normal; bilirubin levels within an acceptable range (people with a condition called Gilbert's syndrome may still qualify); and kidneys filtering well enough.
• You can provide a tumor tissue sample (a fresh sample is preferred, but a stored sample may be acceptable).
• If you are a woman who could become pregnant, you agree to use reliable birth control throughout the study.
• If you are a man, you agree to either avoid sexual activity or use a barrier method of contraception (such as a condom) during the study.

Who may not be able to join:

• Your lymphoma is at an advanced stage (Stage III or IV).
• Your NK/T-cell lymphoma is not the nasal type.
• You have had an autoimmune disease (where the immune system attacks the body) in the last 2 years that required treatment with medications such as steroids or immune-suppressing drugs — examples include lupus, rheumatoid arthritis, multiple sclerosis, or inflammatory bowel disease. Note: having a thyroid condition or type 1 diabetes that is being managed with stable medication is generally still allowed, as is standard hormone replacement therapy.
• You have had another type of cancer (other than this lymphoma) within the last 3 years that was not fully treated with the goal of cure, or you are currently receiving cancer treatment for another condition.
• You have a history of lung inflammation (not caused by infection) that needed steroid treatment, or you currently show signs of lung disease of this kind.
• You have an active infection that requires treatment, including: a known history of active tuberculosis; a positive test for hepatitis B surface antigen, hepatitis C, or HIV (hepatitis B may be allowed only if the virus level in the blood is very low); or an active viral infection such as shingles (herpes zoster).
• You have had a serious heart problem in the last 3 months, such as a heart attack, unstable irregular heartbeat, or unstable chest pain.
• You have previously been treated with a type of cancer immunotherapy called anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs.
• You have received a live vaccine within 4 weeks before starting the study, or you would need one during the study (including certain flu vaccines).
• You have taken immune-suppressing medications within 2 weeks before starting the study, or you would need to take them during the study (examples include methotrexate, azathioprine, or thalidomide).
• The lymphoma has spread to your brain or spinal cord (central nervous system).
• You have previously had an organ or tissue transplant from another person.
• You have had a severe allergic reaction to PD-1 antibody medicines or to a drug called gorlitinib, or to any of their ingredients.
• The study doctor believes there are other reasons that might make it difficult for you to safely follow the study plan (confirm with trial site).

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