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 who have been diagnosed with a type of blood cancer called T-cell Non-Hodgkin lymphoma (T-NHL), confirmed through a tissue biopsy.
• People who are willing and able to give written consent to take part (or have a legal representative do so on their behalf).
• People who are generally well enough to carry out light activity and care for themselves — meaning they are not confined to bed for more than half of their waking hours (this is measured using a standard scale called ECOG, and a score of 0 or 1 is required).
• People with one of these specific types of T-NHL: Peripheral T-cell lymphoma not otherwise specified (PTCL-NOS), Angioimmunoblastic T-cell lymphoma (AITL), Anaplastic large-cell lymphoma (ALCL), Natural killer/T-cell lymphoma (nodal or extranodal), Cutaneous T-cell lymphoma (including mycosis fungoides or Sézary syndrome), Transformed T-cell lymphoma, Enteropathy-associated T-cell lymphoma (EATL), Subcutaneous panniculitis-like T-cell lymphoma (SCPTCL), or Hepatosplenic T-cell lymphoma.
• People whose cancer cells test positive for a protein called CD30 (more than 1%) on a previous biopsy sample.
• People whose lymphoma has come back or stopped responding to at least one prior treatment — previous treatment with a drug called Brentuximab is allowed, provided it was not stopped due to serious side effects (grade 2 or higher) and was not completely ineffective.
• People with peripheral T-cell lymphoma (PTCL) who have at least one measurable area of disease that is 1.5 cm or larger.
• Women who are not pregnant and not breastfeeding — those who could become pregnant must have a negative pregnancy test within 72 hours before the first dose, and must agree to use an acceptable method of contraception from the time of signing consent and for at least 4 months after the last dose of pembrolizumab.
• Men who agree to use contraception during treatment and for at least 4 months after the last dose of pembrolizumab, and who agree not to donate sperm during this time.
• People whose organ function and blood counts are within acceptable levels, tested within 10 days before the first dose (confirm specific values with trial site).

Who may not be able to join:

• People who have previously been treated with certain immune checkpoint drugs that work on the PD-1, PD-L1, or PD-L2 pathways, or similar drugs that affect how the immune system is activated or controlled (such as those targeting CTLA-4, OX-40, or CD137).
• People diagnosed with adult T-cell leukemia/lymphoma (ATLL).
• People who have received any anti-cancer treatment, including experimental therapies, within 4 weeks before the first dose — though a shorter gap may be considered for certain drugs (confirm with trial site). People must have recovered from side effects of previous treatments before joining. Certain ongoing skin treatments for cutaneous T-cell lymphoma may be allowed (confirm with trial site).
• Women who are pregnant or breastfeeding, or who have a positive pregnancy test at screening.
• People who have had radiotherapy within 2 weeks before starting the study, or who have not fully recovered from radiation side effects — a shorter 1-week gap may be allowed for limited palliative radiation to non-brain areas (confirm with trial site).
• People who have a history of lung inflammation (pneumonitis) or scarring of the lungs (interstitial lung disease) that required steroid treatment, or who currently have these conditions.
• People who have received a live or live-attenuated vaccine within 30 days before the first dose — inactivated (killed) vaccines are allowed.
• People who are currently in, or who have recently participated in, another clinical trial involving an experimental drug or device within 4 weeks before the first dose.
• People who have been diagnosed with a condition that weakens the immune system, or who are taking high-dose steroid tablets (more than the equivalent of 10 mg of prednisone per day) or other immune-suppressing medications within 7 days before the first dose.
• People who have an autoimmune disease that required systemic medical treatment in the past year — some conditions managed only with hormone replacement or affecting only the skin without systemic treatment may still be eligible (confirm with trial site).
• People who have an active, uncontrolled infection that requires antibiotic or antifungal treatment — people must be fever-free for at least 48 hours without antibiotics before starting (unless the fever is caused by the lymphoma itself).
• People with active inflammation of the heart muscle (myocarditis), or severe heart failure (classified as NYHA class III or IV).
• People with active cancer that has spread to the brain or the lining around the brain — people with previously treated and stable brain involvement may be eligible if they meet specific stability requirements (confirm with trial site).
• People who have had another cancer within the past year — some exceptions may apply for certain early-stage skin cancers or cervical or breast carcinoma in situ (confirm with trial site for other cancer histories).
• People with a known severe allergic reaction (grade 3 or higher) to the study drug pembrolizumab or any of its ingredients.
• People with a known history of HIV infection.
• People with a known history of active Hepatitis B or Hepatitis C infection.
• People with any other medical condition, treatment history, or laboratory result that the treating doctor believes would interfere with the study or would not be in the person's best interest.
• People with a clinically significant history of liver disease, including current alcohol-related liver disease or cirrhosis.
• People with known psychiatric conditions or substance use disorders that would make it difficult to take part in the trial.
• People with a known history of active tuberculosis (TB).
• People who have had an allogeneic stem cell transplant (a transplant using donor cells) within the last 5 years, or who have active graft-versus-host disease (GVHD).
• People with moderate to severe nerve damage (peripheral neuropathy grade 2 or higher).

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