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 at the time of giving consent.
• People who have signed a consent form agreeing to take part and allowing their personal health information to be used for the study.
• People who are reasonably active and able to care for themselves, as measured by a standard health performance scale (score of 0 or 1), assessed within 7 days before starting treatment.
• People who have been diagnosed with a specific type of skin lymphoma called Mycosis Fungoides or Sézary Syndrome, confirmed by a tissue test, at an advanced stage (Stage IIB to IVB).
• People who have measurable signs of the disease that can be tracked using a standard assessment tool, checked within 30 days before treatment starts.
• People who have areas of disease that have not been treated with radiation, even if other areas were previously radiated (as long as that radiation was more than 7 days before starting treatment).
• People who have already tried at least one systemic (whole-body) treatment for their condition that did not work, with that prior treatment completed at least 28 days before starting this trial and with any side effects largely resolved.
• People who can provide stored tissue samples (10–15 unstained slides from within 90 days of joining the study), or who are willing to have a skin biopsy if no stored samples are available.
• People whose use of steroid medications is below a certain low dose (less than the equivalent of 10 mg per day of prednisone), or who use only inhaled, nasal, or topical steroids. Certain exceptions for adrenal replacement therapy and short steroid courses also apply (confirm with trial site).
• People whose blood, kidney, liver, and clotting test results fall within the ranges required by the trial, tested within 28 days before starting treatment.
• People who have a negative pregnancy test (blood test) within 72 hours before joining, if there is any chance of pregnancy.
• People who are willing to either avoid heterosexual intercourse or use an effective method of contraception throughout the trial, as outlined in the study protocol (applies to both males and females).
• People who have cancer that has spread to the brain or spinal fluid, provided all other criteria are also met.
• People who are expected to live for at least 6 months.
• People who, in the opinion of the enrolling doctor, are able to understand and follow the study procedures for the full duration of the trial.

Who may not be able to join:

• People with a known history of HIV infection.
• People with both active Hepatitis B and active Hepatitis C infections at the same time.
• People who have previously been treated with certain immune checkpoint therapies, specifically pembrolizumab or mogamulizumab.
• People who have received radiation therapy to their disease within 7 days before starting treatment.
• People who have a condition that weakens the immune system, or who are currently taking high-dose steroid medications (more than the equivalent of 10 mg per day of prednisone) or other immune-suppressing medications within 7 days before starting treatment.
• People who have an active or past autoimmune or inflammatory condition that required systemic treatment within the last 2 years — with exceptions for conditions like vitiligo or hair loss, and for standard hormone or gland replacement therapies.
• People who have a history of, or currently have, a non-infectious lung condition (pneumonitis or interstitial lung disease) that required steroid treatment.
• People who have another cancer that is currently growing or has needed active treatment within the past 2 years (certain minor skin cancers and non-spreading in-place cancers that do not require systemic treatment may still be eligible — confirm with trial site).
• People who currently have an active infection that requires systemic (whole-body) treatment.
• People who have previously received a bone marrow or stem cell transplant from another person, or certain cell-based therapies from another person.
• People who have previously received a solid organ transplant (such as a kidney or liver transplant).
• People who are currently pregnant or breastfeeding.
• People who have had a severe allergic reaction (Grade 3 or higher) to pembrolizumab, mogamulizumab, or any of their ingredients.
• People who have taken part in another clinical trial using an experimental drug or device within 30 days before joining.
• People who have received a live or live-weakened vaccine within 30 days before the first dose of the study treatment (non-live vaccines, including mRNA or inactivated COVID-19 vaccines, are permitted).
• People with known serious psychiatric conditions or substance use problems that would make it difficult to follow the study requirements.
• People who, in the treating doctor's opinion, have any condition, history, or circumstance that could interfere with the study results or make participation not in their best interest.

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