Phase 2 Lymphoma Trial, Recruiting

Written by an AI model from the 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 have been diagnosed with mycosis fungoides (a type of skin lymphoma) confirmed by biopsy, at any stage from I to IV, including those who have some abnormal Sézary cells in their blood at diagnosis or at enrollment, as long as the count is below 1,000 cells per microlitre and the disease is currently present in the skin.
• People whose mycosis fungoides has come back or stopped responding to treatment, and whose cancer cells test positive for a marker called CD30 on at least 1% of cells.
• People whose previous systemic (whole-body) cancer treatments were stopped at least one week before starting this trial.
• People who had certain chemotherapy that affected blood cell counts, provided those counts have recovered to safe levels (white blood cell count above 1,000 and platelets above 50,000) before starting.
• People using low-dose steroids (equivalent to 10 mg per day of prednisone or less) may be considered if stopping the steroids could cause a disease flare, adrenal problems, or unnecessary discomfort — this would be decided in discussion with the lead trial doctor.
• People aged 18 or older.
• People who are well enough to carry out basic daily activities, as measured by a standard medical scale (ECOG performance score of 3 or below).
• People do not need to wait a specific period after stopping prior treatments before enrolling (confirm with trial site).
• People who are HIV-positive, provided they have been on a stable HIV treatment for at least 12 weeks before starting the trial, and their CD4 immune cell count is above 200 within 7 days before starting.
• People who are able to understand the trial and are willing to sign a written consent form.

Who may not be able to join:

• People who are currently using other systemic (whole-body) cancer treatments or steroids for mycosis fungoides or related conditions (unless steroids are needed for a diagnosed adrenal condition).
• People who have moderate or severe nerve damage or pain (Grade 2 or higher neuropathy).
• People with severely reduced kidney function (kidney clearance rate below 30 mL/min).
• People with moderate or severe liver disease (classified as Child-Pugh B or C).
• Women who could become pregnant and are not abstinent must have a negative pregnancy blood test within one week of starting the trial, and reliable contraception must be in place throughout treatment and for a washout period determined by the treating doctor. Male partners of women who could become pregnant must also use a condom and spermicide during this period. Methods such as rhythm or withdrawal are not considered acceptable. Breastfeeding must also be stopped during this period.
• People currently receiving systemic treatment for a different, unrelated cancer (other than T-cell lymphoma). People with more than one type of lymphoma may be considered after discussion with the lead trial doctor.
• People with serious underlying health conditions, such as unstable heart disease or other significant illnesses, that could make it unsafe to undergo treatment.
• People whose medical history or test results are considered by the lead trial doctor likely to interfere with safe participation.
• People taking certain medications that strongly affect how the body processes a drug called monomethyl auristatin E — specifically, strong CYP3A4 inhibitors or inducers, or P-gp inhibitors (confirm specific medications with trial site).

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