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:

• A person must have given documented informed consent (or have a legally authorised representative do so on their behalf).
• A person must be enrolled in the Revlimid REMS program, which is a required safety monitoring program for the drug lenalidomide.
• A person must have a performance status rating of 0–2 on a standard medical scale, meaning they are able to carry out at least some daily activities independently (confirm with trial site).
• A person must have recovered from almost all side effects of previous treatments before joining.
• A person must have a disease that has come back or has stopped responding to previous treatments.
• A person must have already tried and not responded to at least 2 previous systemic (whole-body) treatments. For those with a type of lymphoma affecting lymph nodes called systemic ALCL, one of those treatments must have included a specific drug called brentuximab vedotin.

For people with Cutaneous T-Cell Lymphoma (a type of lymphoma affecting the skin) only:

• A person must have a confirmed diagnosis of mycosis fungoides (MF) or Sézary syndrome (SS), at a specific stage of disease as defined by standard medical staging (confirm with trial site for exact stage requirements).
• A person must have measurable signs of disease based on standard skin assessment tools and/or a specific blood cell count.
• A person must have had a skin biopsy taken within the last 6 months that is available for review by the central study team.

For people with Peripheral T-Cell Lymphoma (a type of lymphoma affecting tissues throughout the body) only:

• A person must have a confirmed diagnosis of peripheral T-cell lymphoma according to standard medical criteria.
• A person must have disease that can be measured or assessed using standard imaging criteria.
• A person must have a sufficiently high white blood cell count (specifically neutrophils) to be considered safe to treat.
• A person must have a sufficiently high platelet count (cells that help blood clot).
• A person must have liver function test results within acceptable ranges.
• A person must have kidneys that are working well enough, as measured by a standard calculation.
• A person must have blood clotting levels within an acceptable range, or within the intended treatment range if already taking blood-thinning medication.
• A person who could become pregnant must have a negative pregnancy test before joining.
• A person who could become pregnant must agree to use two reliable methods of contraception, or to abstain from heterosexual activity, throughout the study and for 90 days after the last dose.
• A male participant must agree to use a reliable method of contraception from the first dose through to 90 days after the last dose.

Who may not be able to join:

• People who have recently received certain types of immunotherapy, including immune checkpoint inhibitors, cell-based therapies, or cancer vaccines.
• People who have previously taken lenalidomide, thalidomide, or similar immunomodulatory drugs.
• People who have received a monoclonal antibody treatment too recently before the trial start date (within a specific time window based on that drug's half-life).
• People who have received any systemic (whole-body) treatment within 28 days, or within 5 half-lives of that treatment (whichever is shorter), before the trial begins.
• People who have received any skin-directed treatment within 14 days before the trial begins.
• People who have received radiation therapy within 21 days before the trial begins.
• People who have taken immune-suppressing medications within 14 days before the first dose, with some exceptions such as low-dose steroids taken at stable doses, or inhaled, nasal, or topical steroids.
• People who have received a live vaccine within 30 days before the trial begins.
• People with a history of non-infectious lung inflammation (pneumonitis) that required steroid treatment, or who currently have pneumonitis.
• People who have had another cancer within the past 5 years, with some exceptions such as certain treated skin cancers, cervical carcinoma in situ, early-stage treated prostate cancer, or other cancers that have been fully treated with surgery or localised radiation.
• People who have had an allergic reaction to thalidomide or to any ingredient in the study drug durvalumab.
• People who are pregnant or breastfeeding.
• People who have previously had a stem cell transplant.
• People who currently have an active infection requiring treatment.
• People with a known history of HIV infection.
• People with an active hepatitis B or C infection.
• People who have ongoing conditions that require long-term steroid or immune-suppressing treatment.
• People with moderate-to-severe nerve damage in their hands or feet (peripheral neuropathy grade 2 or above).
• People who require dialysis due to kidney failure.
• People with unstable heart conditions, including a heart attack in the last 6 months, moderate-to-severe heart failure, or uncontrolled irregular heartbeat or high blood pressure.
• People who have had major surgery within 28 days before the first dose.
• People with an active or recently treated autoimmune or inflammatory condition within the past 3 years, with some exceptions such as vitiligo, stable thyroid conditions managed with hormone replacement, or psoriasis not requiring systemic treatment.
• People with a history of a primary immune system deficiency.
• People with a digestive condition that could significantly affect how the body absorbs the study drug lenalidomide.
• People with any other condition that the trial doctor believes would make participation unsafe or difficult to complete.
• People who, in the opinion of the trial doctor, may not be able to follow all study procedures.

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