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 are 18 years of age or older at the time of signing the consent form
• People who are able to give written consent to participate and agree to privacy authorization
• People who are willing to follow all study procedures and remain available for the full length of the trial
• People whose general physical functioning falls within a certain range on a standard health scale used by doctors (called the ECOG scale, scores 0–2), meaning they are able to carry out at least some daily activities (confirm with trial site)
• People whose doctor estimates they have a life expectancy of at least 12 weeks
• People who have been diagnosed with one of the following types of lymphoma confirmed by a tissue test: Hodgkin Lymphoma (HL) that has come back or stopped responding after at least one previous treatment; a specific type called Primary Mediastinal Large B-Cell Lymphoma (PMBCL) that did not respond to first-line treatment; or other types of B-cell Non-Hodgkin Lymphoma (including Diffuse Large B-Cell, Follicular, Marginal Zone, or Mantle Cell Lymphoma) that have stopped responding after at least two previous treatments — with some additional conditions depending on the type (confirm with trial site)
• People who have a stored tumour tissue sample available, or who are willing to have a biopsy taken before entering the study if no sample is available
• People whose blood counts, kidney function, and liver function meet certain minimum levels based on blood tests done within 10 days before the first treatment (confirm with trial site for specific values)
• Women of childbearing potential who have a negative pregnancy test within 72 hours before the first dose
• Women of childbearing potential who are willing to use an accepted method of contraception during the study and for 120 days after the last dose (abstinence is accepted if it is their usual choice)
• Men who are capable of fathering children and who agree to use an accepted method of contraception from the first dose through 120 days after the last dose (abstinence is accepted if it is their usual choice)
• People who have previously had CAR-T cell therapy, provided at least 3 months have passed since that treatment ended

Who may not be able to join:

• People who are currently taking part in another clinical trial or who received an experimental treatment or device within the past 4 weeks
• People with cancer that has spread to the brain or the lining of the brain, unless the brain involvement was previously treated, has been stable for at least 4 weeks, and no steroid treatment has been needed for at least 14 days
• People whose physical functioning has declined significantly (to a poor level on the ECOG scale) in the period just before treatment is due to start
• People with a diagnosed immune system disorder, or who have been taking steroid or immune-suppressing medications within the 7 days before the first dose (hormone replacement therapies such as thyroid or insulin are not counted as immune-suppressing)
• People who have a known allergy or sensitivity to pembrolizumab (one of the study drugs) or any of its ingredients
• People who have a known reason they cannot take ATRA (also called tretinoin or all-trans retinoic acid), including past allergic reactions to it or related medications, or who are currently taking certain medications that interact with it (confirm with trial site for the full list)
• People who received a cancer-targeting antibody treatment within 4 weeks before the study start, or who have not yet recovered from side effects of such a treatment
• People who received chemotherapy, targeted drug therapy, or radiation within 2 weeks before the study start, or who have not yet recovered from side effects (some exceptions apply — confirm with trial site)
• People who have been diagnosed with another cancer in the past 5 years, unless it was an early-stage skin cancer or cervical pre-cancer that was fully treated, or another cancer treated by surgery alone or surgery with radiation with no signs of disease for at least 5 years
• People who have had major surgery (not including a simple biopsy) within 4 weeks before the study start, or who have not yet fully recovered from such surgery
• People with a known history of, or current signs of, non-infectious lung inflammation (pneumonitis)
• People with an active, uncontrolled infection (bacterial, viral, or fungal) that requires treatment
• People whose doctor believes participation would not be in their best interest, or whose overall condition might interfere with the trial results
• People with known psychiatric conditions or substance use problems that would make it difficult to follow the study requirements
• People who are pregnant, breastfeeding, or planning to become pregnant or father a child during the study period and up to 120 days after the last dose
• People using a low-dose progesterone-only contraceptive pill ("mini-pill") who are not willing to switch to a different form of contraception
• People who have previously received certain types of immunotherapy drugs that target the PD-1 or PD-L1/PD-L2 pathway
• People with a known history of HIV
• People with known active Hepatitis B or Hepatitis C infection
• People with a known history of active tuberculosis (TB)
• People who have received a live vaccine within 30 days before the planned start of treatment (some flu vaccines are allowed — confirm with trial site)
• People who have received a COVID-19 vaccine or booster within 4 weeks before the first treatment day
• People with a known sensitivity to retinoic acid or related compounds
• People who are taking Vitamin A supplements or certain other medications that affect how the study drug is processed by the body, and who are unwilling to stop taking them before and during the trial
• People who have received a donor (allogeneic) stem cell transplant or a solid organ transplant, unless the transplant occurred more than 5 years ago, in which case the treating doctor may decide on eligibility (people who had their own stem cells transplanted for lymphoma are eligible)

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