Phase 1 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 who have been confirmed by biopsy or cell testing to have one of the following types of T-cell lymphoma: mycosis fungoides (MF), Sézary Syndrome (SS), primary cutaneous CD30+ anaplastic large cell lymphoma (cALCL), peripheral T-cell lymphoma not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), or follicular T-cell lymphoma (FTCL).
• People whose lymphoma has come back or stopped responding to at least one previous treatment (such as chemotherapy, radiation, HDAC inhibitors, retinoids, steroids, phototherapy, or other treatments).
• People who have at least one area of measurable disease that can be tracked during the trial.
• People with skin-based (cutaneous) lymphoma at stage IB, II, III, or IV, or people with lymph-node-based (nodal) lymphoma at stages II through IV.
• People who are 18 years of age or older, of any gender.
• People whose last treatment or radiation therapy was at least 4 weeks ago (or 6 weeks if it involved a type of chemotherapy called nitrosoureas), and who have recovered from any side effects of that treatment.
• People with a life expectancy of more than 6 months.
• People with adequate blood counts, liver function, and kidney function as measured by specific laboratory tests (confirm exact thresholds with trial site).
• People with fasting blood triglyceride levels below 300 mg/dL at the time of enrollment.
• Women who could become pregnant must have a negative pregnancy blood test before starting treatment, and must agree to use two forms of birth control throughout the trial and for at least 4 months after the last dose.
• People who are willing and able to give informed consent before any trial procedures begin.

Who may not be able to join:

• People who have had chemotherapy or radiation within the past 4 weeks (or 6 weeks for certain chemotherapy types), or who have not yet recovered from side effects of a previous treatment.
• People who are currently taking part in another clinical trial involving an experimental treatment.
• People who have a known history of cancer that has spread to the brain or central nervous system.
• People who have had an allergic reaction or known sensitivity to retinoids (a class of vitamin A-related compounds) or to any ingredient in ST-001.
• People who currently need to take certain medications that strongly affect how the body processes drugs through a liver enzyme called CYP3A — including specific antifungals, antibiotics, antivirals, herbal supplements such as St John's Wort, and others (confirm the full list with the trial site).
• People who currently need to take medications that moderately or strongly block the CYP3A enzyme — including certain antifungals, some antibiotics, some HIV medications, and others; also people who regularly consume grapefruit or grapefruit juice (confirm full list with trial site).
• People who take vitamin A supplements (standard multivitamins at normal doses are acceptable).
• People with serious uncontrolled illness, such as active infection, severe heart failure, unstable chest pain, irregular heart rhythm, an abnormal heart electrical reading (QTc interval above 450 milliseconds), or mental health or personal circumstances that would make it difficult to follow the trial requirements.
• People who are pregnant or breastfeeding, as ST-001 may harm an unborn or nursing child.
• People who are HIV-positive and currently taking combination antiretroviral therapy, due to potential interactions with ST-001.
• People with an active hepatitis infection.
• People who have night blindness, day blindness, or other eye or retinal conditions such as retinitis pigmentosa or glaucoma at the time of enrollment.
• People who have previously received a treatment called fenretinide.
• People with any type of T-cell lymphoma not listed in the inclusion criteria above, and people with NK-cell or B-cell lymphoma of any type, are not eligible regardless of how or where the disease appears.

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