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:

General criteria (all participants):

• People who have read, understood, and signed a consent form before any study procedures begin
• People who are 18 years of age or older at the time of signing the consent form
• People who are willing and able to attend scheduled study visits and follow the study requirements
• People who have a confirmed diagnosis of peripheral T-cell lymphoma (a specific type of blood cancer affecting immune cells), based on tissue testing and classified under recognised medical guidelines — tumour tissue from the original diagnosis or a relapse must be available for review (certain subtypes, including mycosis fungoides, Sezary syndrome, lymphoblastic lymphoma, and large granular lymphocytic lymphoma, are excluded)
• People whose lymphoma has come back after treatment or has stopped responding to treatment
• People with a general health score (called ECOG performance status) of 0 to 2, or a score of 3 if that score is believed to be caused by the lymphoma itself
• People whose bone marrow is functioning at an adequate level, including sufficient levels of white blood cells, platelets, and red blood cells (confirm with trial site for specific values)
• People who are expected to live for at least 3 months
• People who have measurable disease that can be tracked during the trial, including at least one area of active disease visible on a specialised scan (FDG-PET scan) and at least one measurable tumour area meeting size requirements (confirm with trial site for specific measurements)
• Women who could become pregnant must have a negative pregnancy test before starting treatment, and must agree not to become pregnant or breastfeed, and to use highly effective contraception during and for a defined period after treatment — they must also not donate eggs during this time
• Men who could father children must agree to use a condom or remain abstinent during and for a defined period after treatment, and must not donate sperm during this time
• People who are covered by a social security system
• People who can understand and speak an official language of the country where the trial is taking place (unless local regulations allow for an independent translator)

Additional criteria for the Origina-ly-T sub-study only:

• People with a type of lymphoma called anaplastic large cell lymphoma who have previously been treated with brentuximab vedotin, were not eligible for it, or could not tolerate it; OR people with extranodal NK/T-cell lymphoma who have previously been treated with an asparaginase-based treatment, were not eligible for it, or could not tolerate it

Additional criteria for the Golcaza sub-study only:

• People who have a locally confirmed diagnosis of follicular helper T-cell lymphoma (a specific subtype), classified under 2022 medical guidelines, confirmed by a surgical or needle biopsy of a lymph node — including the angioimmunoblastic type, follicular T-cell type, or "not otherwise specified" type
• People with a general health score (ECOG) of 0 or 1 (this replaces the general health score requirement listed in the main criteria above)
• People whose blood clotting test results are within acceptable ranges, unless they have been on a stable blood-thinning medication for more than 3 months following a clotting event (confirm with trial site for specific values)
• Women who could become pregnant must have two negative pregnancy tests (one 10–14 days before starting treatment and one within 24 hours before starting), and must use two methods of contraception including at least one highly effective method, starting at least 28 days before the first dose, continuing during treatment, and for at least 28 days after the last dose of one study drug and 6 months after the last dose of another — they must also not donate eggs during this time
• Men must use a condom combined with a highly effective contraceptive method (or remain abstinent) with partners who could become pregnant, and must use a condom or remain abstinent with pregnant partners, during treatment and for at least 28 days after the last dose of one study drug and 3 months after the last dose of another — they must also not donate sperm during this time

Who may not be able to join:

General exclusion criteria (all participants):

• People whose lymphoma has spread to the brain or spinal cord
• People with significant medical conditions, unusual laboratory results, or mental health conditions that the study doctor believes would interfere with participation
• People with an uncontrolled fungal, bacterial, or viral infection
• People with active Hepatitis B or Hepatitis C infection, where the virus is detectable in the blood
• People with another active cancer diagnosis, unless that cancer has been in full remission for at least 2 years — people with a history of certain treated skin cancers or early-stage cancers that were fully treated may still be considered eligible (confirm with trial site)
• People who have received any standard or experimental cancer treatment within 28 days (or within a minimum of 5 half-lives of that drug, whichever is shorter) before the first dose of the study drug
• People who have taken steroid medications (such as prednisone) within 14 days before the first study dose, unless the total amount taken during that time was at or below a low daily equivalent dose (confirm with trial site for the specific threshold)
• People who had a stem cell transplant using their own cells less than 3 months before starting the study drug; or more than 3 months ago but still have unresolved side effects above a mild level from that transplant
• People who had a stem cell transplant using donor cells less than 3 months before starting the study drug; or more than 3 months ago but still have unresolved side effects, are still on immune-suppressing medication, or have more than mild graft-versus-host disease
• People who had major surgery within 14 days before starting the study drug, or who have not fully recovered from recent surgery
• People who received localised cancer treatment (such as radiation therapy) within 14 days before starting the study drug
• People with a known or suspected allergy or sensitivity to the study drug or any of its ingredients
• People who are pregnant, planning to become pregnant, or currently breastfeeding
• People who are legally detained or have had their freedom restricted by a court or administrative decision

Additional exclusion criteria for the Origina-ly-T sub-study only:

• People who test positive for HIV at the screening stage — with the exception that people who are HIV-positive may still be considered eligible if they have been on stable HIV treatment for at least 4 weeks, have an adequate immune cell count, have an undetectable viral load, and have not had a serious HIV-related infection in the past 12 months (confirm with trial site)
• People with significantly reduced kidney function or significantly impaired liver function based on blood test results — some exceptions may apply in cases of a specific inherited liver condition (Gilbert's Syndrome) or if the abnormality is caused by the lymphoma (confirm with trial site)
• People with serious heart problems, including a heart attack in the past 6 months, unstable heart rhythm, or unstable chest pain
• People who have previously been treated with a specific type of drug called a PI3K-delta inhibitor
• People with a known allergy or intolerance to the specific study drug used in this sub-study (roginolisib) or its ingredients
• People who cannot swallow food or tablets, or have a condition affecting the upper digestive system that would prevent taking oral medications
• People diagnosed with cutaneous T-cell lymphoma (a type of lymphoma affecting the skin)
• People who have previously had a solid organ transplant (such as a kidney, liver, or heart transplant)

Additional exclusion criteria for the GolcAza sub-study only:

• People who test positive for HTLV-1 (a specific virus) at screening
• People who test positive for HIV at the screening stage — with the same exception as described in the Origina-ly-T sub-study above (confirm with trial site)
• People with significantly reduced kidney function or significantly impaired liver function based on blood test results — some exceptions may apply for a specific inherited liver condition or if caused by the lymphoma (confirm with trial site)
• People who have previously been treated with golcadomide (one of the study drugs)
• People whose lymphoma did not respond at all to previous treatment with azacitidine (another study drug)
• People with serious heart problems, including a heart attack or unstable chest pain within the past 3 months, certain heart rhythm or electrical problems, or a heart rhythm measurement (QTcF) at or above a specific level on screening (confirm with trial site)
• People who have taken certain medications that strongly affect how the body processes drugs (specific enzyme inhibitors or inducers) within 7 days before starting the study treatment (confirm with trial site for specific drug names)
• People who have received a live or live-attenuated vaccine within 6 months before joining the trial
• People with a known allergy or intolerance to azacitidine, golcadomide, or any of their ingredients
• People with a known condition that affects the body's ability to absorb nutrients or medications from the digestive system

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