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 one of the following blood cancers confirmed by tissue testing: Diffuse Large B Cell Lymphoma (DLBCL), Primary Mediastinal B Cell Lymphoma, Follicular Lymphoma that has transformed into a more aggressive form, High Grade B Cell Lymphoma (excluding a specific subtype called B-lymphoblastic lymphoma), Mantle Cell Lymphoma, or Burkitt Lymphoma — some of these subtypes require insurance approval and confirmed CD19 protein on the cancer cells
• People whose lymphoma falls into one of these situations: it did not respond to initial strong chemotherapy; it came back and did not respond to at least two cycles of a second round of chemotherapy; or it came back after a stem cell transplant (at least 3 months must have passed since the transplant)
• People who have at least one lymphoma lesion large enough to measure — at least 1.5 cm for lymph node involvement, or at least 1.0 cm for lymphoma outside the lymph nodes
• People whose lymphoma cells test positive for a protein called CD19 (if a previous treatment targeted CD19, a new tissue sample is needed to confirm this)
• People whose general physical health is rated at a level of 0, 1, or 2 on a standard medical performance scale, meaning they are able to carry out at least some daily activities (confirm with trial site)
• People aged 18 to 80 years old
• People whose kidneys are functioning at a sufficient level, measured by a standard calculation (confirm with trial site)
• People whose liver function blood test results are within acceptable ranges — slightly different limits may apply for people with a condition called Gilbert syndrome or if lymphoma has spread to the liver (confirm with trial site)
• People whose heart is pumping at least 45% of its capacity, as measured by an ultrasound or similar heart scan
• People whose blood oxygen level on room air is at least 94%, measured by a finger sensor
• People whose blood counts on the day of screening meet minimum levels for white blood cells, red blood cells, lymphocytes, and platelets (confirm with trial site)
• People who have not received blood or platelet transfusions, or certain blood-boosting medications, for at least 5 days before eligibility is formally assessed
• People who are willing and able to sign a consent form, attend required clinic visits and lab tests, be hospitalised when needed, and undergo required procedures as directed by the treating doctor
• Women who either have a negative pregnancy blood test, or who can confirm they have gone through menopause, or have had their uterus or ovaries surgically removed
• All participants who are capable of having children, whether male or female, who agree to use effective contraception during treatment and for at least one year after the last treatment

Who may not be able to join:

• People with certain specific subtypes of lymphoma that are biologically different or less likely to respond to this treatment, including EBV-positive DLBCL, plasmablastic lymphoma, primary effusion lymphoma, ALK-positive large B cell lymphoma, intravascular large B cell lymphoma, DLBCL associated with chronic inflammation, lymphomatoid granulomatosis, T cell/histiocyte-rich large B cell lymphoma, or Richter transformation of a blood cancer called CLL
• People whose lymphoma has started in the brain or spinal cord, or has spread there
• People with certain brain or nervous system conditions that increase the risk of serious side effects, including active seizure disorder currently requiring medication, diseases that damage the nerve coating (such as multiple sclerosis), a stroke within the past 2 years, neurodegenerative conditions such as Alzheimer's or Parkinson's disease, or swelling or fluid buildup in the brain
• People who have had an invasive cancer (other than certain early-stage or non-spreading skin cancers, cervical pre-cancer, or a closely monitored low-risk prostate cancer) within the past 3 years
• People who have had a heart attack, unstable chest pain, or a heart procedure to open blocked arteries within the past 6 months, or who have stable chest pain requiring nitrate medication
• People with high blood pressure that cannot be controlled to below 160/100 even with up to three blood pressure medications
• People with an uncontrolled serious infection, including certain fungal infections, or with certain viral infections above specified levels in the blood (confirm with trial site)
• People with a history of a serious immune overactivation condition called macrophage activation syndrome (MAS) or hemophagocytic lymphohistiocytosis (HLH), or with a known or suspected long-term active Epstein-Barr virus infection
• People living with HIV whose virus is not well controlled (those with HIV whose viral levels have been very low for the past 3 months and who remain on at least 3 antiviral medications may still be considered — confirm with trial site)
• People with hepatitis B that is not suppressed to very low levels with appropriate antiviral medication, or those with past exposure to hepatitis B who are not on suppressive therapy
• People with active hepatitis C and ongoing liver problems — those who have cleared the virus with previous treatment may be considered if liver function is confirmed to be adequate by a specialist (confirm with trial site)
• People with certain autoimmune or inflammatory conditions (such as rheumatoid arthritis, lupus, severe psoriasis, inflammatory bowel disease, certain lung inflammation conditions, autoimmune liver or brain disease, or kidney inflammation with significant protein loss) that require medications stronger than specified low-level treatments — some conditions such as well-controlled thyroid conditions or well-managed Addison's disease with low-dose steroids may be considered (confirm with trial site)
• People with immune system deficiencies other than two specific mild types (common variable immunodeficiency or IgA deficiency)
• People who have external drainage tubes in place (such as around the heart, lungs, abdomen, bile ducts, or kidneys)
• People taking prednisone (a steroid) at more than 10 mg per day, or taking any other systemic immune-suppressing medication
• People who have received certain immune-based therapies, chemotherapy within 21 days, or radiation within 14 days before the first dose of the study drug (confirm with trial site)
• People whose immune system has developed antibodies that make platelet transfusions ineffective
• People on blood thinners or antiplatelet medications that cannot be stopped — low-dose aspirin up to 100 mg per day may be continued under certain conditions (confirm with trial site); people who have had a blood clot in a vein or the lungs within the past 3 months are not eligible
• People with heart failure symptoms due to heart conditions beyond reduced pumping function — such as valve problems, rhythm problems, or stiffening of the heart — that place them in a more limited functional category (confirm with trial site)
• People who have previously received a type of treatment called anti-CD19 CAR-T therapy
• People with uncontrolled serious mental illness or significant cognitive impairment that prevents them from making informed decisions about participation
• People who have previously had a solid organ transplant (such as a kidney, liver, or heart transplant)

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