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:

• People diagnosed with a specific type of lymphoma called nodal T-follicular helper cell lymphoma (nTFHL), confirmed by a tissue biopsy, including the angioimmunoblastic, follicular, or NOS subtypes as classified by current medical standards
• People who are planning to receive a stem cell transplant using their own stem cells (autologous transplant)
• People who have not yet received any treatment for this lymphoma before joining the trial
• People who have at least one measurable area of disease — a lymph node larger than 1.5 cm, or another affected area larger than 1.0 cm
• People aged 18 to 65 years old, of any gender
• People who are reasonably active and able to care for themselves, with a performance score of 2 or lower on a standard medical scale (this measures how much the illness affects daily activity)
• People with an expected survival of at least 12 weeks
• People whose bone marrow, blood counts, liver, kidneys, heart, lungs, thyroid, and immune system are all functioning at adequate levels, without having needed blood transfusions or certain blood-boosting medications in the 14 days before starting the study drug
• People with blood test results within acceptable ranges, including sufficient red blood cells, white blood cells, and platelets; liver enzyme and bilirubin levels within acceptable limits; kidney function within acceptable limits; and normal blood clotting results (or stable results if already on blood-thinning medication)
• Women of childbearing age who return a negative pregnancy test within one week before the first dose
• People who are willing and able to use effective contraception from the time they sign the consent form until six months after the last dose of the study drug (applies to women who could become pregnant, and to men whose partners could become pregnant)
• People who are willing to take part voluntarily, sign an informed consent form, and complete all trial procedures

Who may not be able to join:

• People with a known allergy to linperlisib or to any of the drugs in the CHOP chemotherapy regimen, or to their inactive ingredients
• People who have difficulty taking oral (swallowed) medications, such as those who cannot swallow, have ongoing diarrhea, or have a bowel obstruction
• People with an active, known, or suspected autoimmune disease that requires ongoing treatment (those with a stable autoimmune condition that does not require systemic medication may still be considered — confirm with trial site)
• People with a known history of a lung condition called interstitial pneumonia
• People who have had another cancer within the past two years (certain skin and cervical cancers that have been fully treated may be exceptions — confirm with trial site)
• People who have received any systemic cancer treatment — such as chemotherapy, immunotherapy, or biological therapies — within 28 days before joining the trial
• People who have previously had an autologous or allogeneic stem cell transplant
• People with active tuberculosis (TB)
• People with a serious active or ongoing infection that requires systemic treatment
• People with high blood pressure that is not well controlled by medication (systolic at or above 140 mmHg, or diastolic at or above 90 mmHg)
• People with poorly controlled diabetes (fasting blood sugar above 10 mmol/L)
• People with significant heart problems, including severe heart failure, uncontrolled coronary artery disease, certain irregular heart rhythms, or a heart attack within the six months before screening
• People who have had significant bleeding episodes in the three months before joining, such as gastrointestinal bleeding or stomach ulcers with bleeding
• People who require kidney dialysis (haemodialysis or peritoneal dialysis)
• People with significant protein in their urine at certain levels (confirm with trial site)
• People who have had major surgery or a serious injury, where the recovery period of less than 28 days has passed before joining
• People with complex interstitial lung disease or severely reduced lung function
• People who require high-dose corticosteroid tablets or other immune-suppressing medications within 14 days before starting the study drug (inhaled or topical steroids, and low-dose replacement steroids, may be acceptable in some cases — confirm with trial site)
• People who are HIV positive
• People with active hepatitis B or hepatitis C infection, or both at the same time
• Pregnant or breastfeeding women
• People with any other medical condition or history that trial investigators consider would interfere with the study or make participation inappropriate

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