Phase 3 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 a specific type of slow-growing lymphoma called follicular lymphoma (grades 1, 2, or 3a), confirmed by a tissue sample, that has not been treated before (including people who have been monitored without treatment for up to 10 years since diagnosis).
• People whose lymphoma scores between 2 and 5 on a risk scoring system called FLIPI (a tool doctors use to assess disease risk).
• People at any stage of their lymphoma, including early stage (Stage I), as long as their FLIPI score is 2 or higher.
• People whose lymphoma currently needs treatment, shown by at least one of the following: a large tumour or multiple enlarged lymph nodes; certain symptoms in the past 6 months such as unexplained fever, night sweats, or significant weight loss; an enlarged and symptomatic spleen; a painful tumour or one pressing on surrounding organs; low blood counts caused by lymphoma; fluid build-up in the chest or abdomen; or abnormal blood test results (note: the blood test criterion does not apply in Germany).
• People who have at least one measurable area of lymphoma that can be seen and tracked on scans.
• People aged 18 or older at the time of signing the consent form.
• People who are well enough to carry out most daily activities (doctors rate this on a scale of 0 to 2, where 0 means fully active and 2 means able to care for oneself but unable to work).
• People with an estimated life expectancy of at least 3 months.
• People whose blood counts meet minimum levels within 28 days before joining the trial (confirm specific values with the trial site).
• People whose kidney function, liver function, and bilirubin (a liver marker) levels are within acceptable ranges (confirm specific values with the trial site).
• People whose heart pumping function is within a normal range, as measured by a heart scan or ultrasound.
• People who are able to take blood-thinning or clot-preventing medication if needed, including those already on anticoagulant therapy for another reason, provided certain conditions are met (confirm with trial site).
• People who have tested negative for HIV, or who are HIV-positive but have been stable on HIV treatment for at least 4 weeks, have adequate immune cell levels, have an undetectable amount of virus in their blood, and have not had a serious HIV-related infection in the past 12 months.
• Women who could become pregnant must have a negative pregnancy test before joining and must agree to use reliable contraception and avoid breastfeeding throughout the study and for a set period after treatment ends (the length of time varies depending on which study drugs are used — confirm with trial site).
• Men with a pregnant partner or a partner who could become pregnant must agree to use contraception and avoid donating sperm during and after treatment for a set period (the length of time varies depending on which study drugs are used — confirm with trial site).
• People who are covered by a social security system (applicable in France only).
• People who understand and speak an official language of the country where the trial is taking place, unless an independent translator is permitted under local rules.

Who may not be able to join:

• People with a more aggressive form of follicular lymphoma called grade 3b (under the 2016 classification) or follicular large B-cell lymphoma (under the 2022 classification).
• People whose lymphoma is suspected or confirmed to have transformed into a faster-growing type of lymphoma.
• People who have previously had radiotherapy directed at the follicular lymphoma.
• People who have had a different type of lymphoma in the past.
• People with uncontrolled fluid build-up in the chest or abdomen that urgently needs treatment (within one week of being found), unless the fluid has been drained and the person has remained symptom-free, or a drainage device is in place before joining — and only after approval from the coordinating investigator (confirm with trial site).
• People with uncontrolled blockage of the tubes that carry urine from the kidneys, leading to kidney failure, unless a catheter or stent is already in place before joining (confirm with trial site).
• People who have or have had lymphoma pressing on the spinal cord or nerve roots, even if it has been controlled with steroids — these people are not eligible.
• People who have received any standard or experimental cancer treatment within 45 days before the start of the study treatment.
• People who have a known allergy or medical reason they cannot take any of the drugs used in the trial.
• People who are currently taking long-term immune-suppressing medications (such as certain arthritis or transplant drugs) or long-term steroid tablets, with some exceptions such as inhaled steroids for asthma or short-term steroids to control lymphoma symptoms before treatment begins (confirm with trial site).
• People who have received a live vaccine within 4 weeks before the first dose of study treatment, or who are expected to need one during the study or within 6 months after finishing treatment.
• People who have had major surgery within 28 days before signing the consent form (surgery to confirm the lymphoma diagnosis is excluded from this rule).
• People who have an active or significant hepatitis B infection (certain people with past exposure but no active virus may still be eligible — confirm with trial site).
• People who have an active hepatitis C infection (those with past infection but no detectable virus may still be eligible — confirm with trial site).
• People with a known or suspected allergy to any of the study drugs or their ingredients.
• People who have had a solid organ transplant or a bone marrow transplant from a donor.
• People with an active autoimmune disease (a condition where the immune system attacks the body) that requires treatment.
• People with a history of certain autoimmune diseases (a long list including lupus, rheumatoid arthritis, multiple sclerosis, and others). Some exceptions may apply for people with well-controlled thyroid conditions, well-controlled Type 1 diabetes, or a remote history of autoimmune disease with no treatment for at least 12 months (confirm with trial site).
• People with any active infection at the time of joining, including bacterial, viral, fungal, or other infections (minor nail fungal infections are excluded from this rule).
• People with other serious medical conditions that could affect their safety or the reliability of the trial results, including serious heart disease, serious lung disease, significant liver disease, or certain neurological conditions such as recent stroke or uncontrolled epilepsy (some exceptions may apply — confirm with trial site).
• People with a history of a rare and serious brain condition called progressive multifocal leukoencephalopathy (PML).
• People with a known or suspected history of a serious immune system disorder called hemophagocytic lymphohistiocytosis (HLH).
• People who have previously had a severe skin reaction to a type of drug called immunomodulatory agents.
• People with a history of lung inflammation caused by an autoimmune condition or a drug reaction.
• People who currently have another active cancer, or who have had a different cancer in the past unless they have been free of that cancer and its treatment for at least 3 years. Some exceptions apply for certain types of skin cancer, early-stage cervical, breast, or prostate cancers treated with curative intent (confirm with trial site).
• People whose lymphoma has spread to the brain or the fluid surrounding the brain and spinal cord.
• Women who are pregnant, planning to become pregnant, or currently breastfeeding.
• People with serious medical, psychological, or laboratory abnormalities that, in the doctor's judgement, make participation too risky or would make it difficult to interpret the results.
• People whose liberty is restricted by a legal or administrative order.
• People who are hospitalised without their own consent.
• Adults who are under legal guardianship or protection orders (note: in some cases, an ethics committee may review individual situations).
• People with a very high lymphocyte count (a type of white blood cell) in their blood before joining, above a level of 20 G/L (confirm with trial site).

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