Phase 3 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 diagnosed with classic follicular lymphoma (a type of slow-growing blood cancer), confirmed by a tissue sample test. This includes some uncommon forms of follicular lymphoma.
• People whose follicular lymphoma is considered "low tumour burden," meaning: no single tumour mass is larger than 7 cm; no more than 3 affected sites are larger than 3 cm; there are no significant symptoms such as unexplained fever, heavy night sweats, or unintentional weight loss of more than 10% of body weight; the spleen is not causing symptoms; there is no pressure on organs such as the kidneys, eyes, or digestive system; and there is no fluid build-up in the chest or abdomen caused by the lymphoma.
• People with stage II, III, or IV follicular lymphoma. People with stage I disease may also be considered if radiation therapy is not wanted or not suitable for them.
• People who are either experiencing distress from their disease or who would prefer active treatment rather than a "watch and wait" approach.
• People who have had recent imaging scans (such as a PET-CT or CT scan) completed within 49 days before joining the trial, and who have at least one measurable area of disease larger than 1.5 cm.
• People who have never received systemic (whole-body) treatment for follicular lymphoma. Previous radiation therapy for an earlier, limited-stage diagnosis is allowed.
• People aged 18 or older at the time of registration.
• People who are well enough to carry out daily activities, as measured by a standard performance scale (Zubrod score of 0, 1, or 2) (confirm with trial site).
• People who have had a full medical check-up within 28 days before joining the trial.
• People whose recent blood test results (taken within 28 days before joining) show blood cell counts and organ function within the required ranges, including: adequate white blood cell, red blood cell, and platelet counts; liver function within acceptable limits; and kidney function showing a clearance rate of at least 30 mL/min.
• People living with HIV, provided they are on effective HIV treatment and have had an undetectable viral load on their most recent test within the past 6 months.
• People with a history of hepatitis B, provided the virus is undetectable on suppressive therapy, based on test results within the past 6 months. People at high risk of hepatitis B reactivation must be receiving preventive antiviral medication before and throughout treatment.
• People with a history of hepatitis C who have been successfully treated and cured, or who are currently being treated and have an undetectable viral load on their most recent test within the past 6 months.
• People who have given their informed consent to participate. For those unable to make their own decisions, a legally authorised representative may provide consent on their behalf.

Who may not be able to join:

• People whose follicular lymphoma has specific aggressive features, including "blastoid" or "large centrocyte" cell types, or who have follicular large B-cell lymphoma (previously called grade 3B follicular lymphoma).
• People who have previously received systemic treatment (such as chemotherapy or immunotherapy) for follicular lymphoma.
• People with an active or uncontrolled infection at the time treatment would begin.
• People with uncontrolled diabetes within 14 days before registration.
• People with uncontrolled high blood pressure within 14 days before registration.
• People with autoimmune disease that requires ongoing medication to suppress the immune system.
• People who have had an organ transplant and are still on immune-suppressing medication.
• People with known chronic active Epstein-Barr virus infection.
• People who have tested positive for COVID-19 within 7 days before registration.
• People with another cancer (current or previous) that could interfere with the safety or results of this trial, in the opinion of the treating doctor.
• People with a confirmed history of a serious brain condition called progressive multifocal leukoencephalopathy (PML).
• People who have previously received an allogeneic stem cell transplant (a transplant using stem cells from another person).
• People with a history of a serious immune system condition called macrophage activation syndrome (MAS) or hemophagocytic lymphohistiocytosis (HLH).
• People with significant heart problems, including class III or IV heart disease (as classified by the New York Heart Association), a heart attack within the past 6 months, unstable heart rhythm problems, or unstable chest pain (angina).
• People who are pregnant or breastfeeding. People who are capable of becoming pregnant, or whose partners could become pregnant, must agree to use effective contraception throughout the trial.

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