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:

• Adults aged 18 or older
• People with previously untreated follicular lymphoma (grade 1–3a) with a low amount of disease spread, as measured by specific medical guidelines called GELF criteria
• People with previously untreated follicular lymphoma (grade 1–3a) with a high amount of disease spread (by GELF criteria), but who are unable or unwilling to receive the usual first-line treatments
• People with previously untreated marginal zone lymphoma, lymphoplasmacytic lymphoma, or another slow-growing B-cell blood cancer, with a low amount of disease spread or who are unable or unwilling to receive more intensive standard treatments
• People with previously untreated mantle cell lymphoma who would normally be suitable for a "watch and wait" approach, or who have symptoms but are not able to receive or do not want standard initial treatment
• People with low-disease-burden follicular lymphoma must have at least one affected lymph node or disease site that is 1.5 cm or larger in size
• All participants must have measurable or trackable disease, which the trial site can assess in one of these ways: at least one lymph node or disease site larger than 1.5 cm; confirmed disease involvement in bone marrow or blood that can be re-checked; or confirmed disease in the spleen or other sites with at least one remaining area that can be monitored after the initial biopsy
• People with a general health and activity level rated 0, 1, or 2 on a standard medical scale (meaning able to carry out daily activities, possibly with some limitations) (confirm with trial site)
• Women who could become pregnant, and men enrolled in the trial, must agree to use reliable contraception during the study and for at least 2 days after the last dose of one study drug (acalabrutinib) or 18 months after the last dose of the other study drug (obinutuzumab), whichever is longer
• Women who could become pregnant must have a negative pregnancy test before starting treatment
• People who are willing and able to attend all required study visits and follow all study procedures
• People who are able to understand the purpose and risks of the study and provide signed, informed consent

Who may not be able to join:

• People whose lymphoma has transformed into or exists alongside a faster-growing, more aggressive type of lymphoma
• People with a confirmed history of, or currently active, lymphoma involvement in the brain or central nervous system
• People who have previously received any treatment directed at their lymphoma, or any antibody-based therapy (with exceptions for certain antibiotic treatments for infection-related marginal zone lymphoma, such as for hepatitis C or H. pylori)
• People who have received a short course of steroid medication for lymphoma before enrolling — with specific rules depending on which disease group applies (confirm with trial site for details)
• People with a history of another cancer that is either currently being treated or from which they have not been cancer-free for at least 2 years — except for certain treated skin cancers, cervical pre-cancers, or other cancers unlikely to affect survival
• People with significant heart disease, such as serious heart rhythm problems, heart failure, or a heart attack within the past 6 months, or severe heart disease by standard classification (note: people with well-controlled, symptom-free atrial fibrillation may still be considered)
• People who have difficulty swallowing tablets or capsules, or who have a significant digestive condition that would prevent oral medication from being properly absorbed
• People with a known history of HIV, or who have had a significant active infection (bacterial, viral, or fungal) in the 14 days before starting the study (people with minor, uncomplicated infections being managed with oral antibiotics may still be considered)
• People with a known history of severe allergic reactions to any of the study drugs or their ingredients
• People with active bleeding or a known bleeding disorder (such as haemophilia or von Willebrand disease)
• People with uncontrolled autoimmune destruction of red blood cells (AIHA) or platelets (ITP)
• People who have been diagnosed with a stomach or intestinal ulcer by endoscopy within the past 3 months
• People who require treatment with certain medications that strongly interact with how the body processes the study drug (known as strong CYP3A4 inhibitors or inducers) (confirm with trial site for specific drugs)
• People who require or are currently taking blood-thinning medications such as warfarin or similar vitamin K antagonist drugs
• People who require proton pump inhibitor medications (such as omeprazole, esomeprazole, lansoprazole, or similar drugs) — note: people who are able to switch to a different type of acid-reducing medication may still be considered
• People who have had a stroke, brain bleed, or other significant brain blood vessel event within the past 6 months (people who had a transient ischaemic attack that has fully resolved with no ongoing symptoms may still be considered)
• People who have had major surgery within 28 days before starting the study drug (not including a biopsy taken to diagnose the lymphoma)
• People with certain hepatitis B or hepatitis C blood test results indicating active infection — specific testing will determine eligibility, and the trial site will assess this on a case-by-case basis (confirm with trial site)
• People whose blood test results show a neutrophil count below 1,000/mcL (a measure of infection-fighting white blood cells)
• People whose platelet count is below 50,000/mcL, unless this is believed to be caused directly by the underlying disease
• People with significantly elevated bilirubin, liver enzyme (AST/ALT), or reduced kidney function levels on blood tests, beyond specific thresholds (confirm with trial site for exact values)
• People who are pregnant or breastfeeding
• People who are currently participating in another treatment-based clinical trial

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