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 formally diagnosed with Waldenstrom's macroglobulinemia (WM) or lymphoplasmacytic lymphoma (LPL), with a measurable level of IgM protein in the blood (at least 500 mg/dL).
• People whose baseline disease tests were completed within 28 days before signing up for the trial.
• People who have at least one reason that their doctor has determined they need treatment for WM, such as low red blood cell counts (anemia), low platelet counts, nerve problems caused by WM, thickened blood causing symptoms, kidney problems linked to WM, bulky disease, or general symptoms like significant unintentional weight loss, unexplained fevers, night sweats lasting more than a month, or severe ongoing fatigue.
• People who are 18 years of age or older.
• People who have had a physical exam and medical history review within 28 days before signing up.
• People who are reasonably active and able to care for themselves, as assessed by a standard medical scale (Zubrod performance status of 2 or below).
• People whose kidneys are functioning well enough, based on a blood test done within 14 days before signing up.
• People whose liver function blood tests are within acceptable ranges, tested within 14 days before signing up.
• People whose platelet count, hemoglobin (a measure of red blood cells), and white blood cell counts meet minimum levels, tested within 14 days before signing up (blood transfusions or growth factor support are allowed up to 7 days before signing up).
• People living with HIV, provided they are on effective HIV treatment and have had an undetectable viral load within the past 6 months.
• People who are able to swallow capsules whole and do not have significant stomach or bowel problems that could affect how the study drug is absorbed.
• People who have had a previous cancer may still be eligible if that cancer was adequately treated and they have been cancer-free for at least two years, or if it was an early-stage skin cancer or early cervical cancer, or if the treating doctor considers the cancer cured with minimal chance of return within 5 years (confirm with trial site).
• People who are willing to have biological samples (such as blood or tissue) stored for research purposes.
• People who have been informed about the research nature of this study and have signed a consent form agreeing to participate.

Who may not be able to join:

• People who are currently taking, or have taken within 7 days before starting the study drug, certain medications that strongly affect how the body processes drugs (known as moderate or strong CYP3A inducers or inhibitors, or P-gp inhibitors) — unless they can safely switch to a different medication.
• People who have previously received systemic (whole-body) treatment for WM, except that prior treatment with rituximab is allowed if the last dose was at least 6 months before signing up.
• People who cannot tolerate rituximab.
• People who have an active infection (other than minor localised skin or nail fungal infections), or who have recently needed intravenous antibiotics or a hospital stay for an infection within 4 weeks before signing up.
• People who have tested positive for hepatitis C, unless they have completed antiviral treatment and had an undetectable viral load for at least 12 weeks after finishing that treatment.
• People who are pregnant or breastfeeding, because one of the study drugs (venetoclax) is expected to be harmful to an unborn baby. People who could become pregnant are required to use effective contraception during the study and for at least 30 days after finishing treatment.
• People who have eaten grapefruit, Seville oranges, or starfruit within 3 days before the first dose of venetoclax.
• People who have a significant condition affecting the stomach or bowel (such as ulcerative disease, uncontrolled nausea, vomiting, diarrhoea, malabsorption, or a history of small bowel removal) that could affect how the study drug is absorbed.

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