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 aged 18 to 70 who a doctor has assessed as suitable for chemotherapy (Cohort A), or people aged 70 or older, or under 70 but assessed by a doctor as not suitable for chemotherapy (Cohort B).
• People of any gender.
• People who have been diagnosed with marginal zone lymphoma (including MALT, SMZL, or NMZL) confirmed by a tissue sample test.
• People whose lymphoma has come back, gotten worse after local treatment (such as surgery, radiation, or treatment for Helicobacter pylori or hepatitis C), or who are not suitable for local treatment.
• People with an ECOG performance score of 0 to 3 (a measure of how well a person can carry out daily activities); if the score is 3, a doctor must confirm the reduced fitness is mainly due to the lymphoma itself.
• People who have clear signs that treatment is needed, such as fever/night sweats/weight loss, low blood cell counts, bleeding, a large tumour mass, or rapidly growing disease.
• People whose major organ functions meet specific blood and biochemistry test thresholds set by the trial (confirm with trial site for exact values).
• People with a life expectancy of at least 3 months.
• People who are willing to sign a written consent form before the trial begins.

Who may not be able to join:

• People who currently have, or have previously had, another cancer — unless it was fully treated and there has been no sign of it returning or spreading in the past 5 years.
• People whose lymphoma has spread to the brain or spinal cord, or whose lymphoma has changed into a more aggressive (higher-grade) type.
• People with serious or uncontrolled heart conditions, including: certain types of heart failure, unstable chest pain, a heart attack within the past 6 months, heart rhythm problems requiring treatment with reduced heart pumping function, certain inherited heart muscle diseases, a history of significantly abnormal heart electrical activity, coronary artery disease causing symptoms or requiring medication, or high blood pressure that cannot be controlled even with multiple medications.
• People who have had active bleeding in the 2 months before screening, are currently taking blood-thinning medications, or who a doctor believes have a clear tendency to bleed.
• People who have had a blood clot in a deep vein or in the lungs within the past 6 months.
• People with significant digestive system problems that could affect how a tablet is swallowed or absorbed (such as an inability to swallow, severe ongoing diarrhoea, or bowel blockage), or people who have had their entire stomach surgically removed.
• People who have previously had an organ transplant or a bone marrow transplant using donor cells.
• People who have had major surgery (requiring general anaesthetic) within 6 weeks before screening, or minor surgery within 2 weeks before screening (note: insertion of a vascular access device and diagnostic endoscopies are not counted as major surgery for this purpose).
• People with an active infection, uncontrolled hepatitis B, hepatitis C antibodies, HIV/AIDS, or other serious infectious diseases.
• People who currently have serious lung conditions such as pulmonary fibrosis, interstitial pneumonia, radiation-related lung damage, or drug-related lung inflammation that significantly affects lung function.
• People who have previously been treated with certain targeted therapies known as BTK inhibitors, BCR pathway inhibitors (such as PI3K or Syk inhibitors), or BCL-2 inhibitors.
• People who are pregnant, breastfeeding, or of childbearing potential and unwilling to use contraception during the trial.
• People who need to take certain medications on an ongoing basis that significantly affect the way the trial drug is processed by the body (confirm specific medications with the trial site).
• People who the trial investigators consider unsuitable for any other reason.

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