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 or older.
• People with a life expectancy of at least 6 months.
• People with a laboratory-confirmed diagnosis of Mantle Cell Lymphoma (MCL), showing specific genetic or protein markers associated with the disease.
• People with Stage II, III, or IV MCL that can be measured on a CT scan or through blood/bone marrow tests.
• People with a "slow-growing" or "indolent" form of MCL, meaning at least one of the following applies: the disease was monitored without treatment for at least 6 months after diagnosis; the MCL affects mainly the blood and spleen without involving lymph nodes; or the tumours are small, show low cell growth activity, and have a standard cell appearance (confirm with trial site).
• People with a general health and activity level rated 0, 1, or 2 on a standard medical scale, meaning they are fully active to capable of limited self-care (confirm with trial site).
• People with blood counts (white cells and platelets) above certain minimum levels, without needing growth-stimulating medications to achieve this.
• People whose liver enzyme levels (AST and/or ALT) are within an acceptable range.
• People whose bilirubin (a liver-related substance) levels are within an acceptable range, unless the raised level is due to a harmless inherited condition or is directly caused by the MCL.
• People whose kidneys are functioning at or above a minimum level, based on a standard calculation or measurement.
• People who are able to give their own voluntary written consent to participate.
• People who are willing and able to attend all required study visits and procedures, including being able to swallow capsules.
• Women who could potentially become pregnant must have a negative pregnancy test before joining.
• People who are willing to follow the trial's contraception requirements during the study.

Who may not be able to join:

• People who have previously received any treatment for MCL, including radiotherapy.
• People whose MCL has spread to the brain or spinal cord.
• People with a poorly controlled HIV infection, or any active uncontrolled infection (bacterial, viral, or fungal). People with well-controlled HIV (undetectable viral load) are not automatically excluded.
• People with certain Hepatitis B or C infection markers in their blood, depending on specific test results (confirm with trial site for individual circumstances).
• People whose MCL has not progressed to a point where treatment is needed since their initial diagnosis.
• People who have received a live vaccine (not including mRNA or viral vector COVID-19 vaccines) within the four weeks before joining the trial.
• People who have had major surgery within 28 days before joining the trial, or who have not fully recovered from a recent surgery.
• People with another cancer that is currently being treated, or a past cancer that has not been in remission for at least 2 years — with some exceptions for certain low-risk skin cancers and other specific cancers (confirm with trial site).
• People who require certain medications that strongly interfere with how the trial drug is processed by the body (known as moderate or strong CYP3A inducers) (confirm with trial site).
• People who require warfarin or similar blood-thinning medications (some alternative blood thinners may be permitted — confirm with trial site).
• People with active bleeding, a history of a bleeding disorder (such as haemophilia), or a history of spontaneous bleeding that required medical treatment.
• People with significant heart problems, including uncontrolled irregular heartbeat, certain serious heart rhythm conditions, a heart attack within the past 6 months, severe heart failure, abnormal heart electrical readings, or unstable chest pain within the past 3 months (confirm with trial site).
• People who have had a stroke or bleeding in the brain within the past 6 months.
• People with any other serious medical or psychiatric condition that, in the treating doctor's opinion, would interfere with safe participation in the trial.
• People with conditions that affect the absorption of medications, including difficulty swallowing capsules, significant bowel or stomach disease, bowel obstruction, or certain prior stomach or bowel surgeries such as gastric bypass.
• Women who are pregnant or breastfeeding.
• Male participants whose female partners could become pregnant, if those participants are unwilling to use appropriate contraception.
• People currently receiving another experimental treatment as part of a different study.
• People with a history of severe allergic reactions to certain types of antibody-based treatments, or known sensitivity to products derived from mice.
• People with a known allergy or sensitivity to any ingredient in the trial medications.
• People with severe or debilitating lung disease.
• People with underlying health conditions that, in the treating doctor's opinion, would make receiving the study drug unsafe or make it difficult to assess side effects.
• People currently participating in another therapeutic clinical trial.
• People with active autoimmune conditions that cause the immune system to attack their own red blood cells or platelets (such as idiopathic thrombocytopenic purpura).

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