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 who are physically well enough to carry out basic daily activities (based on a standard medical scale called ECOG, scored 0 to 2), assessed within 7 days before starting the study treatment
• People whose doctor estimates they have a life expectancy of at least 3 months
• People who are able to swallow and keep down oral (tablet/capsule) medication
• People who have been diagnosed with chronic active Hepatitis B, provided they have been on antiviral treatment for at least 4 weeks and the virus is no longer detectable in their blood before the study begins
• People with a history of Hepatitis C infection, provided the virus is no longer detectable in their blood at the screening stage
• People whose kidneys, liver, and other organs are working at an adequate level (confirm with trial site for specific values)
• Male participants who agree not to donate sperm and who agree to either abstain from penile-vaginal intercourse or use contraception during the treatment period and for a set time after the last dose
• Female participants assigned female sex at birth who are not pregnant or breastfeeding, and who either cannot become pregnant, or who agree to use a highly effective form of contraception or abstain from penile-vaginal intercourse during treatment and for a set time after the last dose
• People living with HIV, provided their CD4 immune cell count is above 350 cells per microlitre, the HIV virus is undetectable in their blood, they have been on a stable HIV treatment regimen for at least 4 weeks before joining, and they are consistently taking their HIV medication

For specific parts of the trial, the following disease-related criteria also apply:

• People with a confirmed diagnosis of Chronic Lymphocytic Leukaemia (CLL) or Small Lymphocytic Lymphoma (SLL) who have already received at least 2 prior treatments (Part 1 only)
• People with CLL/SLL whose disease has come back or stopped responding after treatment with two specific types of targeted therapies (BTK inhibitor and BCL2 inhibitor), and who have also tried, been unable to tolerate, or been assessed by their doctor as unsuitable for another class of therapy called PI3K inhibitors (Part 2, Cohort A)
• People with CLL/SLL whose disease has come back or stopped responding after at least one prior treatment, and who have never received a BTK inhibitor (Part 2, Cohort B)
• People with CLL/SLL who have a specific genetic change (17p deletion or TP53 mutation) and whose disease has come back or stopped responding after at least one prior treatment (Part 2, Cohort C)
• People with CLL/SLL whose disease has come back or stopped responding after treatment with both a covalent BTK inhibitor and a BCL2 inhibitor (Part 2, Cohort J); a subgroup of at least 10 participants must also have received a third type of BTK inhibitor (non-covalent/reversible)
• People with Richter's transformation whose disease has come back or stopped responding after at least one prior treatment (Part 2, Cohort D)
• People with confirmed Mantle Cell Lymphoma (MCL) whose disease has come back or stopped responding after both chemotherapy-based treatment and a covalent BTK inhibitor (Part 2, Cohort E)
• People with Marginal Zone Lymphoma (MZL) — including splenic, nodal, and extra-nodal types — whose disease has come back or stopped responding after at least one prior treatment that included an anti-CD20 therapy (Part 2, Cohort F)
• People with Follicular Lymphoma (FL) whose disease has come back or stopped responding after both chemotherapy-based treatment and an immunomodulatory treatment such as a lenalidomide-based regimen (Part 2, Cohort G)
• People with Waldenström's Macroglobulinaemia (WM) whose disease has come back or stopped responding after standard treatments, including chemotherapy-based treatment and a covalent BTK inhibitor (Part 2, Cohort H)
• People with measurable disease that can be detected and measured on CT scans (required for several cohorts; confirm specific measurement requirements with trial site)
• People who are able to provide a tissue sample (biopsy or bone marrow sample) for analysis, as required depending on the specific cohort

Who may not be able to join:

• People with a currently active Hepatitis B or Hepatitis C infection
• People who have been diagnosed with another cancer in the past 3 years (with some exceptions: people with certain skin cancers or pre-cancerous conditions that have been treated with the aim of cure may still be eligible, as may people with low-risk, early-stage prostate cancer either treated or being monitored — confirm with trial site)
• People with cancer that has spread to or is active in the brain or spinal cord (central nervous system)
• People who currently have an active infection that requires treatment with systemic (whole-body) medication
• People who have received cancer treatment within the past 4 to 5 weeks before starting the study (the exact timeframe depends on the type of treatment previously received)
• People who are currently taking part in, or have recently taken part in, another clinical trial involving an experimental treatment or device within the past 4 weeks
• People with significant digestive system problems that could affect how the body absorbs the study medication
• People with a history of severe bleeding disorders

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