Phase 1 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 given documented informed consent to participate
• People aged 18 or older at the time of signing the consent form
• People whose general physical functioning is rated as reasonably good by their doctor (a standard performance scale called ECOG, scored 0, 1, or 2)
• People who self-identify as Black or African American, Hispanic or Latino, American Indian or Native Alaskan, Pacific Islander or Native Hawaiian, or any other racial/ethnic group not listed in Cohort 2 (Cohort 1); OR people who self-identify as Non-Hispanic White or Non-Hispanic Asian (Cohort 2)
• People who have a confirmed diagnosis of one of the following blood cancers:
  • Diffuse large B cell lymphoma (DLBCL): Cancer that has come back or stopped responding to at least 2 previous treatments, and where the treating doctor considers further standard therapies (such as CAR-T cell or bispecific antibody therapy) either not suitable or already tried
  • Follicular lymphoma (FL, grades 1, 2, or 3a): Cancer that has come back or stopped responding to at least 1 previous treatment, with active disease needing treatment
  • Marginal zone lymphoma (MZL): Cancer that has come back or stopped responding to at least 1 previous treatment, with active disease needing treatment
  • Mantle cell lymphoma (MCL): Cancer that has come back or stopped responding to at least 1 previous treatment, and where the treating doctor believes treatment is needed
  • Chronic lymphocytic leukaemia or small lymphocytic lymphoma (CLL/SLL): Either newly diagnosed or having come back or stopped responding to at least 1 previous treatment, where the treating doctor determines treatment is needed
• People whose cancer can be measured by imaging scans or specific blood/laboratory tests, meeting defined size thresholds
• People with a life expectancy of at least 6 months
• People with blood count results (white cells, platelets, and haemoglobin) that meet minimum levels set by the trial (the specific thresholds depend on whether the cancer has spread to the bone marrow — confirm exact values with the trial site)
• People with liver function test results within acceptable ranges (specific limits apply — confirm with trial site)
• People with adequate kidney function as measured by a standard formula or urine test
• People with a normal enough heart electrical reading (QT interval) on an ECG, measured within 28 days before starting treatment
• People who test negative for HIV, hepatitis B, and hepatitis C — OR, if positive for any of these, people whose virus levels are undetectable; people living with HIV who are on effective treatment with an undetectable viral load within the past 6 months may also meet this criterion
• Women who could become pregnant must have a negative pregnancy test before starting the trial
• People of childbearing potential (men and women) who agree to use effective contraception or abstain from heterosexual activity during the trial and for at least 90 days after the last dose

Who may not be able to join:

• People who have had major surgery within 4 weeks before the first dose
• People who have had a stem cell transplant using their own cells less than 30 days ago, or CAR-T cell therapy less than 30 days ago
• People who have had a stem cell transplant using a donor's cells and currently have active graft-versus-host disease, are on immune-suppressing drugs for it, or have taken certain related medications (calcineurin inhibitors) within the past 4 weeks
• People who have been on a BCL2 inhibitor (such as venetoclax) for 2 months or more, or whose cancer progressed while on one
• People who have received a live vaccine within 35 days before the first dose, or who would need one during the trial
• People who require ongoing treatment with a strong CYP3A inducer (a type of medication that affects how other drugs are processed in the body — confirm with trial site)
• People who require ongoing treatment with warfarin or similar blood-thinning medications
• People currently participating in another therapeutic clinical trial
• People who have recently received certain treatments before the first dose, including:
  • Biologic or immunologic cancer therapies (such as monoclonal antibodies like rituximab or cancer vaccines) within the past 28 days
  • Chemotherapy or radiation therapy within the past 14 days
  • Steroids given to treat cancer within the past 7 days (with a specific exception — confirm with trial site)
  • Targeted cancer medications such as BTK inhibitors or similar drugs within 5 half-lives of the drug (confirm timing with trial site)
• People whose lymphoma or leukaemia has spread to the central nervous system (brain or spinal cord)
• People with certain related blood conditions, including plasma cell neoplasm, prolymphocytic leukaemia, or Richter's syndrome (a transformation of CLL into a more aggressive lymphoma)
• People with serious, uncontrolled heart problems, including a heart attack within the past 6 months, severe heart failure, unstable chest pain within the past 3 months, significant heart rhythm problems, or certain types of heart block without a pacemaker
• People who have had another cancer within the past 3 years — with some exceptions, such as certain skin cancers, non-invasive bladder cancer, early-stage cervical or breast cancer in place only, or low-risk prostate cancer that was treated with the aim of cure
• People with a history of serious bleeding disorders such as haemophilia or von Willebrand disease, or a history of severe spontaneous bleeding
• People who have had a stroke or bleeding in the brain within the past 6 months
• People with severe or debilitating lung disease
• People who cannot swallow capsules, or who have significant problems with the digestive system that could affect how the drug is absorbed (such as previous stomach removal, bariatric surgery, inflammatory bowel disease, or bowel obstruction)
• People with an active infection (fungal, bacterial, or viral) currently requiring treatment
• People with other underlying health conditions that, in the treating doctor's judgement, would make the study drugs unsafe or make it difficult to assess side effects
• People with active hepatitis B or C infection (specific laboratory marker criteria apply — confirm with trial site)
• People with any condition that, in the treating doctor's opinion, would prevent them from being able to follow the study procedures
• People with a known history of allergic reactions to medications similar in composition to the study drugs
• People with active autoimmune conditions causing the immune system to attack their own red blood cells or platelets
• People who are pregnant or breastfeeding
• People who, in the treating doctor's opinion, may not be able to reliably follow all study procedures

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