Phase 2 Leukaemia 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 diagnosed with Chronic Lymphocytic Leukaemia (CLL) or Small Lymphocytic Lymphoma (SLL) according to standard medical criteria.
• People whose CLL or SLL has reached a point where treatment is considered necessary according to established medical guidelines.
• People who have not previously received systemic (whole-body) treatment for CLL or SLL, with limited exceptions: prior localised radiation therapy for symptoms is permitted, and a short course of steroid medication (no longer than 14 days, at or below a specified dose) that has been stopped before the trial begins is permitted.
• People aged 18 years or older.
• People with a general health and activity level rated at 0, 1, or 2 on a standard medical scale (meaning someone who is fully active, has some limitations but can care for themselves, or is capable of self-care but unable to work) (confirm with trial site).
• People whose blood counts and organ function meet specific minimum levels — including white blood cell counts, platelet counts, liver function results, and kidney function — as measured by blood tests.
• Women who could become pregnant must have a negative pregnancy blood test during the screening period.
• Women who could become pregnant must agree to use highly effective contraception, or remain abstinent, during treatment and for a specified period after the last dose of each study drug (at least 30 days after the last dose of zanubrutinib, 90 days after sonrotoclax, or 18 months after obinutuzumab — whichever is latest).
• Men whose female partner could become pregnant, or whose partner is pregnant, must agree to use a condom plus one additional highly effective contraceptive method, or remain abstinent, during treatment and for the same specified periods after the last dose of each study drug.
• People who are willing not to donate or bank sperm or eggs during the entire treatment period and for the specified periods after the last dose of each study drug.
• People who are able to understand the study and are willing to sign a written consent form.

Who may not be able to join:

• People whose CLL or SLL has transformed into a more aggressive type of lymphoma (known as Richter's transformation).
• People whose CLL or SLL has spread to the central nervous system (brain or spinal cord).
• People who have had another active cancer diagnosis or received systemic treatment for another cancer within the past 2 years (some exceptions may apply — confirm with trial site).
• People with an uncontrolled medical condition that the trial doctor believes would make it unsafe to receive the study treatment, such as serious active infections, uncontrolled high blood pressure, chest pain, abnormal heart rhythms, significant lung disease, or autoimmune conditions.
• People with serious heart conditions, including severe heart failure, unstable chest pain in the past 3 months, a heart attack in the past 6 months, a history of certain serious heart rhythm problems, a specific abnormality on a heart electrical test (QT interval above a set threshold), or a history of certain heart conduction problems without a pacemaker in place.
• People who have received a live-virus vaccine within 28 days before starting the trial, or who would need a live-virus vaccine during the trial.
• People with a current active infection (bacterial, viral, fungal, or other — excluding minor nail fungal infections).
• People with a known bleeding disorder or a history of a severe bleeding condition such as haemophilia or von Willebrand disease, or a history of serious spontaneous bleeding requiring medical treatment.
• People who have had major surgery within 4 weeks before the trial, or who are expected to need major surgery during the trial.
• People who have had bleeding in the brain or a stroke within the past 6 months.
• People with a history of a serious brain condition called progressive multifocal leukoencephalopathy.
• People with a history of HIV infection (with exceptions for those whose HIV is well controlled on medication and meets specific blood test criteria — confirm with trial site), active hepatitis B, or active hepatitis C (some exceptions apply for people with past or inactive hepatitis B or C — confirm with trial site).
• People who are unable to swallow oral (by mouth) medications, or who have a condition that would prevent oral medications from being absorbed properly.
• People currently participating in another investigational treatment trial (unless specifically approved by the lead trial doctor).
• People currently taking, or who have recently taken, certain medications that significantly affect how the body processes drugs (moderate or strong inhibitors or inducers of a liver enzyme called CYP3A) within 5 half-lives of that drug or 14 days before starting the trial, whichever is shorter.
• People currently taking the blood-thinning medication warfarin or related drugs.
• People currently taking two antiplatelet medications at the same time (dual antiplatelet therapy).
• People who have previously received systemic treatment for CLL or SLL (beyond the limited exceptions described in the inclusion criteria).
• People who have previously received anti-CD20 antibody therapy (a specific type of treatment) for any reason.
• People with a known serious allergic reaction to any of the three study drugs (obinutuzumab, zanubrutinib, or sonrotoclax) or their ingredients.
• People who have consumed grapefruit, Seville oranges (including marmalade made with Seville oranges), or star fruit within 3 days before starting the study drug.
• People with a known psychiatric illness or personal circumstances that would make it difficult to follow the study requirements.
• People who are pregnant or breastfeeding.
• People with autoimmune anaemia or autoimmune low platelet counts that are not well controlled, for example requiring ongoing steroid treatment.
• People who currently require ongoing corticosteroid (steroid) treatment — steroids must be fully stopped before the first study drug dose.
• People with uncontrolled high blood pressure at the screening stage, defined as two consecutive measurements showing blood pressure above a specified threshold (systolic above 170 mmHg and diastolic above 105 mmHg).

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