Phase 2 Leukaemia 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:

• Adults aged 18 or older of any sex.
• People with a life expectancy of at least 3 months.
• People with a general health and activity level rated at 0, 1, or 2 on a standard oncology scale (confirm with trial site).
• People who have a confirmed diagnosis of chronic lymphocytic leukaemia (CLL), as classified by World Health Organization 2016 guidelines.
• People whose CLL meets at least one standard measure of detectable disease, as defined by international CLL guidelines.
• For Group 1 only: People whose CLL has partially responded to treatment but where cancer cells are still detectable in the blood or bone marrow, and who have been continuously taking the medication zanubrutinib for at least 12 months, with acceptable organ function confirmed by blood tests within 28 days before starting the trial.
• For Group 2 only: People whose CLL has come back or stopped responding to treatment, who have no other standard treatment options available, who are currently taking zanubrutinib, and whose disease progressed while on zanubrutinib within the 3 months before joining the trial — with no other cancer treatment taken since then — and with acceptable organ function confirmed within 28 days before starting the trial.
• People with a specific muscle enzyme (CPK) blood level below a certain threshold (confirm with trial site).
• People who are able to have a CT scan with contrast dye.
• People who are able to swallow and keep down oral medications.
• Women who could become pregnant must have a negative pregnancy blood test before joining.
• Women who could become pregnant, and men whose partners could become pregnant, must agree to use highly effective contraception throughout the trial and for 180 days after the last dose of study treatment.
• People who are able to understand and sign an informed consent form, or who have a legally authorised representative who can do so on their behalf.

Who may not be able to join:

• People who have a second active cancer, unless it is in remission with a life expectancy of more than 2 years and the trial sponsor has given documented approval.
• People who have another active cancer (other than CLL) that requires systemic treatment (exceptions may be considered after discussion with the trial sponsor).
• People whose CLL has specific high-risk genetic features, specifically TP53 mutations and 17p deletion.
• People with a history of a severe muscle breakdown condition (grade 3 or higher rhabdomyolysis) who have not fully recovered.
• People who have previously received a type of immune cell therapy called CAR-T cell therapy.
• People who have taken an experimental drug or participated in a clinical trial within 28 days (or 5 half-lives, whichever is shorter) before starting the trial; or who have had a stem cell transplant from a donor within 60 days before starting; or who have significant graft-versus-host disease that still requires increasing levels of immune-suppressing medication.
• People who have received any other systemic cancer treatment (such as chemotherapy or immunotherapy) within 21 days or 5 half-lives before starting the trial — not including zanubrutinib, which may be continued until the day before the trial starts.
• People who have taken certain medications within 7 days or 5 half-lives before starting the trial, including: medications considered high-risk for causing a specific heart rhythm problem (prolonged QTc or Torsades de Pointes); a white blood cell growth injection called peg-filgrastim or equivalent; or the herbal supplement St John's Wort.
• People with a history of, or current, lung inflammation caused by a medication (drug-induced pneumonitis).
• People who have had a stroke or bleeding in the brain within the 6 months before starting the trial (small post-biopsy changes under 3mm may not be excluded — confirm with trial site).
• People who require blood-thinning medications such as warfarin or similar drugs, or dual antiplatelet agents, within a specific washout period before starting the trial; low molecular weight heparin is permitted, and use of other antiplatelet agents requires discussion with the trial sponsor.
• People who have received a live vaccine within 4 weeks before starting the trial.
• People with a known history of severe allergic reaction (including anaphylaxis) to either of the trial drugs (emavusertib or zanubrutinib) or any of their ingredients.
• People with a history of severe skin reactions called Stevens-Johnson syndrome or toxic epidermal necrolysis.
• People who are unable to have a contrast CT scan due to an allergy to contrast dye.
• People who have had major surgery within 28 days, or minor surgery within 7 days, before starting the trial.
• People who are HIV positive or have AIDS (though cases where the virus is undetectable or well-controlled on treatment may be considered after discussion with the trial sponsor).
• People with active hepatitis B or C virus infection within 6 months before starting the trial, unless the viral load is undetectable — or hepatitis C with liver scarring (cirrhosis).
• People with an active serious infection, including HIV, cytomegalovirus, COVID-19, or any infection (other than a nail fungal infection) that required hospitalisation or intravenous antibiotics within 28 days before starting the trial.
• People with another illness that would make safe participation in the study impossible.
• People who are pregnant or breastfeeding.

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