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 who have chronic lymphocytic leukaemia (CLL) that has come back or stopped responding to treatment, and whose condition meets recognised criteria for needing further treatment.
• People whose CLL is measurable, meaning it can be detected through blood counts, bone marrow involvement, an enlarged spleen, or enlarged lymph nodes of a certain size.
• People who have already received at least two previous treatments for CLL, including at least one treatment from a specific class of drugs called covalent BTK inhibitors.
• People who are willing to have bone marrow biopsies before and during treatment.
• People aged 18 or older at the time of signing the consent form.
• People with a general health and activity level rated as reasonably functional (scored 0, 1, or 2 on a standard medical scale called the ECOG scale).
• People whose blood counts and organ function — including platelets, liver function, and kidney function — meet the minimum levels required by the trial (confirm specific values with trial site).
• People with central nervous system (CNS) disease that is inactive, has been treated and is no longer causing symptoms, or is being managed with steroids or anti-seizure medication (confirm with trial site).
• People willing to use reliable contraception before and throughout the trial, and for a specified period after treatment ends.
• People who are able to understand and sign a written consent form agreeing to follow the trial requirements.
• People who are able to receive infection prevention treatments and supportive care according to their institution's guidelines.

Who may not be able to join:

• People who have received venetoclax or a type of drug called a PI3K inhibitor within the past 6 months, or who have had any CLL treatment within a period determined by the half-life of that treatment before the trial starts.
• People who have received a live vaccine within 30 days before the planned start of treatment.
• People who are currently taking high-dose immune-suppressing medications or steroids above a certain daily dose to manage conditions such as autoimmune blood disorders.
• People who have a history of CLL transforming into a more aggressive type of lymphoma or leukaemia.
• People who still have significant side effects (above a minor level) from previous cancer treatments, except for hair loss or tiredness. Any serious side effects from prior immunotherapy must have fully resolved at least two weeks before the trial begins.
• People who are currently taking part in another clinical trial for CLL or a related condition.
• People with a history of serious allergic reactions to drugs similar in composition to the trial medicines, unless that reaction occurred more than 6 months before starting the study.
• People with a history of a systemic autoimmune disease.
• People currently taking certain medications that strongly affect how the body processes the drug venetoclax (known as strong CYP3A inhibitors or inducers), as these can interfere with the trial treatment in ways that may be unsafe (confirm specific medications with trial site).
• People who are pregnant or breastfeeding, as the trial drugs may cause harm to unborn babies or infants.
• People with a history of another cancer who currently need treatment for that cancer in a way that would interfere with this trial, unless that cancer was treated with curative intent and has shown no sign of returning for at least 2 years, or falls into specific categories of low-risk or adequately treated cancers (confirm with trial site).
• People who cannot swallow tablets or who have a condition affecting the upper digestive tract that would prevent taking oral medications.
• People with a history or current presence of heart or cardiovascular disease that the trial investigator considers may affect participation, or whose heart electrical reading (QTcF) is above a certain level at screening.
• People who have received treatment for tuberculosis within the past two years.
• People who have an active, ongoing bacterial, fungal, or viral infection — including hepatitis — that currently requires intravenous treatment at the time the trial would begin.
• People living with HIV who are being treated with medications that may interact with venetoclax or increase the risk of certain side effects.
• People with any serious or uncontrolled medical condition or active infection that, in the trial investigator's opinion, would increase the risks of participating or prevent the person from completing the treatment.
• People with a known history of alcohol or substance misuse.

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