Phase 3 Leukaemia Trial, Completed

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 able to understand and sign a consent form agreeing to take part in the study.
• People who are 18 years old or older at the time of signing the consent form.
• People who are able to attend all required study visits and follow the study rules.
• People who have an official diagnosis of a type of blood cancer called B-cell chronic lymphocytic leukaemia (CLL).
• People who have previously been treated with at least one specific type of CLL treatment in their first or second round of treatment (such as certain chemotherapy drugs, targeted antibody therapies, or a drug called alemtuzumab for those with a specific genetic change called 17p deletion — confirm specific treatment history with trial site).
• People whose CLL responded at least partially to their second round of treatment, with documentation of that response available.
• People who finished their last cycle of second-round treatment no less than 8 weeks and no more than 20 weeks before joining the trial.
• People with a general health and activity level score (called ECOG status) of 2 or lower, meaning they are able to care for themselves even if they cannot do all physical activities (confirm with trial site).
• Women who could become pregnant must have two negative pregnancy tests before starting the study, agree to ongoing pregnancy testing throughout and after the study, and either remain completely abstinent from heterosexual contact or use effective contraception continuously from 28 days before starting the study drug until 28 days after finishing it.
• Male participants must either remain completely abstinent from heterosexual contact or use a condom during any sexual contact with a woman who could become pregnant — even after a vasectomy — throughout the study and after finishing the study drug, and must agree not to donate sperm during or after the study drug period.
• All participants must acknowledge that the study drug carries a potential risk of causing harm to an unborn baby, agree not to donate blood while taking the study drug and after stopping it, agree not to share the study medication with anyone else, and must receive counselling about pregnancy risks.

Who may not be able to join:

• People with a serious medical condition, significant abnormal test results, or a psychiatric illness that would make it unsafe or impossible to participate.
• People who currently have an active infection that requires antibiotic treatment taken throughout the body (not just topically).
• People who have had a persistent widespread infection that has not cleared up more than 2 months before the planned start of the study drug, despite appropriate treatment.
• People who received a bone marrow or stem cell transplant (either from their own cells or from a donor) as their second round of CLL treatment.
• People who are pregnant or currently breastfeeding.
• People who received any CLL treatment in the time between finishing their second round of treatment and joining the trial.
• People who have taken part in another clinical trial or taken an experimental treatment for a condition other than CLL within 28 days before starting the study.
• People with a known history of alcohol or drug misuse.
• People whose CLL has spread to the central nervous system (brain or spinal fluid), or who have signs or a history suggesting this (confirm with trial site regarding required testing before joining).
• People who have had a different cancer in the past, unless they have been cancer-free for 5 years or more — though certain minor skin cancers, early-stage cervical or breast changes, or a very early incidental finding of prostate cancer may be exceptions (confirm with trial site).
• People who have a history of kidney failure that required dialysis.
• People with a known HIV infection, or an active hepatitis B or hepatitis C infection.
• People who have previously been treated with a drug called lenalidomide.
• People who show signs of a condition called tumour lysis syndrome (a dangerous imbalance in blood chemistry) — though participation may be considered once those abnormalities are corrected (confirm with trial site).
• People whose blood test results show kidney function below a certain level, too few white blood cells (neutrophils) or platelets, liver enzyme levels that are too high, or bilirubin levels that are too high (specific thresholds must be confirmed with the trial site; an exception may apply for a condition called Gilbert's Syndrome).
• People who experienced a severe (Grade 4) skin rash from a previous treatment with a drug called thalidomide.
• People with an uncontrolled overactive or underactive thyroid.
• People who have had a blood clot in a vein within the past year.
• People with moderate or severe nerve damage (Grade 2 or higher neuropathy) (confirm with trial site).
• People with uncontrolled autoimmune destruction of red blood cells or platelets.
• People whose CLL has transformed into a more aggressive disease (such as Richter's Syndrome or prolymphocytic leukaemia).
• People who are allergic to a drug called allopurinol, if their CLL only partially responded to their second round of treatment.
• People who are currently imprisoned.
• People who have already received more than two rounds of CLL treatment.

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