Phase 1 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:

• People aged 18 or older.
• People who have been diagnosed with a specific type of blood/bone marrow condition called proliferative CMML, atypical CML, or MDS/MPN-NOS, with a high white blood cell count at the time of diagnosis (confirm with trial site if white blood cell count was lowered by treatment before joining).
• People whose condition has come back or stopped responding to treatment with hydroxyurea or at least 4 cycles of a type of drug called a hypomethylating agent, or who were unable to tolerate either of these treatments.
• People who are well enough to carry out basic daily activities (a standard medical fitness measure rated 0, 1, or 2 out of 4).
• People who have mostly recovered from the side effects of any previous cancer treatment (minor lasting effects may be acceptable).
• People with a platelet count of at least 20,000 per mm³ within the past 14 days (in some cases, a lower count may be acceptable with a blood transfusion — confirm with trial site).
• People with liver function test results within acceptable ranges on blood tests taken within the past 14 days.
• People with kidneys functioning at an adequate level, measured within the past 14 days.
• People who are willing and able to give written informed consent before any study procedures begin.
• People who are able to travel back to the enrolling site for follow-up visits.
• People who are willing to provide bone marrow and blood samples for research purposes as required by the study.
• People who are able to complete questionnaires, either on their own or with assistance.
• People who are able and willing to use effective contraception (or who are not of childbearing potential) for the duration of the study and for 180 days after the last dose of study drug. Accepted methods include complete abstinence, hormonal contraception, an intrauterine device (IUD) with a failure rate below 1% per year, barrier methods combined with another method, or a partner who has been surgically sterilised.
• Women who could potentially become pregnant must have a negative pregnancy test within 7 days before joining the study.

Who may not be able to join:

• People who have previously been treated with another investigational PLK1 inhibitor drug (a specific type of experimental treatment).
• People whose condition has already progressed to acute leukaemia (a more advanced blood cancer).
• People who have had a bone marrow transplant and are currently experiencing moderate to severe graft-versus-host disease (a complication where transplanted cells attack the body), or who are still on immunosuppressive drugs for this condition.
• People with active cancer affecting the brain or spinal cord.
• People with another active cancer at the same time, with some exceptions (such as certain previously treated skin cancers or other cancers with no sign of return for more than 2 years — confirm with trial site).
• People with severe heart failure or active chest pain due to a heart condition.
• People who have received cancer treatment (other than hydroxyurea) within 2 weeks before joining.
• People currently taking part in another clinical trial for a treatment targeting their primary condition.
• People who have had major surgery within 6 weeks before joining.
• People with significant gut or digestive conditions that could affect how the study drug is absorbed into the body (such as severe Crohn's disease, ulcerative colitis, or major bowel surgery).
• People who are unable or unwilling to swallow the study medication.
• People with uncontrolled serious illness, including active infections, significant heart rhythm problems, significant breathing difficulties, poorly healing wounds, or mental health or social situations that would make it difficult to follow the study requirements.
• People with an active HIV infection with detectable virus levels, active hepatitis B infection, or active hepatitis C infection with detectable virus levels.
• People who have received a live vaccine (such as for chickenpox) within 28 days before joining. Note: mRNA-based COVID-19 vaccines (such as Pfizer or Moderna) and certain other COVID-19 vaccines are permitted.
• People who require regular high-dose steroid treatment (20 mg per day of prednisone or equivalent) for another condition.
• People taking certain strong medications that significantly affect how the body processes a specific liver enzyme pathway (CYP3A4) — confirm which medications are affected with the trial site.
• People with a specific heart electrical measurement (QTcF interval) above 470 milliseconds on an ECG (heart tracing).
• People at increased risk of a serious heart rhythm problem called Torsade de Pointes, including those with a QTc interval repeatedly above 480 milliseconds, a history of heart failure, or a family history of a condition called long QT syndrome.
• People who are pregnant or breastfeeding.
• People who are unwilling to use adequate contraception during and after the study.
• People whose bone marrow biopsy at the time of registration shows transformation to acute leukaemia.

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