Phase 3 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:

For the monotherapy parts of the trial (Phase 2 and Phase 3 — for people with MDS, CMML, or related blood disorders):

• People with a confirmed diagnosis of MDS (myelodysplastic syndrome), CMML (chronic myelomonocytic leukemia), or a related blood disorder, where a doctor has determined that treatment with azacitidine alone is appropriate based on local medical guidelines.
• People whose MDS or CMML falls into specific subtypes — including refractory anemia, refractory anemia with ringed sideroblasts (with certain complications), refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, CMML, or intermediate-2 or high-risk MDS as scored by a standard medical rating system (Phase 3 only).
• People with a general health and activity level rated as 0 or 1 on a standard medical scale (meaning fully active or able to carry out light activity) (Phase 3 only).
• People whose kidneys, liver, and other organs are functioning at an adequate level (Phase 3 only).
• People who have previously had a stem cell transplant from a donor, provided there is no sign of a complication called graft-versus-host disease (Phase 3 only).
• People who have not had major surgery in the 3 weeks before starting the trial (Phase 3 only).
• People who have not received certain cancer-killing chemotherapy (not including a drug called hydroxyurea) in the 4 weeks before starting the trial (Phase 3 only).
• People who are able to swallow the required number of tablets or capsules within 10 minutes and can go without food for 4 hours (Phase 3 only).
• People with a life expectancy of at least 12 weeks.

For the combination therapy parts of the trial (Phase 1 and Phase 2 — for people with newly diagnosed AML):

• People with a newly confirmed diagnosis of AML (acute myeloid leukemia), verified by standard diagnostic criteria.
• People with a life expectancy of at least 12 weeks.
• People who a doctor has determined are not suitable for intensive chemotherapy, either because they are aged 75 or older, or because they are aged 18 to 74 with at least one of the following health conditions: a serious heart condition, a serious lung condition, reduced kidney function (creatinine clearance between 30 and less than 45 mL/min), moderate liver impairment, or a general health rating of 2 or 3 on a standard medical scale (confirm with trial site).
• People aged 75 or older with a general health rating of 0 to 2, or people aged 18 to 74 with a rating of 0 to 3, on a standard medical activity scale.

Who may not be able to join:

For the monotherapy parts of the trial:

• People with an active, uncontrolled stomach or small intestine ulcer.
• People with other serious medical conditions that pose significant health risks.
• People with a known HIV infection.
• People known to have an active Hepatitis B or Hepatitis C infection.
• People with a life-threatening illness (other than the condition being studied).
• People with a history of another cancer before joining the trial, unless it was an early-stage or localised cancer that was fully treated and resolved — certain skin cancers, early breast or cervical cancers, or other cancers that required no ongoing treatment may be acceptable (confirm with trial site).
• People with MDS/MPN or CMML who have disease that has spread outside the bone marrow, such as a noticeably enlarged liver or spleen that a doctor can detect on examination.
• People who have already received more than one cycle of certain similar treatments, including decitabine, azacitidine, or guadecitabine (Phase 2 and Phase 3 only).
• People who have taken an experimental drug or therapy within the past 2 weeks (or within 5 half-lives of that drug, whichever period is longer), or who are still experiencing significant side effects from a previous experimental treatment.
• People with a known or suspected allergic reaction to cedazuridine, azacitidine, or any ingredients in those medications.
• People who are unable to stop taking medications that slow stomach emptying — such as certain diabetes or weight-loss injections (GLP-1 or GIP agonists) — during the first two cycles of the trial.

For the combination therapy parts of the trial:

• People with a history of certain blood or bone marrow disorders, including myelofibrosis, essential thrombocythemia, polycythemia vera, or chronic myeloid leukemia, or a specific type of AML linked to the BCR-ABL1 gene change.
• People whose AML has specific chromosomal abnormalities — particularly a type called acute promyelocytic leukemia that responds to a specific treatment called ATRA; also, certain other chromosomal changes are excluded in Phase 2 (confirm with trial site).
• People whose AML has spread to the brain or spinal cord.
• People with a known HIV infection.
• People known to have an active Hepatitis B or Hepatitis C infection.
• People with severe liver impairment.
• People with severe kidney impairment.
• People with a condition that prevents them from absorbing medications taken by mouth.
• People with a heart condition rated as Class 3 or higher on a standard heart health scale (meaning significant limitation of physical activity due to heart symptoms).
• People with a significant history of serious kidney, nerve, psychiatric, hormonal, immune, liver, heart, or lung disease, or any other medical condition the trial doctor believes would make participation unsafe.
• People with a serious, uncontrolled infection (viral, bacterial, or fungal) at the time of joining.
• People with a history of another cancer before joining the trial, with similar exceptions as noted in the monotherapy section above (confirm with trial site).
• People with a very high white blood cell count (above 25,000 per microlitre) — though a drug called hydroxyurea may be used to bring this count down beforehand (confirm with trial site).
• People who have previously been treated with certain medications including azacitidine, decitabine, venetoclax, CAR-T cell therapy, or any experimental therapy for MDS or AML.
• People who are unable to stop taking certain antifungal or other medications that interact with the trial drugs in specific ways, within the required time before starting treatment (confirm with trial site).
• People who cannot avoid certain medications known to interfere with how the trial drugs are processed in the body (confirm with trial site).
• People who cannot stop taking medications that slow stomach emptying, such as certain diabetes or weight-loss injections, during the first two cycles of the trial.
• People who are currently taking part in another research study that involves drug treatment or medical procedures.
• People with a known or suspected allergic reaction to cedazuridine, azacitidine, venetoclax, or any ingredients in those medications.
• People with a known significant mental health condition, or a current issue with alcohol or substance use.
• People who have consumed grapefruit, grapefruit products, Seville oranges (including marmalade made with Seville oranges), or starfruit within 7 days before starting treatment.

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