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:

• You have been diagnosed with MDS (myelodysplastic syndrome) at intermediate, high, or very high risk, and have had no previous treatment or up to 2 prior treatments (Arm 1); OR you have AML (acute myeloid leukemia) that has come back or stopped responding to treatment, and are on your 1st or 2nd attempt at further treatment (Arm 2).
• You are 18 years of age or older.
• You are reasonably able to carry out daily activities — not severely limited by your illness (confirm with trial site).
• Any side effects from previous treatments have mostly cleared up, with only mild issues remaining (hair loss or mild nerve-related symptoms may still be acceptable).
• Your kidneys are working well enough, based on a blood or urine test (confirm with trial site).
• Your liver function results are within acceptable ranges based on blood tests (confirm with trial site).
• Your white blood cell count is below a certain level (medication can be used to bring it down if needed).
• You are able to understand the study information and sign a consent form.
• If you are a woman who could become pregnant, you have had a negative pregnancy test within 72 hours before starting treatment.
• You agree to use effective contraception during the study — women for at least 4 months after the last treatment, and men for at least 3 months after the last treatment.

Who may not be able to join:

• You have another serious, uncontrolled medical condition such as uncontrolled diabetes, heart disease, kidney disease, high blood pressure, or an active uncontrolled infection.
• You are currently receiving cancer treatment (chemotherapy or radiation) for a different cancer (some maintenance or hormonal therapies may still be allowed — confirm with trial site).
• You have had an organ transplant or bone marrow/stem cell transplant within the last 3 months, or you have active moderate-to-severe graft versus host disease, or you require strong transplant-related immune-suppressing medications.
• You have leukemia that has spread to your brain or spinal fluid and is causing symptoms or is poorly controlled.
• You have HIV that is not well controlled (meaning the virus is still detectable in your blood).
• You have active hepatitis B or C with detectable virus levels in your blood.
• You have had a major surgical procedure within 14 days before starting the trial.
• You have other serious active medical or mental health conditions — including active suicidal thoughts or behaviour, active colitis, or inflammatory bowel disease — that the trial doctor feels would make participation unsafe.
• You have an active, uncontrolled infection requiring treatment, uncontrolled high blood pressure, severe uncontrolled heart failure, or a significant uncontrolled heart rhythm problem.
• You currently need to take certain medications that suppress the immune system known as anti-TNF drugs (such as infliximab, etanercept, adalimumab, certolizumab, or golimumab).
• You are unwilling or unable to follow the trial's requirements.
• You have received a live vaccine within 28 days before starting the trial.

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