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 must be at least 18 years old and willing to sign a consent form before taking part.
• You have been diagnosed with one of the following blood/bone marrow conditions, confirmed by laboratory testing under the 2016 WHO classification system: Chronic Myelomonocytic Leukemia (CMML) at intermediate-2 or high risk; Atypical Chronic Myelocytic Leukemia (aCML); MDS/MPN unclassified; Myeloproliferative Neoplasm in accelerated phase (MPN-AP); or MDS/MPN with ring sideroblasts and high platelets (confirm specific disease type with trial site).
• For the early phase of the trial (Phase 1b), your condition must have come back or stopped responding to previous treatment; for the later phase (Phase 2), you must be newly diagnosed.
• If you have MPN in accelerated phase, you must have previously had a related blood condition (polycythemia vera, essential thrombocythemia, or primary myelofibrosis) at intermediate-2 or high risk, and at least one previous treatment must not have worked.
• Your doctor has decided that strong/intensive chemotherapy is not suitable for you right now, based on your age, other health conditions, or local medical guidelines.
• You are generally well enough to carry out daily activities (your fitness level meets a standard scale score of 0, 1, or 2 — confirm with trial site).
• Your liver function test results are within an acceptable range (no more than 3 times the normal upper limit for certain liver enzymes).
• Your bilirubin level (a substance measured in blood) is within an acceptable range (no more than 1.5 times the normal upper limit, with an exception for a condition called Gilbert syndrome).
• Your kidneys are working well enough, based on a standard blood test measuring kidney filtration rate (at least 30 mL/min/1.73m²).
• You are able to communicate with the medical team and follow the study procedures as required.
• Women who could become pregnant and men who have not had surgical sterilisation must use effective contraception starting 14 days before joining the trial and continuing until 90 days after the final follow-up visit.

Who may not be able to join:

• You have previously received certain treatments for your blood condition, including most chemotherapy, lenalidomide, or drugs called hypomethylating agents (such as azacitidine or decitabine) — however, if you had 2 cycles or fewer of these drugs, you may still be eligible; previous treatment with hydroxyurea or ruxolitinib is allowed.
• You have been diagnosed with Acute Myeloid Leukemia (AML) or a related condition.
• Your doctor considers you suitable for intensive chemotherapy, or you are unwilling to consent to that type of treatment being offered.
• You have previously had an organ transplant or a stem cell transplant from another person.
• You have a history of another cancer, unless it has been fully treated and requires no ongoing cancer treatment during the trial — people on hormone therapy for another cancer may still be eligible, but not those whose current cancer was caused by a previous cancer treatment (confirm with trial site).
• You have a known allergy or sensitivity to the study drug, axatilimab.
• You have a history of pancreatitis (inflammation of the pancreas), either short-term or long-term.
• You have a history of myositis (inflammation of the muscles).

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