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:

• People who are willing and able to sign a consent form before any study procedures begin
• People diagnosed with MDS, CMML, or secondary AML (a type of blood cancer that developed from another blood condition) according to standard medical classification, with certain high-risk features in their bone marrow or genetic test results
• People who have either received no prior treatment, or have only been treated with oral Hydroxyurea, or have had no more than 2 courses of Azacytidine or Decitabine (with or without Venetoclax)
• People for whom a well-matched stem cell donor (related or unrelated) has been identified
• People aged 18 or older
• People whose overall health score (a measure of how well the body can tolerate treatment, called HCT-CI) is 3 or below — with an exception allowed for a previous history of a solid tumour
• People with a general physical fitness score (called ECOG) of 2 or below at the time of joining the study
• People who do not have an active, uncontrolled infection at the time of joining
• People who are able to attend scheduled study visits and follow study requirements
• Women who could become pregnant must: understand the potential risks of Venetoclax to an unborn baby; agree to pregnancy testing before and at the start of treatment; avoid becoming pregnant during treatment and for at least 1 month after the last dose; use effective contraception (and add a barrier method if using hormonal contraception, as it is currently unknown whether Venetoclax may reduce its effectiveness); and notify their study doctor immediately if there is any risk of pregnancy
• Men must agree to use condoms from the first day of the study until at least 30 days after the last dose (even following a vasectomy), and must notify the study doctor immediately if their partner becomes pregnant or receives a positive pregnancy test during the study

Who may not be able to join:

• People with secondary AML that has a specific gene change called an FLT3 mutation
• People whose bone marrow contains more than 30% blast cells (abnormal blood cells) at the time of screening
• People whose white blood cell count remains above 20,000 per microlitre despite treatment with Hydroxyurea
• People who have had more extensive prior treatment than oral Hydroxyurea or more than 2 courses of Azacytidine, Decitabine, or low-dose Ara-C (with or without Venetoclax)
• People who have previously had an allogeneic blood stem cell transplant (a transplant using donor stem cells)
• People whose MDS, CMML, or secondary AML has spread to the central nervous system (brain and spinal cord) and is causing symptoms
• People with a serious medical condition, significant abnormal test results, or a mental health condition that would prevent them from signing the consent form or safely participating
• Women who are pregnant or breastfeeding
• People who are unwilling to use safe contraception during the study
• People with a significant heart condition, specifically heart failure above a moderate level, a heart pumping function below 40%, or chronic stable chest pain (angina)
• People with significantly reduced lung function on specific breathing tests (confirm with trial site for exact thresholds)
• People with significantly reduced kidney function (confirm with trial site for exact thresholds)
• People with significantly reduced liver function based on blood test results (confirm with trial site for exact thresholds)
• People with a known allergy or severe reaction to any of the study drugs: Venetoclax, Fludarabine, Amsacrine, Ara-C, or Treosulfan
• People currently receiving other cancer treatments (other than Hydroxyurea or up to 2 courses of Azacytidine or Decitabine)
• People who test positive for HIV or have active hepatitis A, B, C, or E infection
• People with a history of another cancer (other than MDS, CMML, or secondary AML), unless they have been cancer-free for 2 or more years — with exceptions for certain minor skin cancers or early-stage cervical or breast cancer
• People who have taken part in another clinical trial using an unlicensed experimental treatment within 28 days (or within 5 half-lives of that treatment) before joining this study
• People who have used steroid therapy for cancer treatment, or certain medications that strongly affect how the body processes drugs (called CYP3A inhibitors or inducers), within 7 days before starting the study drug
• People who are unwilling to avoid grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges), or star fruit for 3 days before starting the study drug
• People who have a close personal or professional dependency on the study investigator, or who are employed by the trial sponsor or investigator
• People who are being held in an institution under a legal or official order

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