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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Acute myeloid leukaemia
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Background and study aims
Acute myeloid leukaemia (AML) is an aggressive blood cancer affecting 3000+ people per year in the UK. Patients who are relatively young and healthy are given potentially curative treatment with intensive chemotherapy (IC) which is fairly effective in inducing remission, and for some patients, long-term cure. IC has severe short-term side effects including decreasing white blood cell count (which can lead to potentially fatal infections), mouth ulcers, nausea, vomiting and hair loss. Long-term side effects include infertility, heart failure and secondary cancers.
Side effects are often more severe in older patients who have pre-existing medical conditions; therefore these patients are given treatments to control (rather than cure) the disease; less than half of these patients survive for over 1 year.
A new treatment (venetoclax) has been tested on patients with AML who were not suitable for IC, and the results have been extremely positive. Patients with a specific type of AML (called NPM1 mutated) had a particularly good response, with over 90% achieving a remission and over 75% alive after 2 years. This result seems as good as, if not better than results achieved with IC. Therefore, we would like to compare venetoclax to IC to see if the outcomes really are comparable.
We will initially test this in patients aged 55+ who are healthy enough to receive IC. We may subsequently lower the age limit if venetoclax is showing to be as good as IC. We will monitor patients throughout treatment and those who are not responding well can switch treatments or receive a stem cell transplant.
If successful, venetoclax treatment may replace IC, which would greatly benefit patient’s quality of life both during and after therapy. This study will be open at selected hospitals in the UK, Denmark and New Zealand and will be open for 2 years.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36376888/ (added 23/11/2022)
You can take part if:
Current inclusion criteria as of 09/02/2024:
1. Diagnosis of CD33-positive acute myeloid leukaemia
2. Age >=55 years (prior to the interim analyses performed after enrolment of 50 and 100 patients)
3. Genotype NPM1mut FLT3 ITDneg (FLT3- Tyrosine Kinase Domain mutation, TKD, is permitted)
4. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2
5. Serum creatinine <=1.5 x ULN (upper limit of normal)
6. Serum Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) <=2.5 ULN and bilirubin <=2 x ULN
7. Able to provide written informed consent
8. Considered fit for intensive chemotherapy with anthracyclines
You may not be able to take part if:
1. Previous chemotherapy for AML or any antedecent haematological condition, with the exception of hydroxycarbamide to control white blood cell count2. Other active malignancy requiring treatment3. Newly diagnosed or uncontrolled HIV or hepatitis B or C infection. Patients with known chronic infections may enrol if the last two tests for viral load have been negative and their current therapy does not include a protease inhibitor or a non-nucleoside reverse-transcriptase inhibitor4. Pregnant and lactating patients (patients of childbearing potential must have a negative pregnancy test prior to study entry)5. Females of childbearing potential, and their partners, not willing to use adequate contraception during and for up to 6 months after treatment6. Unable to swallow tablets whole7. Known hypersensitivity to any of the IMPs8. Patients known to require vaccination with a live vaccine during the treatment period
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Ms
Catherine
Thomas
+44 (0)121 371 7861
victor@trials.bham.ac.uk
The study is sponsored by University of Birmingham and funded by Cancer Research UK; Grant Codes: C65869/A29806.
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