VICTOR
Research type
Research Study
Full title
Venetoclax or Intensive Chemotherapy for Treatment Of Favourable Risk Acute Myeloid Leukaemia: A Molecularly Guided Phase 2 Study
IRAS ID
277635
Contact name
Richard Dillon
Contact email
Sponsor organisation
University of Birmingham
Eudract number
2020-000273-24
ISRCTN Number
ISRCTN15567173
Duration of Study in the UK
5 years, 5 months, 31 days
Research summary
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 one 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 60+ 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.
REC name
London - London Bridge Research Ethics Committee
REC reference
20/LO/1056
Date of REC Opinion
28 Sep 2020
REC opinion
Favourable Opinion