Venetoclax or Intensive Chemotherapy for Treatment Of Favourable Risk Acute Myeloid Leukaemia: A Molecularly Guided Phase 2 Study

Study ID: 46867
Short Title: VICTOR
Trust Name: SFT,UHS
Recruitment Site: Salisbury District Hospital,Southampton General Hospital
Disease Area: Haematology
Phase: II
Expected End Date: 01/06/2024
Postcode: SP2 8BJ
SO16 6YD
Contact Name: Amanda Pattie
Contact Email: studysupport1and3.crnwessex@nihr.ac.uk
Active: Yes

Inclusion criteria, exclusion criteria and study summary

• Diagnosis of CD33 positive Acute Myeloid Leukaemia • Age > = 60 years (prior to the interim analyses performed after enrolment of 50 and 100 patients) • Genotype NPM1mut FLT3 ITDneg (FLT3- Tyrosine Kinase Domain mutation, TKD, is permitted) • Eastern Cooperative Oncology Group (ECOG) performance status 0-2 • Serum creatinine < = 1.5 x ULN (upper limit of normal) • Serum Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) < = 2.5 ULN and bilirubin < = 2 x ULN • Able to provide written informed consent • Considered fit for intensive chemotherapy with anthracyclines by treating physician

• Previous chemotherapy for AML or any antedecent haematological condition, with the exception of hydroxycarbamide to control white blood cell count • Other active malignancy requiring treatment • 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 inhibitor • Pregnant and lactating patients (patients of childbearing potential must have a negative pregnancy test prior to study entry) • Females of childbearing potential, and their partners, not willing to use adequate contraception during and for up to 6 months after treatment • Unable to swallow tablets whole • Known hypersensitivity to any of the IMPs • Patients known to require vaccination with a live vaccine during the treatment period

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.

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