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Latest ALLG clinical trials recruiting for AML

Four clinical trials run by the Australasian Leukaemia & Lymphoma Group* (ALLG) are currently open to a range of people with acute myeloid leukaemia (AML) across Australia.

Professor Andrew Wei
Professor Andrew Wei

AMLM21 – leading doctor, Professor Andrew Wei

The AMLM21 study is evaluating ponatinib (Iclusig®) in combination with 5-azacytidine (Vidaza®) in FLT3-ITD or CBL positive patients with AML who have failed prior therapy or are unfit for intense chemotherapy.

The trial is open to recruitment at the following sites:
Victoria – Alfred Hospital, Barwon Health
New South Wales – Liverpool Hospital, Calvary Mater Newcastle, Westmead Hospital
Queensland – Royal Brisbane Hospital.

AMLM22 – leading doctor, Professor Andrew Wei

The most appropriate treatments for AML patients in their maintenance treatment phase are being evaluated in the AMLM22 platform trial.

This randomised, multi-arm study platform is comparing the efficacy of experimental therapies versus standard of care in patients with AML who are in first complete remission. The AMLM22 trial is an adaptive trial platform designed to compare the efficacy of novel therapies or combinations flexibly and efficiently to the current standard of care. Several treatment domains are proposed on the platform with patients randomised to the domain they are eligible to participate in, and then randomised to either an investigational or standard of care treatment arm.

This trial is open to recruitment at the following sites:
Victoria – Alfred Hospital, Peter MacCallum Cancer Centre, Royal Melbourne Hospital, Austin Health, Barwon Health, Monash Health
New South Wales – Calvary Mater Newcastle, Border Medical Oncology, Prince of Wales Hospital, Concord Hospital, Gosford Hospital, Royal North Shore Hospital, Orange Health Service, Wollongong Hospital
Queensland – Princess Alexandra Hospital, Townsville Hospital, ICON integrated Cancer Centre
South Australia – Royal Adelaide Hospital
Tasmania – Royal Hobart Hospital, Launceston Hospital
Western Australia – Fiona Stanley Hospital, Sir Charles Gairdner Hospital, Royal Perth Hospital
Northern Territory – Royal Darwin Hospital.

Professor Paula Marlton
Professor Paula Marlton

AMLM23 – leading doctor, Professor Paula Marlton

The HO150/AMLM23 trial is an international trial led by the Heamato Oncology Foundation for Adults in the Netherlands (HOVON).

This placebo-controlled study compares ivosidenib (Tibsovo®) or enasidenib (Idhifa®) in patients newly diagnosed with AML or myelodysplastic syndrome (MDS). The purpose of the study is to investigate the efficacy and safety of ivosidenib and enasidenib in patients with AML or MDS.

This trial is open to recruitment at the following sites:
Victoria – Royal Melbourne Hospital, St Vincent’s Hospital, Alfred Hospital
New South Wales – Royal Prince Alfred Hospital, Concord Hospital
Queensland – Princess Alexandra Hospital, Townsville Hospital
Tasmania – Royal Hobart Hospital
Western Australia – Fiona Stanley Hospital.

AMLM25 – leading doctor, Professor Andrew Wei

The AMLM25 trial is a Phase II trial evaluating the most appropriate treatments for older AML patients.

AMLM25, also known as the INTERVENE study, is aimed at improving treatment for people aged 60 or older with adverse risk and non-adverse risk AML who have not already received previous chemotherapy (treatment-naïve), or those who are not able to receive intensive initial chemotherapy. It is hoped that the treatment will improve the initial response, prolong the duration of response, and increase overall survival.

The aim of the first part of the study is to determine the safest dose of the study drugs midostaurin (Rydapt®) or pracinostat when given in combination with venetoclax (Venclexta®) and cytarabine (LDAC).

The second part of the study will compare the effectiveness and safety of midostaurin and pracinostat when used in combination with venetoclax and cytarabine.

This trial is open to recruitment at the following sites:
Victoria – Alfred Hospital, Peter MacCallum Cancer Centre, Royal Melbourne Hospital, St Vincent’s Hospital, University Hospital Geelong
New South Wales – Calvary Mater Newcastle
Tasmania – Royal Hobart Hospital
Queensland – Townsville Hospital, Princess Alexandra Hospital
South Australia – Royal Adelaide Hospital, Flinders Medical Centre
Western Australia – Fiona Stanley Hospital.

For more information on current clinical trials in AML, visit the ALLG website, or speak to your treating haematologist.

* The ALLG is the only not-for-profit collaborative clinical trial group in Australia and New Zealand delivering research projects focused on blood cancers. The ALLG’s purpose is to achieve better treatments and better lives for people with AML and other blood cancers. ALLG clinical trials are taking place at 93 accredited hospital sites and cancer centres across the the country and more than 800 physicians and haematologists, nurses, scientists, and professional support staff are ALLG members.