MYDAS-T
Advancing treatment therapies in Myelodysplasia
Myelodysplasia
Traditionally, combination therapy has not proven to be effective in Myelodysplasia (MDS) given the increased toxicity of drugs used in combination with standard therapies. The aim of this master platform trial is to test a range of novel treatments aimed at targeting MDS to find safe and effective drug combinations.
You may be eligible to participate in this study if you are aged 16 or older (depending on the study, this may be limited to 18 and older) and you have a diagnosis of either MDS or acute myeloid leukemia (AML) with less than 30% blasts.
If you choose to enrol in this trial you will undergo a screening process where blood and bone marrow samples are taken prior to starting any treatments. The study doctors will assess your samples for specific MDS markers and will then prescribe a combination treatment that may be effective. Participants who do not respond to treatment or whose disease worsens may be removed from treatment and be reassessed for the next best treatment option to receive. During treatment participants will be assessed regularly which will include physical exams, blood tests, ECG (heart monitoring), bone marrow biopsies, toxicities to the treatment, quality of life. After treatment, disease will continue to be monitored and if participants have MDS progression or morphological relapse they will be assessed for the next best treatment option.
It is hoped that the results of this trial will help us to determine which drug combinations are safe (minimal side effects/toxicity) and effective for treating MDS.
Key inclusion criteria
1. Provision of written informed consent
2. Provision of written informed consent to the ALLG NBCR
3. Age 18+ (Age 16-17 permitted if consent for minor PICF approved by the authorising HREC)
4. A diagnosis of MDS or AML with less than 30% blasts
Key exclusion criteria
1. History of other malignancy requiring active systemic treatment, or which is likely to result in an expected survival time of less than 12 months.
2. Viral infection with known HIV or viral hepatitis type B or C not adequately controlled by antiviral medication
3. Prior bone marrow or stem cell transplantation for a diagnosis of Myelodysplasia or acute myeloid leukaemia. If stem cell transplantation has been undertaken for other reasons- refer to individual domain and discuss with study team.
2. Viral infection with known HIV or viral hepatitis type B or C not adequately controlled by antiviral medication
3. Prior bone marrow or stem cell transplantation for a diagnosis of Myelodysplasia or acute myeloid leukaemia. If stem cell transplantation has been undertaken for other reasons- refer to individual domain and discuss with study team.
Australasian Leukaemia & Lymphoma Group
MDS05
ACTRN12622000410752