Trial purpose
Cancer treatment
Tumor type
Haematological
Age
18+
Trial acronym
DIAAMOND-Ava FIRST
Clinical summary
Summary
Eligible patients will receive oral Avatrombopag at a maximum dose of 60 mg per day for up to 180 days. The Avatrombopag dose will be adjusted every 2 weeks guided by reticulocyte count, platelet count/platelet transfusion and neutrophil count.
Conditions
This trial is treating people with severe aplastic anaemia
Eligibility
Inclusion
1. Severe or very severe aplastic anaemia characterised by bone marrow cellularity <30% (excluding lymphocytes) and at least two of the following:
a. Absolute neutrophil count <0.5 x10^9/L
b. Platelet count <20 x 10^9/L
c. Absolute reticulocyte count <60 x 10^9/L
2. No prior ATG-based immunosuppressive therapy
3. Age >18 years
4. Negative pregnancy test for women of child bearing potential
Exclusion
1. Planned for a sibling allogeneic stem cell transplant
2. Evidence of a myelodysplastic syndrome, defined according to the World Health Organization 2017 criteria. Patients with AA with cytogenetic abnormalities that are recurrent in MDS, who do not meet the WHO diagnostic criteria for MDS, are also excluded. Patients with del(20q), +8 and –Y are not included in this category and are therefore eligible for this trial.
3. Known diagnosis or clinical suspicion of inherited bone marrow failure syndrome (IBMFS), including but not limited to Fanconi Anaemia, Dyskeratosis Congenita, Shwachman-Diamond Syndrome and Diamond-Blackfan Anaemia
4. Previous history of stem cell transplantation
5. Cancer diagnosis within the last 5 years (except for patients with resected basal cell carcinoma or squamous cell carcinoma of the skin)
6. Previous history of melanoma
7. Pregnant or breast feeding patients2,3
8. Active CMV disease
9. Participants with known hypersensitivity to any of the component medications (avatrombopag, cyclosporine, horse or rabbit ATG)
10. Concurrent hepatic, renal or cardiac disease of such severity that it would in the investigator’s opinion, preclude the patient’s ability to tolerate protocol therapy
11. Death anticipated within 14 days
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ANZCTR *. View further details about this trial on the registry via the links below:
Trial sponsor
Monash University
Scientific Title
Avatrombopag plus up Front ImmunosuppReSsive Therapy in treatment-naive severe aplastic anaemia (AA) - a Bayesian Optimal Phase II study
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