Trial purpose
Cancer treatment
Tumor type
Haematological
Age
18+
Trial acronym
The DIAAMOND-Ava NEXT Trial
Clinical summary
Summary
Eligible patients will receive oral avatrombopag at a maximum dose of 60mg per day, for up to 180 days. 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 aplastic anaemia
Eligibility
Inclusion
1. Refractory severe aplastic anaemia with an incomplete response following at least one course of horse or rabbit ATG given greater than 6 months ago. Incomplete response defined as any one of the following:
o Absolute neutrophil count <0.5 x10^9/L
o Platelet count <20 x 10^9/L
o Absolute reticulocyte count <60 x 10^9/L or ongoing requirement for red cell transfusion support (if not due to independent medical condition)
OR
Relapsed severe aplastic anaemia, defined as the occurrence of any of the following, after a haematological response to a prior course of horse or rabbit ATG given greater than 6 months ago:
• meeting again the criteria for SAA
• requirement for transfusion support (if not due to independent medical conditions)
• decrease in any of the peripheral blood counts as follows
• absolute neutrophils < 0.5 x 10^9/L
• platelets <20 x 10^9/L
2. Age >18
3. Negative pregnancy test for women of child bearing potential
Exclusion
1. Evidence of a myelodysplastic syndrome, defined according to the World Health Organization 2017 criteria. Patients with AA with cytogenetic abnormalities, which 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.
2. 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
3. Cancer diagnosis within the last 5 years (except for patients with resected basal cell carcinoma or squamous cell carcinoma of the skin)
4. Previous history of melanoma
5. Pregnant or breast feeding patients2
6. Participants with known hypersensitivity to avatrombopag
7. Severe renal impairment (defined as creatinine clearance =30m/min)
8. Treatment with horse or rabbit ATG within 6 months of trial entry. Concurrent treatment with Cyclosporine A is permitted.
9. 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.
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 iN Relapsed or Refractory severe Aplastic Anaemia as EXtra Therapy - a Bayesian Optimal Phase II study
Get Support
You might find it helpful to speak to someone who has 'been there before'. Our Peer Connect program can provide one-on-one phone support from someone who understands what you're going through and has clinical trials experience.
Know more about Peer Connect
If you need cancer information and practical support for yourself, a carer, family or friend, contact Cancer Council to speak with an experienced health professional on 13 11 20.
Get support
Learn more about clinical trials through this collection of resources in languages other than English.
View information