InformationClinical trials have complex eligibility criteria.
Always talk to your clinician about you’re interest in participating in a trial.
Learn why

Optimise reading forHealth ProfessionalsPatients

RecruitingLast updated: 7 February 2024

The DIAAMOND-Ava NEXT Trial: In this phase II trial, patients with severe aplastic anaemia who have been treated with, but not responded to immunosuppressive therapy (IST), will receive a new drug (avatrombopag) as a potential treatment for their conditionAvatrombopag iN Relapsed or Refractory severe Aplastic Anaemia as EXtra Therapy - a Bayesian Optimal Phase II study

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 patients with aplastic anaemia

Cancer

Blood Cancers Haematological

Age

People18+

Phase

II

Trial Acronym

The DIAAMOND-Ava NEXT Trial

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

Monash University

Scientific Title

Avatrombopag iN Relapsed or Refractory severe Aplastic Anaemia as EXtra Therapy - a Bayesian Optimal Phase II study

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.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

Participating hospitals

Recruiting hospitals

InformationTell us if you find this trial availability is not accurate.Report inaccuracy

Get Support

Example

Cancer Connect

You might find it helpful to speak to someone who has 'been there before'. Our Cancer Connect program can provide one-on-one phone support from someone who understands what you're going through and has clinical trials experience.

Learn more

Example

Cancer Council’s cancer nurses

If you need cancer information and practical support for yourself, a carer, family or friend, contact Cancer Council’s experienced cancer nurses on 131120.

Learn more

Example

Information for family, friends and carers

When you are considering a cancer clinical trial, it is a good idea to discuss it with your family, friends or carers.

Learn more

Victorian Cancer Registry Victorian Government

The Victorian Cancer Trials Link is supported by the Victorian Government through the Victorian Cancer Agency.

RAP

Cancer Council Victoria would like to acknowledge the traditional custodians of the land on which we live and work. We would also like to pay respect to the elders past and present and extend that respect to all other Aboriginal people.