Phase 2 study

Not yet recruiting Phase 2

Sources: ClinicalTrials.gov Checked: 11 October 2026 Not medical advice

This trial at a glance

Status Not yet recruiting
Phase Phase 2
Sponsor Melbourne Health
Registry number NCT06607367
Started 30 October 2024 Today 16 October 2026 Estimated completion 30 October 2025

Past estimated completion. The registry still lists this trial as open, and the date it gave for finishing has been and gone. Confirm with the official record before you act on it.

Where this trial is running

Trial sites and the status recorded for each
SiteCityState or countryStatus at this site
The Royal Melbourne Hospital Parkville VIC Status not stated

voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice

Who can join

Age 18 Years and over
Sex Anyone, regardless of sex
Healthy volunteers Not accepted
Enrolment target 20

The official eligibility criteria

Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.

Inclusion Criteria:

Patient must meet ALL of the following:

1. Poor Graft function OR Relapsed/refractory AA

1. Poor Graft Function defined as follows:≥95% donor chimerism at last reading OR ≥95% CD3 negative chimerism; ≥2 Lineage cytopenias defined as:

Thrombocytopenia:

* 30x109 /L from D40-D60 OR

* 50 x10 9/L from D60 onwards; Neutropenia requiring filgrastim support at any time post D40; Hb less than 80g/L;

2. Relapsed /Refractory AA defined as: Relapse after stem cell transplant OR relapsed post/refractory to 1st line immunosuppression without an unrelated donor identified.

2. Age ≥18

3. ECOG performance status 0-1

4. Life expectancy greater than 6 months

5. Patient's written informed consent

Exclusion Criteria:

1. Active Grade 3-4 acute GVHD

2. Relapsed or progressive disease on screening bone marrow biopsy or most recent PET imaging.

3. Active second malignancy currently requiring treatment

4. Human Immuno-deficiency Virus (HIV) infection.

5. Any coexisting medical or psychological condition that would preclude participation in the required study procedures.

6. Female patients who are both lactating and breast-feeding or have a positive serum pregnancy test during the screening period or a positive pregnancy test on Day 1 before first dose of study drug

Dates on the record

Started 30 October 2024
Estimated completion 30 October 2025
Registry last updated 23 September 2024
Checked by Voxsanity 11 October 2026

Results, publications and the official record

Sources and dates

  • ClinicalTrials.gov – the record this page reformats
  • ClinicalTrials.gov processing date: 23 September 2024.
  • This page last checked by Voxsanity: 11 October 2026.

Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.

Not medical advice.

Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.

Letter for your doctor

A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.