Phase 2 study for people with Leukaemia
Recruiting Phase 2
This trial at a glance
Where this trial is running
| Site | City | State or country | Status at this site |
|---|---|---|---|
| Royal Prince Alfred | Sydney | NSW | Recruiting |
voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice
Who can join
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.
Key Inclusion Criteria:
1. Male or female, ≥ 1 year of age.
2. Participants with body weight ≥ 40 kilogram.
3. A) Relapsed or refractory T-ALL/LBL or MRD positive defined as one of the following:
* Relapsed or refractory disease after two or more lines of systemic therapy;
* The first relapse occurs within 12 months after first remission;
* Relapse after allogeneic HSCT and must be ≥100 days from HSCT prior to screening period.
B) Minimal Residual Disease (MRD) positive T-ALL/LBL is defined as evidence of MRD, defined as \< 5% blasts in bone marrow but ≥ 1 cancer cell in 1,000 cells determined by NGS ClonoSEQ® and/or other regionally acceptable methodologies (e.g., EuroMRD guidelines).
4. The presence of bone marrow lymphoblasts is ≥ 5% as determined by morphologic evaluation or evidence of extramedullary disease at screening.
5. Adequate organ function
6. ECOG of 2 or less or Karnofsky PS ≥ 60 (for participants age ≥ 16) or Lansky PS ≥ 60 (for participants \< 16) at screening.
Key Exclusion Criteria:
1. Participants with concomitant genetic syndromes associated with bone marrow failure states or any other known bone marrow failure syndrome.
2. Active central nervous system (CNS) involvement
3. Participants with following cardiac conditions will be excluded:
1. History of heart failure New York Heart Association (NYHA) class III or IV;
2. History of myocardial infarction, cardiovascular angioplasty or stenting, unstable angina, or other serious heart diseases within 12 months of enrollment.
4. Primary immune deficiency.
5. Presence of uncontrolled infections.
6. Known history of infection with the human immunodeficiency virus (HIV); hepatitis C virus and syphilis.
7. Active or latent hepatitis B virus infection
8. Epstein-Barr virus (EBV), Cytomegalovirus (CMV) DNA or IgM positive at screening.
Dates on the record
Results, publications and the official record
- No results are posted on the official record yet.
- No publications are listed on the official record yet.
- Official record and contacts on ClinicalTrials.gov – contact details for each site are kept there, and are not copied onto this page.
Sources and dates
- ClinicalTrials.gov – the record this page reformats
- ClinicalTrials.gov processing date: 19 August 2026.
- 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.