Study for people with Leukaemia

Recruiting Not a phased study

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

This trial at a glance

Status Recruiting
Phase Not a phased study
Sponsor Peter MacCallum Cancer Centre, Australia
Registry number NCT07051525
Started 3 December 2025 Today 16 October 2026 Estimated completion 5 December 2027

Where this trial is running

Trial sites and the status recorded for each
SiteCityState or countryStatus at this site
Peter MacCallum Cancer Centre Melbourne VIC Recruiting
Royal Melbourne Hospital Melbourne VIC Recruiting

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 214

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:

Adult patients ( ≥18 years) who are receiving either:

* Conditioning chemotherapy for an autologous or allogeneic haematopoietic cell transplant or CAR T cell therapy, OR

* Induction remission chemotherapy for acute leukaemia,

AND develop fever ( ≥38degC) between time of initiation of chemotherapy/conditioning administration and ANC recovery to ≥500 cells/mm3 post the ANC nadir,

AND fever subsequently has settled (\<38degC) for ≥48 and \<96h hours.

\[participants will be stratified into pre-neutropenic (ANC ≥500 cells/mm3) and neutropenic (ANC\<500 cells/mm3) strata based on ANC level at 48 hours post fever onset, as per international consensus definition of neutropenic fever\]

Exclusion Criteria:

* \- Prolonged fever prior to defervescence (documented daily temperature ≥38.0°C for ≥ 5 days)

* Documented positive blood culture for bacteria since onset of fever episode and prior to randomisation

* Documented other infection (clinically or microbiologically defined) requiring antibacterial treatment

* Grade 2 or higher mucositis (WHO) or neutropenic enterocolitis

* Clinically unstable and/or admission to ICU at time of potential randomization

* Within 28 days of last randomization

* Prior randomization during current chemotherapy/conditioning cycle

* Pregnant or breastfeeding

* Currently being treated for CRS Grade 3 or 4, and/or ICANS Grade 3 or 4 (defined as per ASTCT Consensus Guidelines, Lee et al)

Dates on the record

Started 3 December 2025
Estimated completion 5 December 2027
Registry last updated 15 December 2025
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: 15 December 2025.
  • 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.