An interventional study of FDG-PET/CT and Conventional CT in Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia and Haematopoietic Stem Cell Transplant, Autologous, sponsored by Peter MacCallum Cancer Centre, Australia. Completed at 2 sites in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-17.
Sponsored by Peter MacCallum Cancer Centre, Australia · Not applicable, Interventional, and Diagnostic
Among 148 studies in Leukemia, Myeloid, Acute with a site in Australia — 23 open to participants now, 45 under way, 17 of them phase 3. Leukemia, Myeloid, Acute · Australia.
Among the 148 studies in Leukemia, Myeloid, Acute with a site in Australia, this one is the 57th largest by enrollment of the 144 interventional ones, is one of 15 that started in 2018, is one of 2 with no phase, and was the 68th registered.
3,667 studies on the registry are indexed under Leukemia, Myeloid, Acute; 816 are open to participants now.
This study's enrollment of 147 is above the median of 40 across 3,005 interventional studies indexed under Leukemia, Myeloid, Acute.
Browse Leukemia, Myeloid, Acute studies →23 of the 148 studies in Leukemia, Myeloid, Acute with a site in Australia are open now, in 12 countries. Each count lists the studies.
Of the 620 Leukemia, Myeloid, Acute studies recruiting now, 358 (58%) set no upper age limit and 221 (36%) stop at 75 or younger; 145 take children under 18; 28 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →148 studies; the count open now beside each. This study's row is marked.
First in 1997; this study’s year is marked. 15 started in 2018.
Median enrollment 108 across the 144 interventional studies, 25 across the 3 observational. Of the 95 that completed or were terminated, 50 (53%) have results posted.
113 of 148 have an industry lead sponsor. The 10 most frequent:
Peter MacCallum Cancer Centre, Australia is the lead sponsor of 82 studies on the registry; 25 are open to participants now.
Peter MacCallum Cancer Centre, Australia has 3 studies filed under Leukemia, Myeloid, Acute — fewer than ten, so there is no comparison to draw.
9 of the studies in Leukemia, Myeloid, Acute with a site in Australia that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05183035Phase 3PedAL BCU, LLCVenetoclax in Children With Relapsed Acute Myeloid Leukemia (AML) | 2027-02 |
| NCT03839771Phase 3Stichting Hemato-Oncologie voor Volwassenen NederlandA Study of Ivosidenib or Enasidenib in Combination With Induction Therapy and Consolidation Therapy, Followed by Maintenance Therapy in Patients With Newly Diagnosed Acute Myeloid Leukemia or Myedysplastic Syndrome EB2, With an IDH1 or IDH2 Mutation, Respectively, Eligible for Intensive Chemotherapy | 2027-04-17 |
| NCT03844048Phase 3AbbVieAn Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial | 2027-08 |
| NCT03850574Aptose Biosciences Inc.Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Tuspetinib (HM43239) in Patients With Relapsed or Refractory Acute Myeloid Leukemia | 2026-11 |
| NCT05659732PharmaEngineA Study of PEP07 (Checkpoint Kinase 1 Inhibitor) in Patients With Advanced Cancer | 2026-12-31 |
Among the 148 studies in Leukemia, Myeloid, Acute with a site in Australia, from their registry updates:
Patients with acute leukaemia requiring induction or consolidation chemotherapy and those requiring a haematopoietic stem cell transplant are at high risk of fever and infection when they have low white cell counts (neutropenic fever). The causes of neutropenic fever are frequently unknown and patients are treated with broad antibiotics, without a clear target to what is being treated.
This study will prospectively enroll patients who are receiving chemotherapy for acute leukaemia or for a stem cell transplant and compare the diagnostic utility of bacterial and fungal PCR performed directly off blood drawn, to the standard blood culture. Patients who have persistent fever after 72 hours of antibiotics will then be randomized to have either the interventional scan (PET/CT) or the conventional scan (standard CT) to look for a source of infection. Diagnostic yield, change in management and outcomes will be compared between arms.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with persistent febrile neutropenia after 72 hours of onset who are randomized to this arm will have an FDG-PET/CT performed to look for source of fever.
Diagnostic Test: FDG-PET/CT
Participants with persistent febrile neutropenia after 72 hours of onset who are randomized to this arm will have a conventional CT (HRCT chest and sinuses +/- other regions as per clinician's discretion) performed to look for source of fever.
Diagnostic Test: Conventional CT
FDG-PET performed with low dose CT
Also known as: PET/CT
HRCT and CT of sinuses +/- other regions as per clinician's discretion
Change in management following randomized scan
Defined as: * referral for targeted sampling, referral for surgery * change in antimicrobial therapy * removal of a central line
Time frame: Within 48 hours of scan result
Proportion of participants with a cause of neutropenic fever
The proportion of participants in each arm where there is a confirmed cause of neutropenic fever
Time frame: By hospital discharge, an average of 4 weeks
Hospital length of stay
The duration (in days) of hospital length of stay for the episode in which neutropenic fever occurred
Time frame: By hospital discharge, an average of 4 weeks
Costs of hospital care
The overall cost of the inpatient stay for the episode in which neutropenic fever occurred
Time frame: By hospital discharge, an average of 4 weeks
Proportion admitted to intensive care
The proportion of patients in each arm who were admitted to intensive care during their admission in which neutropenic fever occurred
Time frame: By hospital discharge, an average of 4 weeks
In hospital mortality
The proportion of patients per arm who have passed away during the admission in which neutropenic fever occurred
Time frame: By hospital discharge, an average of 4 weeks
6 month mortality
The proportion of patients per arm who have passed away 6 months post study entry
Time frame: 6 months from study entry
Plan to share: Undecided
Ran from Jan 2018 to primary completion in Aug 2020, 30 months.
Of 132 non-industry interventional studies with no phase under Leukemia, Myeloid, Acute, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 128. This study's 30 months is below that.
Counting every sponsor, half of 139 studies reached it within 47 months; a quarter within 25 and three quarters within 123.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Peter MacCallum Cancer Centre, Australia