Early Versus Late Stopping of Antibiotics in Adults With High-risk Hematological Malignancies/Receiving Cellular Therapies and Fever

Launched by PETER MACCALLUM CANCER CENTRE, AUSTRALIA · Jun 25, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at the best time to stop antibiotics in adults who develop a fever after receiving treatment for serious blood cancers like leukemia, or after therapies such as stem cell transplants or CAR T-cell therapy. Usually, when patients get a fever during or after these treatments, doctors start antibiotics right away to fight infection. However, sometimes no infection is found, and the fever goes away quickly. This study wants to find out if it’s safe to stop antibiotics earlier than usual in these cases, which could help reduce side effects and the chance of antibiotic resistance.

Adults who are receiving chemotherapy for leukemia, stem cell transplants (using their own or donor cells), or CAR T-cell therapy, and who develop a fever during treatment but then see their fever settle within 2 to 4 days, may be eligible to join. Participants will be carefully monitored in the hospital, and if antibiotics are stopped early, they can be restarted quickly if any signs of infection return. The study will compare this early stopping approach to the current standard practice, which keeps patients on antibiotics until their white blood cell counts recover. This research will help doctors understand if stopping antibiotics sooner is safe and beneficial for patients like you or your loved one.

Gender

ALL

Eligibility criteria

• 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)