None listed
Conditions
Brief summary
The AMLM28/A3 study is part of the ADAPT platform trial (ACTRN12623000900617), which is testing new ways to treat acute myeloid leukaemia (AML). The ADAPT trial will enroll patients unfit for intensive chemotherapy and planned to receive Venetoclax and Azacitidine (VEN-AZA) as standard of care. This study is looking at whether ambulatory management for fever related hospitalisation is more effective than the current standard of care. Who is it for? Patients enrolled on the ADAPT platform trial who have achieved a remission of their AML after VEN-AZA treatment and require hospitalisation due to a fever. Study Details. This is a randomised study where patients will be randomised 1:1 to either receive the ambulatory management compared to the standard of care for fever-related hospitalisation in AML patients enrolled in the ALLG ADAPT platform trial. A total of 100 patients will be recruited across Australian sites. This study aims to determine if ambulatory management can reduce the duration of the time spent in the hospital when AML patients are readmitted due to a fever, after responding to treatment VEN-AZA.
Interventions
The intervention will involve an ambulatory model of care for fever management whilst awaiting neutrophil recovery. Participating patients will be assessed after 48 hours of admission for appropriateness for registration and randomisation to ambulatory model vs standard of care. Randomisation can occur anytime within 7 days of admission.
The interventional ambulatory model of care will consist of:
1. Continued oral antibiotics may commence at onset or after 24 hours of being randomised to th
The intervention will involve an ambulatory model of care for fever management whilst awaiting neutrophil recovery. Participating patients will be assessed after 48 hours of admission for appropriateness for registration and randomisation to ambulatory model vs standard of care. Randomisation can occur anytime within 7 days of admission. The interventional ambulatory model of care will consist of: 1. Continued oral antibiotics may commence at onset or after 24 hours of being randomised to the study. Antibiotic administration is anticipated for approximately 7 days, or until the participant has a temperature of under 38 degrees celsius for at least 24 hours and the absolute neutrophil count (ANC) has recovered to greater than 0.5 × 10^9, The duration and treatment is at the discretion of the treating physician with the following options: a. No beta-lactam allergy: Amoxicillin-clavulanate 875/125mg twice a day Ciprofloxacin 750mg twice a day b. Beta-lactam allergy: Clindamycin 450mg three times daily Ciprofloxacin 750mg twice a day c. Fluoroquinolone allergy: Amoxicillin-clavulanate 875/125mg twice a day At least one dose of oral antibiotics should be given prior to hospital discharge in order to monitor for side effects. 2. Full blood examination neutropenia monitoring once weekly (considered standard of care monitoring) 3. Hospital in the home or haematology registrar review (standard of care clinical monitoring) 4. Clinical monitoring as per standard of care: minimum of at least 1 clinical review between randomisation and day 7. 5. Safety visit: 1 week post randomisation 6. End of study visit: 4 weeks post randomisation All treatment will be administered by the study team (i.e., registered nurse, the lead physician, physicians listed on the trial to assist the lead physician). Drug accountability will be performed by the administering institutions to assess compliance through pharmacy dispensing logs, dose administration records, and verifying patient diaries.
Sponsors
Australasian Leukaemia and Lymphoma Group
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All of the criteria from the AMLM28 Master Protocol (ACTRN12623000900617) must be satisfied for enrolment in the study as well as the below: 1. Consented and registered to the ALLG’s National Blood Cancer Registry (NBCR) . 2. Achieved remission of their Acute myeloid leukemia (AML) defined as complete remission (CR) CRH and CR 60% per the response definition criteria listed in the AMLM28 master protocol. 3. Neutrophils greater than 0.5 x109/L with no upper limit 4. Inpatient hospitalisation for fever (defined as at least 1 recorded or patient-reported temperature above 38.0 degree Celsius) a. Only one episode of fever hospitalisation will be considered per patient. 5. Assessment for early discharge has been completed, and all items are confirmed yes. Note: If an item is answered no, reassessment will occur again in the 24–48-hour window for up to 7 days from admission.
Exclusion criteria
Presence of any of the criteria from the AMLM28 Master Protocol (ACTRN12623000900617) will exclude the patient from enrolment in the study in addition to the below criteria: 1. History of over 3 day intensive care unit (ICU) admission in the last 3 months for any reason. 2. History of severe (requiring inotropes, ICU admission, not responsive to first line appropriate antibiotics) gram negative bacteremia in the last 3 months. 3. Known multidrug resistant gram-negative colonisation.
Outcome results
None listed