Supplementary Study for Patients With Invasive Fungal Infection, Entered Into AML 11, AML 12 and UKALL XII or Their Successors

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN75343446

Enrollment

200

Registered

2002-08-19

Start date

1997-06-01

Completion date

Unknown

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukaemia (acute) Cancer Leukaemia (acute)

Interventions

1. Arm A: Placebo given by subcutaneous injection plus liposomal amphoterecin (AmBisome) at a dose of 3 mg/Kg per day by intravenous infusion for those with proven infection and 1 mg/Kg per day by int

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients entered into the MRC trials AML 11, AML 12, or UKALL XII, or their successors 2. The following classification of fungal infection in leukaemia patients eligible for this trial are a. Pulmonary fungal infection - proven or suspected b. Sinus infected - proven or suspected c. Fungemia - suspected d. Chronic hepatosplenic candidosis - proven by Computed Tomography (CT)/Magnetic Resonance Imaging (MRI) e. Invasive cutaneous infection - proven f. Cerebral fungal infection - proven or suspected 3. Karnofsky performance status of at least 30% 4. Patients with known intolerance to either test drug are excluded 5. Previous use of AmBisome within 2 weeks, or use of granulocyte-macrophage colony-stimulating factor (GM-CSF) within 3 months excludes a patient 6. Life expectancy of >6 weeks 7. Aged >15 years

Exclusion criteria

Exclusion criteria: Not provided at time of registration

Design outcomes

Primary

Measure	Time frame
1. Resolution of fever 2. Resolution of radiological and microbiological signs of infection	—

Secondary

Measure	Time frame
Not provided at time of registration	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026