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

ISRCTN	ISRCTN75343446
DOI	https://doi.org/10.1186/ISRCTN75343446
Protocol serial number	G8223452 - MRC IFI
Sponsor	Medical Research Council (MRC) (UK)
Funders	Medical Research Council (MRC) (UK), Norvartis Pharmaceuticals (UK), Nexstar Pharmaceuticals (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr - -
Scientific

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Supplementary Study for Patients With Invasive Fungal Infection, Entered Into AML 11, AML 12 and UKALL XII or Their Successors
Study objectives	To assess the effect of GM-CSF on the outcome of fungal infection after treatment for leukaemia
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Leukaemia (acute)
Intervention	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 intravenous infusion for those with suspected infection. 2. Arm B: GM-CSF at an initial dose of 5 µg/Kg/day by subcutaneous injection plus liposomal amphoterecin (AmBisome) at an initial dose of 3 mg/Kg/day by intravenous infusion for those with proven infection and 1 mg/Kg/day by intravenous infusion for those with suspected infection.
Intervention type	Other
Primary outcome measure(s)	1. Resolution of fever 2. Resolution of radiological and microbiological signs of infection
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	30/06/1997

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target sample size at registration	200
Key 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
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/06/1997
Date of final enrolment	30/06/1997

UKCCCR Register Co-ordinator

London
NW1 2DA
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

31/10/2019: No publications found. All search options exhausted.
18/12/2015: No publications found on PubMed.