Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
G8223452 - MRC IFI
Study information
Scientific title
Supplementary Study for Patients With Invasive Fungal Infection, Entered Into AML 11, AML 12 and UKALL XII or Their Successors
Acronym
Study hypothesis
To assess the effect of GM-CSF on the outcome of fungal infection after treatment for leukaemia
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measure
1. Resolution of fever
2. Resolution of radiological and microbiological signs of infection
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/06/1997
Overall trial end date
30/06/1997
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
200
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/06/1997
Recruitment end date
30/06/1997
Locations
Countries of recruitment
United Kingdom
Trial participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
Medical Research Council (MRC) (UK)
Sponsor details
20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Industry
Funder name
Medical Research Council (MRC) (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Funder name
Norvartis Pharmaceuticals (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Nexstar Pharmaceuticals (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list