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
Secondary identifying numbers	G8223452 - MRC IFI

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

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
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	1. Resolution of fever 2. Resolution of radiological and microbiological signs of infection
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/06/1997
Completion date	30/06/1997

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target number of participants	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

Medical Research Council (MRC) (UK)
Research council

20 Park Crescent
London
W1B 1AL
United Kingdom

Phone	+44 (0)20 7636 5422
Email	clinical.trial@headoffice.mrc.ac.uk
Website	http://www.mrc.ac.uk

Industry

Medical Research Council (MRC) (UK)
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

Norvartis Pharmaceuticals (UK)

No information available

Nexstar Pharmaceuticals (UK)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	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.