Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
18/12/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr - -

ORCID ID

Contact details

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

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 measures

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

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 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Industry

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

18/12/2015: No publications found on PubMed.