Comparison Study of Standard Care Against Combination of Growth Factors Agents for Low-risk Myelodysplastic Syndromes

PHASE3CompletedINTERVENTIONAL
Enrollment

360

Participants

Timeline

Start Date

November 1, 2010

Primary Completion Date

October 31, 2015

Study Completion Date

October 31, 2015

Conditions
Myelodysplastic Syndrome
Interventions
DRUG

Darbepoetin alpha

Aranesp 500 mcg vials once every 2 weeks.

DRUG

Filgrastim

300 mcg vials twice a week, 3-4 days apart

PROCEDURE

Blood Red Cell Transfusion

Red cell transfusion support to achieve a predicted post-transfusion haemoglobin of 11.0 to 12.0 g/dl at a quantity and frequency such that the minimum haemoglobin is never below 8.0 g/dl or such that the patient is never excessively symptomatic, according to local transfusion guidelines/policy.

Trial Locations (4)

B15 2TT

Birmingham Cancer Research UK Clinical Trial Unit, Birmingham

EC1A 7BE

St Bartholomew's Hospital, London

EC1M 6BQ

CECM Institute of Cancer, London

SE5 9RS

King's College Hospital Haematoloy Laboratory, London

Sponsors

Collaborators (2)

All Listed Sponsors
collaborator

Cancer Research UK

OTHER

collaborator

Amgen

INDUSTRY

lead

Barts & The London NHS Trust

OTHER