Randomised Trial in Waldenstrom's Macroglobulinaemia

PHASE2CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

January 31, 2013

Primary Completion Date

March 31, 2017

Study Completion Date

August 2, 2020

Conditions
Waldenstrom's Macroglobulinaemia
Interventions
DRUG

Bortezomib

1.6 mg/m2 subcutaneous bortezomib on days1, 8 and 15 of 28 days cycle

DRUG

Cyclophosphamide

"Cyclophosphamide:250 mg/sq m, oral, days 1, 8 and 15 of each cycle in the experimental arm.~Cyclophosphamide:250 mg/sq m, oral, days 1, 2 and 3 of each cycle in the control arm."

BIOLOGICAL

Rituximab

Rituximab: 375 mg/m2 i.v. infusion; days 1, 8, 15 and 22 of cycles 2 and 5 only

DRUG

Fludarabine

Fludarabine: 40 mg/sq m, oral, days 1, 2 and 3

Trial Locations (30)

Unknown

Basingstoke & North Hampshire Hospital, Basingstoke

Royal United Hospital, Bath

City Hospital, Birmingham

Pilgrim Hospital, Boston

Colchester General Hospital, Colchester

Darent Valley Hospital, Dartford

Dewsbury and District Hospital, Dewsbury

Royal Devon and Exeter Hospital, Exeter

Grantham and District Hospital, Grantham

Leicester Royal Infirmary, Leicester

Lincoln County Hospital, Lincoln

Royal Liverpool University Hospital, Liverpool

King's College Hospital, London

Northwick Park Hospital, London

Royal Free Hospital, London

Maidstone Hospital, Maidstone

Derriford Hospital, Plymouth

Pontefract Hospital, Pontefract

Queen's Hospital, Romford

Tunbridge Wells Hospital, Royal Tunbridge Wells

Salisbury District Hospital, Salisbury

Musgrove Park Hospital, Taunton

Torbay Hospital, Torquay

Pinderfields Hospital, Wakefield

Sandwell Hospital, West Bromwich

Royal Hampshire County Hospital, Winchester

B9 5SS

Birmingham Heartlands Hospital, Birmingham

LS9 7TF

St James University Hospital, Leeds

EC1A 7BE

St Bartolomew's Hospital, London

NW1 2BU

University College Hospital, London

All Listed Sponsors
lead

University College, London

OTHER

NCT01592981 - Randomised Trial in Waldenstrom's Macroglobulinaemia | Biotech Hunter | Biotech Hunter