Phase II Study of Fractionated 90Y Ibritumomab Tiuxetan (Zevalin) Radioimmunotherapy as an Initial Therapy of Follicular Lymphoma

PHASE2CompletedINTERVENTIONAL
Enrollment

76

Participants

Timeline

Start Date

June 6, 2007

Primary Completion Date

January 31, 2011

Study Completion Date

November 6, 2015

Conditions
Follicular Lymphoma
Interventions
DRUG

90Y Ibritumomab tiuxetan

2 x iv infusions of 11.1 MBq/kg. 1st infusion at week 1, 2nd during weeks 9-13. 2nd infusion may be reduced to 7.4MBq/kg in the case of grade 3 haematological toxicity following the 1st infusion.

DRUG

Rituximab

"All patients receive 2 x iv infusions of 250 mg/m2 Rituximab given 7-8 days apart prior to each zevalin infusion. The 2nd rituximab infusion is given immediately prior to Zevalin.~In addition patients with greater than 20% bone marrow involvement at screening receive rituximab pretreatment prior to entering the main treatment phase of the trial, consisting of 4 x weekly iv doses of rituximab(375 mg/m2). This is followed by a repeat bone marrow biopsy, bone marrow involvement must have fallen to \<= 20% to enter the main treatment phase of the trial."

Trial Locations (7)

Unknown

Centre Hospitalier Universitaire de Lille, Lille

Centre Hospitalier Universitaire de Nantes, Nantes

Centre Henri Becquerel, Rouen

St George's Hospital, London

Poole Hospital NHS Foundation Trust, Poole

Southampton University Hospital, Southampton

M20 4BX

The Christie NHS Foundation Trust, Manchester

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bayer

INDUSTRY

lead

The Christie NHS Foundation Trust

OTHER