Chemotherapy With Monoclonal Antibody and Radioimmunotherapy for High-Risk B-Cell Non-Hodgkins Lymphoma

PHASE2CompletedINTERVENTIONAL
Enrollment

39

Participants

Timeline

Start Date

June 18, 2005

Primary Completion Date

April 8, 2012

Study Completion Date

November 3, 2016

Conditions
Lymphoma, B-Cell
Interventions
DRUG

cyclophosphamide

1.5g/m2 IV over 1 hour on days 1-4 of induction for a total dose of 6.0g/m2

DRUG

etoposide

300mg/m2 IV over 1 hour every 12 on days 1-3 of induction for a total dose of 1.8 g/m2.

DRUG

rituximab

375mg/m2 each week x 4 weeks of induction, beginning on day 1

DRUG

cytarabine

3g/m2 IV over 1 hour every 12 during consolidation for a total of 8 doses

DRUG

doxorubicin

45mg/m2/day IV over 30 minutes on days 1, 2, 3 during consolidation

DRUG

tositumomab

450mg unlabeled tositumomab over 1 hour, followed by 5 millicurie (mCi) Iodine I-131 labeled tositumomab over 20 minutes on day 0. Therapeutic dose of labeled tositumomab will be administered on day 15.

Trial Locations (1)

27710

Duke University Medical Center, Durham

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

lead

Duke University

OTHER