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Ofatumumab (Humax-CD20) With CHOP (Cyclophosphamide,Doxorubicin, Vincristine, Predisolone) in Follicular Lymphoma (FL) Patients

NCT00494780 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2014-07-11

Study results available
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Summary

To investigate the efficacy in two dose regimens of ofatumumab in combination with CHOP (cyclophosphamide,doxorubicin, vincristine,prednisolone) in previously untreated patients with Follicular Lymphoma (FL)

Conditions

  • Lymphoma, Follicular

Interventions

DRUG

Ofatumumab

ofatumumab 300mg, 500mg or 1000mg should be diluted into 1000mL pyrogen free saline and administered as an IV infusion.Duration of infusion will be approximately 4 hours.Infusions should be given every 3 weeks until a total of 6 infusions has been given

DRUG

Cyclophosphamide

Cyclophosphamide 750 mg/m2 iv for 1 day, 24-48h post-ofatumumab infusion start

DRUG

Doxorubicin

Doxorubicin : 50mg/m2 iv for 1 day, 24-48h post-ofatumumumab infusion start

DRUG

Vincristine

Vincristine : 1.4mg/m2 iv for 1 day, 24-48h post-ofatumumab infusion start

DRUG

Prednisolone, Prednisone or equivalent

100mg p.o daily for 5 days, 24-48h post-ofatumumab infusion start

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2009-04-30
Completion
2010-09-30

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00494780 on ClinicalTrials.gov