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Study to Evaluate the Efficacy and Safety of Treatment With Bendamustine in Combination With Ofatumumab in Previously Untreated Patients With Indolent B-Cell Non-Hodgkin's Lymphoma (NHL)

NCT01108341 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2012-08-28

Study results available
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Summary

The primary objective of the study is to determine the efficacy, as measured by overall response (complete response + partial response) of bendamustine in combination with ofatumumab in previously untreated patients with indolent B-Cell Non-Hodgkin's Lymphoma (NHL).

Conditions

  • Non-Hodgkin's Lymphoma (NHL)

Interventions

DRUG

Bendamustine hydrochloride

Bendamustine will be administered at 90 mg/m\^2 as a 30-minute intravenous (iv) infusion on days 1 and 2 of each cycle.

DRUG

Ofatumumab

Ofatumumab will be administered at 300 mg as an iv infusion on day 1 and 1000 mg on day 8 of cycle 1 and 1000 mg on day 1 of each subsequent cycle.

Sponsors & Collaborators

  • Cephalon

    lead INDUSTRY

Principal Investigators

  • Sponsor's Medical Expert · Cephalon

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2011-07-31
Completion
2011-10-31

Countries

  • United States
  • Belgium
  • Israel

Study Locations

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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 NCT01108341 on ClinicalTrials.gov