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Ofatumumab and Bendamustine for Previously Treated Chronic Lymphocytic Leukemia (CLL)

NCT01010568 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2015-12-15

Study results available
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Summary

The purpose of this study is to evaluate the safety and effectiveness of the combination of bendamustine and ofatumumab in subjects with relapsed/refractory chronic lymphocytic leukemia and small cell lymphoma. All subjects enrolled on this study will receive both drugs by intravenous (IV) infusion.

Conditions

Interventions

DRUG

Ofatumumab and Bendamustine

Ofatumumab 300-mg IV on Day 1 of week -1 and then 1000 mg on Day 1 of each cycle for 6 cycles Bendamustine 70 mg/m2 IV on days 1 and 2 of each cycle for 6 cycles

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Cephalon

    collaborator INDUSTRY

  • Georgetown University

    lead OTHER

Principal Investigators

  • Bruce Cheson, MD · Georgetown University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2014-05-31
Completion
2014-08-31

Countries

  • United States

Study Locations

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Entities

Diseases
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 NCT01010568 on ClinicalTrials.gov