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Bendamustine Combined With Rituximab for Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

NCT00831597 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2016-04-19

No results posted yet for this study

Summary

A phase II trial to evaluate the efficacy and safety of combination bendamustine and rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma. It is hypothesized that the BR combination will produce at least a 70% overall response rate.

Conditions

  • Diffuse Large B-Cell Lymphoma

Interventions

DRUG

bendamustine

120 mg/m2 IV, Days 1, 2 of Cycles 1-6

DRUG

rituximab

375 mg/m2 IV, Day 1 of Cycles 1-6

Sponsors & Collaborators

  • Cephalon

    collaborator INDUSTRY

  • Pharmatech

    lead INDUSTRY

Principal Investigators

  • Jeffrey L Vacirca, MD, FACP · University Hospital, Stony Brook North Shore Hematology/Oncology Associates

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2013-08-31
Completion
2013-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT00831597 on ClinicalTrials.gov