Safety and Efficacy of Treanda™ (Bendamustine HCl) in Patients With Indolent Non-Hodgkin's Lymphoma (NHL) Who Are Refractory to Rituximab

May 8, 2014 updated by: Cephalon

A Multi-Center Phase III Study to Investigate the Safety and Efficacy of Treanda™ (Bendamustine HCl) in Patients With Indolent Non-Hodgkin's Lymphoma (NHL) Who Are Refractory to Rituximab

SUMMARY: This is a multi-center open label study to evaluate the safety and effectiveness of Treanda™ (also known as bendamustine HCl or SDX-105) in patients who have indolent Non-Hodgkin's lymphoma and have relapsed within a defined timeframe after taking rituximab (Rituxan®). Treanda will be given via 60-minute intravenous infusion on days 1 and 2 of every 21-day treatment cycle. Patients will be treated for 6 cycles unless they develop progressive disease or unacceptable toxicity. Those who continue to receive clinical benefit at end of 6 cycles may receive an additional 2 cycles. Following the end of treatment, patients will be followed for up to 2 years until disease progression or start of another anti-cancer therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

103

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • British Columbia Cancer Agency
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Queen Elizabeth Health Sciences Centre
    • Ontario
      • Ottawa, Ontario, Canada, KIH8L6
        • Ottawa Hospital - General Campus
    • Quebec
      • Montreal, Quebec, Canada, H2: 4M1
        • Hopital Notre-Dame du CHUM
      • Montreal, Quebec, Canada, H4J 1C5
        • Hopital du Sacre Couer de Montreal
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 4H4
        • Saskatchewan Cancer Center Agency
  • Puerto Rico
      • San Juan, Puerto Rico, 00919
        • Hospital Espanol Auxilio Mutuo, Auxilio Mutuo Cancer Center
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama Birmingham
    • Arizona
      • Tucson, Arizona, United States, 85724
        • Arizona Cancer Center
    • California
      • Berkeley, California, United States, 94704
        • Alta Bates Comprehensive Cancer Center
      • Beverly Hills, California, United States, 90211
        • Tower Hematology and Oncology Medical Group
      • La Jolla, California, United States, 92093
        • Moores UCSD Cancer Center
      • Los Angeles, California, United States, 90033
        • USC/Norris Cancer Hospital
      • Palm Springs, California, United States, 92662
        • Comprehensive Cancer Center - Desert Regional Medical Center
      • Stanford, California, United States, 94305
        • Stanford University Division of Oncology
    • Colorado
      • Aurora, Colorado, United States, 80010
        • University of Colorado Cancer Center
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale University School of Medicine
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown University Medical Center
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana Oncology Hematology Consultants, A Division of AHN
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Markey Cancer Center, University of Kentucky Medical Center
    • Louisiana
      • Shreveport, Louisiana, United States, 71130
        • LSU Health Sciences Center, Feist Weiller Cancer Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana Farber Cancer Institute
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Cancer Center
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University School of Medicine in St. Louis
    • Nevada
      • Las Vegas, Nevada, United States, 89135
        • Nevada Cancer Institute
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • University of New Mexico Cancer Research and Treatment Center
    • New York
      • Buffalo, New York, United States, 14263
        • Roswell Park Cancer Institute
      • New York, New York, United States, 10021
        • Weill Cornell Cancer Care Center
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center, James P. Wilmot Cancer Center
      • Rochester, New York, United States, 14623
        • Interlakes Foundation, Inc.
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University School of Medicine
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • The Cleveland Clinic Foundation Taussig Cancer Center
    • Tennessee
      • Memphis, Tennessee, United States, 38138
        • The West Clinic/ACORN
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Research Institute
    • Texas
      • Arlington, Texas, United States, 76012
        • Arlington Cancer Center
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Cancer Center
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

ELIGIBILITY:

Key Inclusion Criteria

  • Documented B-cell Non-Hodgkin's Lymphoma
  • Small lymphocytic lymphoma (ALC < 5,000 cells/mm3)
  • Marginal zone B-cell lymphoma (nodal, extranodal, or splenic types)
  • Lymphoplasmacytic lymphoma
  • Follicular center lymphoma, follicular

Disease documented to be refractory to a full-course of the most recent rituximab therapy (single agent or combination)

  • At least 1 prior chemotherapy regimen and maximum of 3 prior chemotherapy regimens
  • Bidimensionally measurable disease (by CT scan) with at least one lesion measuring ≥ 2.0 cm in a single dimension

Key Exclusion Criteria

  • Patients who receive rituximab only as part of treatment with ibritumomab tiuxetan (Zevalin®) will not be eligible
  • History of prior high dose chemotherapy with allogeneic stem cell support (history of autologous stem cell support is permissible)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
bendamustine
Drug: Bendamustine HCl
Dose of 120 mg/m2 on Day 1 and Day 2 of each treatment cycle (every 21 days). Patients who are continuing to experience clinical benefit at Cycle 6, as assessed by the investigator, may receive up to 2 additional cycles, to a maximum of 8 cycles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assess the overall response rate (ORR = CR + CRu + PR) and duration of response (DR) to a regimen of bendamustine in patients who are refractory to rituximab therapy.
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
• assess the safety profile of Treanda in this patient population. • assess the duration of progression-free survival (PFS). • estimate the basic pharmacokinetic parameters • assess the effects of plasma concentrations
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cephalon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

July 1, 2007

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

August 18, 2005

First Submitted That Met QC Criteria

August 29, 2005

First Posted (Estimate)

August 31, 2005

Study Record Updates

Last Update Posted (Estimate)

May 9, 2014

Last Update Submitted That Met QC Criteria

May 8, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SDX-105-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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