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

Primary Purpose

Non-Hodgkin's Lymphoma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Bendamustine HCl
Sponsored by
Cephalon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Hodgkin's Lymphoma focused on measuring Lymphoma, Non-Hodgkin, Rituximab Refractory, Rituximab Failure, Indolent Non-Hodgkins Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of Alabama Birmingham
  • Arizona Cancer Center
  • Alta Bates Comprehensive Cancer Center
  • Tower Hematology and Oncology Medical Group
  • Moores UCSD Cancer Center
  • USC/Norris Cancer Hospital
  • Comprehensive Cancer Center - Desert Regional Medical Center
  • Stanford University Division of Oncology
  • University of Colorado Cancer Center
  • Yale University School of Medicine
  • Georgetown University Medical Center
  • Rush University Medical Center
  • Indiana Oncology Hematology Consultants, A Division of AHN
  • Markey Cancer Center, University of Kentucky Medical Center
  • LSU Health Sciences Center, Feist Weiller Cancer Center
  • Dana Farber Cancer Institute
  • University of Michigan Cancer Center
  • Henry Ford Health System
  • Washington University School of Medicine in St. Louis
  • Nevada Cancer Institute
  • University of New Mexico Cancer Research and Treatment Center
  • Roswell Park Cancer Institute
  • Weill Cornell Cancer Care Center
  • Interlakes Foundation, Inc.
  • University of Rochester Medical Center, James P. Wilmot Cancer Center
  • Duke University School of Medicine
  • The Cleveland Clinic Foundation Taussig Cancer Center
  • The West Clinic/ACORN
  • Sarah Cannon Research Institute
  • Arlington Cancer Center
  • University of Virginia Cancer Center
  • University of Wisconsin
  • Cross Cancer Institute
  • British Columbia Cancer Agency
  • Queen Elizabeth Health Sciences Centre
  • Ottawa Hospital - General Campus
  • Hopital Notre-Dame du CHUM
  • Hopital du Sacre Couer de Montreal
  • Saskatchewan Cancer Center Agency
  • Hospital Espanol Auxilio Mutuo, Auxilio Mutuo Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

bendamustine

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

• 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

Full Information

First Posted
August 18, 2005
Last Updated
May 8, 2014
Sponsor
Cephalon
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1. Study Identification

Unique Protocol Identification Number
NCT00139841
Brief Title
Safety and Efficacy of Treanda™ (Bendamustine HCl) in Patients With Indolent Non-Hodgkin's Lymphoma (NHL) Who Are Refractory to Rituximab
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cephalon

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin's Lymphoma
Keywords
Lymphoma, Non-Hodgkin, Rituximab Refractory, Rituximab Failure, Indolent Non-Hodgkins Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
103 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
bendamustine
Intervention Type
Drug
Intervention Name(s)
Bendamustine HCl
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
• 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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
University of Alabama Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Arizona Cancer Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Alta Bates Comprehensive Cancer Center
City
Berkeley
State/Province
California
ZIP/Postal Code
94704
Country
United States
Facility Name
Tower Hematology and Oncology Medical Group
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Moores UCSD Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
USC/Norris Cancer Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Comprehensive Cancer Center - Desert Regional Medical Center
City
Palm Springs
State/Province
California
ZIP/Postal Code
92662
Country
United States
Facility Name
Stanford University Division of Oncology
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
University of Colorado Cancer Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80010
Country
United States
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Indiana Oncology Hematology Consultants, A Division of AHN
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Markey Cancer Center, University of Kentucky Medical Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
LSU Health Sciences Center, Feist Weiller Cancer Center
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71130
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
University of Michigan Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Washington University School of Medicine in St. Louis
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Nevada Cancer Institute
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89135
Country
United States
Facility Name
University of New Mexico Cancer Research and Treatment Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Weill Cornell Cancer Care Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Interlakes Foundation, Inc.
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Facility Name
University of Rochester Medical Center, James P. Wilmot Cancer Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Duke University School of Medicine
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
The Cleveland Clinic Foundation Taussig Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
The West Clinic/ACORN
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Arlington Cancer Center
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
University of Virginia Cancer Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
British Columbia Cancer Agency
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
Queen Elizabeth Health Sciences Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Facility Name
Ottawa Hospital - General Campus
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
KIH8L6
Country
Canada
Facility Name
Hopital Notre-Dame du CHUM
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2: 4M1
Country
Canada
Facility Name
Hopital du Sacre Couer de Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Facility Name
Saskatchewan Cancer Center Agency
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 4H4
Country
Canada
Facility Name
Hospital Espanol Auxilio Mutuo, Auxilio Mutuo Cancer Center
City
San Juan
ZIP/Postal Code
00919
Country
Puerto Rico

12. IPD Sharing Statement

Learn more about this trial

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

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