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

Sponsor:	Cephalon
Information provided by:	Cephalon
ClinicalTrials.gov Identifier:	NCT00139841

Purpose

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.

Condition	Intervention	Phase
Non-Hodgkin's Lymphoma	Drug: Bendamustine HCl	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lymphoma

Drug Information available for: Bendamustine Rituximab Bendamustine hydrochloride

U.S. FDA Resources

Further study details as provided by Cephalon:

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. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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 [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment:	103
Study Start Date:	October 2005
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00139841

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Locations

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

Sponsors and Collaborators

Cephalon

More Information

No publications provided

Responsible Party:	Cephalon ( Sponsor's Medical Expert )
Study ID Numbers:	SDX-105-03
Study First Received:	August 18, 2005
Last Updated:	June 24, 2008
ClinicalTrials.gov Identifier:	NCT00139841 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Cephalon:

Lymphoma, Non-Hodgkin
Rituximab Refractory
Rituximab Failure
Indolent Non-Hodgkins Lymphoma

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Immunoproliferative Disorders
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Rituximab
Antineoplastic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Lymphatic Diseases

Neoplasms
Therapeutic Uses
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Alkylating Agents
Lymphoma
Nitrogen Mustard Compounds
Bendamustine

ClinicalTrials.gov processed this record on November 25, 2009