Clinical trial NCT00139841: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-Hodgkin's Lymphoma
Keywords: Lymphoma, Non-Hodgkin
Rituximab Refractory
Rituximab Failure
Indolent Non-Hodgkins Lymphoma
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2005-08-31
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: 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.
timeFrame: 6 months
Secondary outcomes:
measure: • 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
timeFrame: 6 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Birmingham
state: Alabama
city: Tucson
country: United States
facility: Arizona Cancer Center
state: Arizona
city: Berkeley
country: United States
facility: Alta Bates Comprehensive Cancer Center
state: California
city: Beverly Hills
country: United States
facility: Tower Hematology and Oncology Medical Group
state: California
city: La Jolla
country: United States
facility: Moores UCSD Cancer Center
state: California
city: Los Angeles
country: United States
facility: USC/Norris Cancer Hospital
state: California
city: Palm Springs
country: United States
facility: Comprehensive Cancer Center - Desert Regional Medical Center
state: California
city: Stanford
country: United States
facility: Stanford University Division of Oncology
state: California
city: Aurora
country: United States
facility: University of Colorado Cancer Center
state: Colorado
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Washington
country: United States
facility: Georgetown University Medical Center
state: District of Columbia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: Indiana Oncology Hematology Consultants, A Division of AHN
state: Indiana
city: Lexington
country: United States
facility: Markey Cancer Center, University of Kentucky Medical Center
state: Kentucky
city: Shreveport
country: United States
facility: LSU Health Sciences Center, Feist Weiller Cancer Center
state: Louisiana
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Cancer Center
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: St. Louis
country: United States
facility: Washington University School of Medicine in St. Louis
state: Missouri
city: Las Vegas
country: United States
facility: Nevada Cancer Institute
state: Nevada
city: Albuquerque
country: United States
facility: University of New Mexico Cancer Research and Treatment Center
state: New Mexico
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: New York
country: United States
facility: Weill Cornell Cancer Care Center
state: New York
city: Rochester
country: United States
facility: Interlakes Foundation, Inc.
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center, James P. Wilmot Cancer Center
state: New York
city: Durham
country: United States
facility: Duke University School of Medicine
state: North Carolina
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation Taussig Cancer Center
state: Ohio
city: Memphis
country: United States
facility: The West Clinic/ACORN
state: Tennessee
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: Arlington
country: United States
facility: Arlington Cancer Center
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Cancer Center
state: Virginia
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Vancouver
country: Canada
facility: British Columbia Cancer Agency
state: British Columbia
city: Halifax
country: Canada
facility: Queen Elizabeth Health Sciences Centre
state: Nova Scotia
city: Ottawa
country: Canada
facility: Ottawa Hospital - General Campus
state: Ontario
city: Montreal
country: Canada
facility: Hopital Notre-Dame du CHUM
state: Quebec
city: Montreal
country: Canada
facility: Hopital du Sacre Couer de Montreal
state: Quebec
city: Saskatoon
country: Canada
facility: Saskatchewan Cancer Center Agency
state: Saskatchewan
city: San Juan
country: Puerto Rico
facility: Hospital Espanol Auxilio Mutuo, Auxilio Mutuo Cancer Center
Study officials:
References: