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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Non-Hodgkin's Lymphoma

Thank you

Trial Information

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

Inclusion 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)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome 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.

Outcome Time Frame:

6 months

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

SDX-105-03

NCT ID:

NCT00139841

Start Date:

October 2005

Completion Date:

October 2009

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • Lymphoma, Non-Hodgkin
  • Rituximab Refractory
  • Rituximab Failure
  • Indolent Non-Hodgkins Lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

Arizona Cancer CenterTucson, Arizona  85724
Roswell Park Cancer InstituteBuffalo, New York  14263
University of Colorado Cancer CenterDenver, Colorado  80262
Rush University Medical CenterChicago, Illinois  60612-3824
University of New Mexico Cancer Research and Treatment CenterAlbuquerque, New Mexico  87131
Arlington Cancer CenterArlington, Texas  76012
University of Virginia Cancer CenterCharlottesville, Virginia  22908
Alta Bates Comprehensive Cancer CenterBerkeley, California  94704
Moores UCSD Cancer CenterLa Jolla, California  92093-0658
Henry Ford Health SystemDetroit, Michigan  48202
University of Michigan Cancer CenterAnn Arbor, Michigan  48109
Dana Farber Cancer InstituteBoston, Massachusetts  02115
Georgetown University Medical CenterWashington, District of Columbia  20007
University of Rochester Medical Center, James P. Wilmot Cancer CenterRochester, New York  14642
Yale University School Of MedicineNew Haven, Connecticut  06520
University of WisconsinMadison,, Wisconsin  53792-5666
Nevada Cancer InstituteLas Vegas, Nevada  89135
Sarah Cannon Research InstituteNashville, Tennessee  37203
University of Alabama BirminghamBirmingham, Alabama  35233
Tower Hematology and Oncology Medical GroupBeverly Hills, California  90211
USC/Norris Cancer HospitalLos Angeles, California  90033
Comprehensive Cancer Center - Desert Regional Medical CenterPalm Springs, California  92662
Stanford University Division of OncologyStanford, California  94305
Indiana Oncology Hematology Consultants, A Division of AHNIndianapolis, Indiana  46202
Markey Cancer Center, University of Kentucky Medical CenterLexington, Kentucky  40536
LSU Health Sciences Center, Feist Weiller Cancer CenterShreveport, Louisiana  71130
Washington University School of Medicine in St. LouisSt. Louis, Missouri  63110
Weill Cornell Cancer Care CenterNew York, New York  10021
Interlakes Foundation, Inc.Rochester, New York  14623
Duke University School of MedicineDurham, North Carolina  27710
The Cleveland Clinic Foundation Taussig Cancer CenterCleveland, Ohio  44195
The West Clinic/ACORNMemphis, Tennessee  38138