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A Multi-Center Phase II Study to Investigate the Safety and Activity of SDX-105 (Bendamustine) in Patients With Indolent Non-Hodgkin's Lymphoma (NHL) Who Are Refractory to Rituximab


Phase 2
18 Years
N/A
Not Enrolling
Both
Non-Hodgkin's Lymphoma

Thank you

Trial Information

A Multi-Center Phase II Study to Investigate the Safety and Activity of SDX-105 (Bendamustine) in Patients With Indolent Non-Hodgkin's Lymphoma (NHL) Who Are Refractory to Rituximab


Inclusion Criteria:



- Documented indolent or transformed B-Cell NHL indolent NHL: follicular B-Cell
lymphoma, diffuse small lymphocytic lymphoma, lymphoplasmacytic lymphoma, marginal
zone lymphoma

- Documented refractory disease to rituximab therapy, given as a single agent or in
combination (defined as no response, or progression within 6 months of completing
rituximab treatment.)

- Age of at least 18 years at Screening Visit (Site specific requirement may differ)

Exclusion Criteria:

- Previous chemotherapy or immunotherapy within 3 weeks prior to entering the study (6
weeks for nitrosoureas or mitomycin) or failure to recover from adverse events due to
any agents administered previously.

- Use of investigational agents within 28 days of study

- History of prior high dose chemotherapy with allogeneic stem cell support

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

Authority:

United States: Food and Drug Administration

Study ID:

SDX-105-01

NCT ID:

NCT00069758

Start Date:

September 2003

Completion Date:

April 2007

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • NHL, indolent NHL, non-Hodgkin's lymphoma, lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

MD Anderson Cancer CenterHouston, Texas  77030-4096
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
University of Rochester Medical CenterRochester, New York  14642
Mountain States Tumor InstituteBoise, Idaho  83712
Southwest Regional Cancer CenterAustin, Texas  78705
University of Alabama at BirminghamBirmingham, Alabama  35294-3300
Dana Farber Cancer InstituteBoston, Massachusetts  02115
The Sarah Cannon Cancer CenterNashville, Tennessee  37203
San Diego Cancer CenterVista, California  92083
The Cancer Institute of New JerseyNew Brunswick, New Jersey  08901
Comprehensive Cancer Center-Desert Regional Medical CenterPalm Springs, California  92262
Georgetown University Medical Center - Lombardi Cancer CenterWashington, District of Columbia  20007
University of Virginia Medical CenterCharlottesville, Virginia  22908