Safety and Activity of SDX-105 (Bendamustine) in Patients With Rituximab Refractory Non-Hodgkin's Lymphoma

Non-Hodgkin's Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00069758
• Other study ID #: SDX-105-01
• Status: Completed
• Phase: Phase 2
• First received: September 30, 2003
• Last updated: May 8, 2014
• Start date: September 2003
• Est. completion date: April 2007

Study information

• Verified date: May 2014
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Summary: As this is an open label study, all patients will receive SDX-105 by 30-60 minute intravenous infusion on day 1 and day 2. Treatment will repeat every 21 days. Treatment can continue for up to one year in the absence of disease progression or unacceptable toxicity. Patients will be followed until disease progression.

Rationale: Drugs used in chemotherapy, such as SDX-105, use different ways to stop tumor cells from dividing so they stop growing or die.

Purpose: This study will evaluate the effectiveness and safety in non-Hodgkin's lymphoma in patients who are refractory to Rituxan.

Other known NCT identifiers

• NCT00085033

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Non-Hodgkin's Lymphoma

Intervention

Drug:
• SDX-105

Locations

Country	Name	City	State
Canada	Queen Elizabeth Health Sciences Centre	Halifax	Nova Scotia
Canada	The Ottawa Hospital - General Campus	Ottawa	Ontario
Canada	CHA Hopital Enfant-Jesus	Quebec
Canada	Toronto Sunnybrook Regional Cancer Centre	Toronto	Ontario
United States	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan
United States	Southwest Regional Cancer Center	Austin	Texas
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Mountain States Tumor Institute	Boise	Idaho
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	University of Virginia Medical Center	Charlottesville	Virginia
United States	MD Anderson Cancer Center	Houston	Texas
United States	The Sarah Cannon Cancer Center	Nashville	Tennessee
United States	The Cancer Institute of New Jersey	New Brunswick	New Jersey
United States	Comprehensive Cancer Center-Desert Regional Medical Center	Palm Springs	California
United States	University of Rochester Medical Center	Rochester	New York
United States	San Diego Cancer Center	Vista	California
United States	Georgetown University Medical Center - Lombardi Cancer Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Cephalon

Countries where clinical trial is conducted

United States,  Canada,