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

Phase 2

Completed

• Conditions: Non-Hodgkin's Lymphoma

• Registration Number: NCT00069758
• Lead Sponsor: Cephalon

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-09
• Study First Submitted: 2003-09-30
• Study First Submitted QC: 2003-10-01
• Study First Posted: 2003-10-02
• Primary Completion: 2007-04
• Study Completion: 2007-04
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-08
• Last Update Posted: 2014-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Trial Locations

Locations (17)

Southwest Regional Cancer Center; 🇺🇸 Austin, Texas, United States

San Diego Cancer Center; 🇺🇸 Vista, California, United States

CHA Hopital Enfant-Jesus; 🇨🇦 Quebec, Canada

The Ottawa Hospital - General Campus; 🇨🇦 Ottawa, Ontario, Canada

Comprehensive Cancer Center-Desert Regional Medical Center; 🇺🇸 Palm Springs, California, United States

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States

University of Virginia Medical Center; 🇺🇸 Charlottesville, Virginia, United States

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Mountain States Tumor Institute; 🇺🇸 Boise, Idaho, United States

The Cancer Institute of New Jersey; 🇺🇸 New Brunswick, New Jersey, United States

The Sarah Cannon Cancer Center; 🇺🇸 Nashville, Tennessee, United States

Queen Elizabeth Health Sciences Centre; 🇨🇦 Halifax, Nova Scotia, Canada

Toronto Sunnybrook Regional Cancer Centre; 🇨🇦 Toronto, Ontario, Canada

Georgetown University Medical Center - Lombardi Cancer Center; 🇺🇸 Washington, District of Columbia, United States

University of Michigan Comprehensive Cancer Center; 🇺🇸 Ann Arbor, Michigan, United States