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

NCT ID: NCT00069758

Last Updated: 2014-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-09-30

Study Completion Date

2007-04-30

Brief Summary

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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

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Conditions

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Non-Hodgkin's Lymphoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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SDX-105

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cephalon

INDUSTRY

Sponsor Role lead

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Comprehensive Cancer Center-Desert Regional Medical Center

Palm Springs, California, United States

Site Status

San Diego Cancer Center

Vista, California, United States

Site Status

Georgetown University Medical Center - Lombardi Cancer Center

Washington D.C., District of Columbia, United States

Site Status

Mountain States Tumor Institute

Boise, Idaho, United States

Site Status

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Site Status

The Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Site Status

University of Rochester Medical Center

Rochester, New York, United States

Site Status

The Sarah Cannon Cancer Center

Nashville, Tennessee, United States

Site Status

Southwest Regional Cancer Center

Austin, Texas, United States

Site Status

MD Anderson Cancer Center

Houston, Texas, United States

Site Status

University of Virginia Medical Center

Charlottesville, Virginia, United States

Site Status

Queen Elizabeth Health Sciences Centre

Halifax, Nova Scotia, Canada

Site Status

The Ottawa Hospital - General Campus

Ottawa, Ontario, Canada

Site Status

Toronto Sunnybrook Regional Cancer Centre

Toronto, Ontario, Canada

Site Status

CHA Hopital Enfant-Jesus

Québec, Quebec, Canada

Site Status

Countries

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United States Canada

Other Identifiers

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SDX-105-01

Identifier Type: -

Identifier Source: org_study_id

NCT00085033

Identifier Type: -

Identifier Source: nct_alias

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