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Completed Phase 2 Interventional

SDX-105 in Combination With Rituxan for Patients With Relapsed Indolent or Mantle Cell Non-Hodgkin's Lymphoma (NHL)

ClinicalTrials.gov ID: NCT00076349

Public ClinicalTrials.gov record NCT00076349. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 1, 2026, 7:09 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Multi-Center Phase II Study to Investigate the Safety and Activity of SDX-105 (Bendamustine) in Combination With Rituximab in Patients With Relapsed Indolent or Mantle Cell Non-Hodgkin's Lymphoma (NHL)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

SUMMARY: This is an open label study combining Rituxan and SDX-105. Rituxan will be given on day 1 followed by a 30-60 minute intravenous infusion of SDX-105 on day 2 and day 3. Treatment will repeat every 21 days (a cycle). Treatment can continue for up to 6 cycles (about 4 months) if tumor status improves and there are no unacceptable side effects. Patients will be followed for up to 2 years or until disease progression. RATIONALE: Rituxan has been shown to increase the sensitivity of cells to chemotherapy. The combination of SDX-105 and Rituxan has been effective in both the laboratory and in a recent clinical study with Non-Hodgkin's lymphoma patients. PURPOSE: This study will evaluate the safety and effectiveness of SDX-105 plus Rituxan in patients with Non-Hodgkin's lymphoma who have relapsed after taking Rituxan.

Study identification

NCT ID
NCT00076349
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Cephalon
Industry
Enrollment
66 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 31, 2004
Primary completion
Nov 30, 2005
Completion
Feb 29, 2008
Last update posted
May 8, 2014

2004 – 2008

United States locations

U.S. sites
25
U.S. states
16
U.S. cities
25
Facility City State ZIP Site status
Alaska Cancer Research and Education Center Anchorage Alaska 99508
Bay Area Cancer Research Group Concord California 94520
Wilshire Oncology Medical Group La Verne California 91750
USC/Kenneth Norris Jr. Cancer Hospital and Research Institute Los Angeles California 90033
San Diego Cancer Center Vista California 92081
Hematology Oncology, P.C. Carl and Dorothy Bennett Cancer Center Stamford Connecticut 06902-3628
Georgetown University Medical Center - Lombardi Cancer Center Washington D.C. District of Columbia 20007
Pasco Hernando Oncology New Port Richey Florida 34652
John B. Amos Cancer Center Columbus Georgia 31902
Suburban Hematology & Oncology Associates Lawrenceville Georgia 30045
Georgia Oncology Partners Research and Education Foundation Macon Georgia 31201
Northern Indiana Cancer Research Consortium South Bend Indiana 46601
Oncology and Hematology Metairie Louisiana 70006-2921
LSU Health Sciences Center Shreveport Louisiana 71103
Beth Israel/Deaconess Medical Center Boston Massachusetts 02215
University of Michigan Comprehensive Cancer Center Ann Arbor Michigan 48109
Hubert H. Humphrey Cancer Center Robbinsdale Minnesota 55422
The Cancer Institute of New Jersey New Brunswick New Jersey 08903
Arena Oncology Associates Great Neck New York 11021
Long Island Jewish Medical Center New Hyde Park New York 11040
Upstate NY Cancer Research & Education Foundation, Inc. - Interlakes Oncology/Hematology Rochester New York 14623
ACORN - West Cancer Center Memphis Tennessee 38120
Southwest Regional Cancer Center Austin Texas 78705
Baylor University Medical Center Dallas Texas 75246
Univ. of Virginia Health System-Cancer Center Clinical Trials Office Charlottesville Virginia 22908

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 9 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00076349, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 8, 2014 · Synced Sep 1, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00076349 live on ClinicalTrials.gov.

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