Safety and Activity of SDX-105 (Bendamustine) in Patients With Rituximab Refractory Non-Hodgkin's Lymphoma
This study has been completed.
Sponsor:
Cephalon
Information provided by:
Cephalon
ClinicalTrials.gov Identifier:
NCT00069758
First received: September 30, 2003
Last updated: November 9, 2007
Last verified: November 2007
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-Hodgkin's Lymphoma |
Drug: SDX-105 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Cephalon:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00069758
Locations
| United States, Alabama | |
| University of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35294-3300 | |
| United States, California | |
| Comprehensive Cancer Center-Desert Regional Medical Center | |
| Palm Springs, California, United States, 92262 | |
| San Diego Cancer Center | |
| Vista, California, United States, 92083 | |
| United States, District of Columbia | |
| Georgetown University Medical Center - Lombardi Cancer Center | |
| Washington, District of Columbia, United States, 20007 | |
| United States, Idaho | |
| Mountain States Tumor Institute | |
| Boise, Idaho, United States, 83712 | |
| United States, Massachusetts | |
| Dana Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Michigan | |
| University of Michigan Comprehensive Cancer Center | |
| Ann Arbor, Michigan, United States, 48109 | |
| United States, New Jersey | |
| The Cancer Institute of New Jersey | |
| New Brunswick, New Jersey, United States, 08901 | |
| United States, New York | |
| University of Rochester Medical Center | |
| Rochester, New York, United States, 14642 | |
| United States, Tennessee | |
| The Sarah Cannon Cancer Center | |
| Nashville, Tennessee, United States, 37203 | |
| United States, Texas | |
| Southwest Regional Cancer Center | |
| Austin, Texas, United States, 78705 | |
| MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| United States, Virginia | |
| University of Virginia Medical Center | |
| Charlottesville, Virginia, United States, 22908 | |
| Canada, Nova Scotia | |
| Queen Elizabeth Health Sciences Centre | |
| Halifax, Nova Scotia, Canada, B3H 2Y9 | |
| Canada, Ontario | |
| The Ottawa Hospital - General Campus | |
| Ottawa, Ontario, Canada, K1H 8L6 | |
| Toronto Sunnybrook Regional Cancer Centre | |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Canada | |
| CHA Hopital Enfant-Jesus | |
| Quebec, Canada, G1J 1Z4 | |
Sponsors and Collaborators
Cephalon
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00069758 History of Changes |
| Obsolete Identifiers: | NCT00085033 |
| Other Study ID Numbers: | SDX-105-01 |
| Study First Received: | September 30, 2003 |
| Last Updated: | November 9, 2007 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Cephalon:
|
NHL, indolent NHL, non-Hodgkin's lymphoma, lymphoma |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
Bendamustine Rituximab Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents |
ClinicalTrials.gov processed this record on May 23, 2013