Ignite Creation Date:
2025-12-25 @ 12:09 AM
Ignite Modification Date:
2025-12-25 @ 10:09 PM
Study NCT ID:
NCT00069758
Status:
COMPLETED
Last Update Posted:
2014-05-09
First Post:
2003-09-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Activity of SDX-105 (Bendamustine) in Patients With Rituximab Refractory Non-Hodgkin's Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069461', 'term': 'Bendamustine Hydrochloride'}], 'ancestors': [{'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-09'}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-08', 'studyFirstSubmitDate': '2003-09-30', 'studyFirstSubmitQcDate': '2003-10-01', 'lastUpdatePostDateStruct': {'date': '2014-05-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-10-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ["NHL, indolent NHL, non-Hodgkin's lymphoma, lymphoma"], 'conditions': ["Non-Hodgkin's Lymphoma"]}, 'descriptionModule': {'briefSummary': "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.\n\nRationale: Drugs used in chemotherapy, such as SDX-105, use different ways to stop tumor cells from dividing so they stop growing or die.\n\nPurpose: This study will evaluate the effectiveness and safety in non-Hodgkin's lymphoma in patients who are refractory to Rituxan."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Documented indolent or transformed B-Cell NHL indolent NHL: follicular B-Cell lymphoma, diffuse small lymphocytic lymphoma, lymphoplasmacytic lymphoma, marginal zone lymphoma\n* 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.)\n* Age of at least 18 years at Screening Visit (Site specific requirement may differ)\n\nExclusion Criteria:\n\n* 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.\n* Use of investigational agents within 28 days of study\n* History of prior high dose chemotherapy with allogeneic stem cell support'}, 'identificationModule': {'nctId': 'NCT00069758', 'briefTitle': "Safety and Activity of SDX-105 (Bendamustine) in Patients With Rituximab Refractory Non-Hodgkin's Lymphoma", 'nctIdAliases': ['NCT00085033'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Teva Branded Pharmaceutical Products R&D, Inc.'}, 'officialTitle': "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", 'orgStudyIdInfo': {'id': 'SDX-105-01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'SDX-105', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294-3300', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '92262', 'city': 'Palm Springs', 'state': 'California', 'country': 'United States', 'facility': 'Comprehensive Cancer Center-Desert Regional Medical Center', 'geoPoint': {'lat': 33.8303, 'lon': -116.54529}}, {'zip': '92083', 'city': 'Vista', 'state': 'California', 'country': 'United States', 'facility': 'San Diego Cancer Center', 'geoPoint': {'lat': 33.20004, 'lon': -117.24254}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Georgetown University Medical Center - Lombardi Cancer Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '83712', 'city': 'Boise', 'state': 'Idaho', 'country': 'United States', 'facility': 'Mountain States Tumor Institute', 'geoPoint': {'lat': 43.6135, 'lon': -116.20345}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Comprehensive Cancer Center', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '08901', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'The Cancer Institute of New Jersey', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester Medical Center', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'The Sarah Cannon Cancer Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Southwest Regional Cancer Center', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia Medical Center', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': 'B3H 2Y9', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'Queen Elizabeth Health Sciences Centre', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': 'K1H 8L6', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Ottawa Hospital - General Campus', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Toronto Sunnybrook Regional Cancer Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'G1J 1Z4', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'CHA Hopital Enfant-Jesus', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cephalon', 'class': 'INDUSTRY'}}}}