Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-27 @ 11:31 PM
Study NCT ID:
NCT00086034
Status:
COMPLETED
Last Update Posted:
2007-05-15
First Post:
2004-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Motexafin Gadolinium for the Treatment of Non-Hodgkin's Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}], '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': 'C437683', 'term': 'motexafin gadolinium'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'statusVerifiedDate': '2007-05', 'lastUpdateSubmitDate': '2007-05-11', 'studyFirstSubmitDate': '2004-06-21', 'studyFirstSubmitQcDate': '2004-06-22', 'lastUpdatePostDateStruct': {'date': '2007-05-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-06-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical response rate'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival'}, {'measure': 'Duration of clinical response'}, {'measure': 'Safety and tolerability'}]}, 'conditionsModule': {'keywords': ['Lymphoma', "Non-Hodgkin's Lymphoma", 'Indolent lymphoma', 'Relapsed lymphoma', 'Refractory lymphoma', 'Motexafin gadolinium'], 'conditions': ['Lymphoma', "Non-Hodgkin's Lymphoma"]}, 'descriptionModule': {'briefSummary': "The primary purpose of this study is to find out if motexafin gadolinium may be an effective treatment for patients with non-Hodgkin's lymphoma (NHL). Secondly, the safety and side effects of motexafin gadolinium will be evaluated."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥ 18 years old\n* Refractory or relapsed indolent NHL. Eligible WHO histologies include follicular NHL (Grades 1, 2, and 3); marginal zone nodal; marginal zone splenic; and mucosa-associated lymphoid tissue (MALT) types\n* Failed ≥ 1 previous regimens, one of which must have contained rituximab as either a single agent or in combination with chemotherapy\n* ECOG performance status score either 0 or 1\n* Willing and able to provide written informed consent\n\nExclusion Criteria:\n\nLaboratory values of:\n\n* Platelet count \\< 50,000/µL\n* AST or ALT \\> 2 x the upper limit of normal (ULN)\n* Total bilirubin \\> 2 x ULN\n* Creatinine \\> 2.0 mg/dL\n\nand\n\n* Greater than three prior regimens (where a regimen is defined as a treatment for NHL given after disease progression)\n* Uncontrolled hypertension\n* Known history of porphyria, G6PD deficiency, HIV'}, 'identificationModule': {'nctId': 'NCT00086034', 'briefTitle': "Study of Motexafin Gadolinium for the Treatment of Non-Hodgkin's Lymphoma", 'organization': {'class': 'INDUSTRY', 'fullName': 'Pharmacyclics LLC.'}, 'officialTitle': "Phase II Trial of Motexafin Gadolinium (MGd) in Patients With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma", 'orgStudyIdInfo': {'id': 'PCYC-0221'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Motexafin gadolinium', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92121', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '21231', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Brad Kahl, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin, Madison'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pharmacyclics LLC.', 'class': 'INDUSTRY'}}}}