Ignite Creation Date:
2025-12-24 @ 3:32 PM
Ignite Modification Date:
2025-12-25 @ 1:50 PM
Study NCT ID:
NCT01007292
Status:
COMPLETED
Last Update Posted:
2015-10-19
First Post:
2009-09-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of YM155 Plus Rituximab in Subjects With Non-Hodgkin's Lymphoma Who Have Received Prior Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D008223', 'term': 'Lymphoma'}, {'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'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C523798', 'term': 'sepantronium'}, {'id': 'D000069283', 'term': 'Rituximab'}], 'ancestors': [{'id': 'D058846', 'term': 'Antibodies, Monoclonal, Murine-Derived'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'dispFirstSubmitDate': '2015-08-20', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-29', 'studyFirstSubmitDate': '2009-09-24', 'dispFirstSubmitQcDate': '2015-08-20', 'studyFirstSubmitQcDate': '2009-11-02', 'dispFirstPostDateStruct': {'date': '2015-09-04', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-10-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective response rate (Confirmed Complete Remission +Confirmed Partial Remission)', 'timeFrame': 'After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment'}], 'secondaryOutcomes': [{'measure': 'Confirmed Complete remission rate', 'timeFrame': 'After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment'}, {'measure': 'Confirmed Partial remission rate', 'timeFrame': 'After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment'}, {'measure': 'Time to response', 'timeFrame': 'After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment'}, {'measure': 'Duration of response', 'timeFrame': 'After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment'}, {'measure': 'Clinical benefit rate', 'timeFrame': 'After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment'}, {'measure': 'Progression-free survival', 'timeFrame': 'After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment'}, {'measure': 'Overall survival', 'timeFrame': '1 year after the last subject completes treatment'}, {'measure': 'Safety assessed by recording of adverse events, physical examinations, vital signs, laboratory assessments and electrocardiograms (ECGs)', 'timeFrame': 'After the last non-progressing subject receives 8 cycles of treatment or discontinues the treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ["Non-Hodgkin's Lymphoma", 'relapsed', 'CD20-Positive', 'YM155'], 'conditions': ["Non-Hodgkin's Lymphoma"]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to evaluate response rate, survival, safety and tolerability of YM155 given in combination with rituximab in subjects with Non-Hodgkin's Lymphoma.", 'detailedDescription': 'This is an outpatient study. All subjects enrolled in this study will receive YM155 and rituximab given during 14 day cycles. Each subject will be assessed at the end of each cycle to determine if he or she may continue to the next cycle. Each subject will be eligible to continue receiving the combination regimen in this study until one of the discontinuation criteria is met.\n\nIf a subject discontinues treatment without progressive disease (PD) that subject will complete follow-up visits every 12 weeks for 1 year or until initiating another systemic anti-lymphoma treatment, exhibiting PD, or death.\n\nEach subject will be contacted by the study site every 12 weeks for survival following the End of Treatment Visit. The contacts will continue until death or for no more than 1 year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any stage, histologically confirmed CD20-positive primary or transformed diffuse large B cell lymphoma (DLBCL)or grade 3 follicular lymphoma (FL)\n* Ineligible for or have previously received an autologous stem cell transplant (ASCT)\n* Relapsed following receipt of the last dose of systemic chemotherapy or ASCT\n* At least one prior chemotherapy regimen. Prior chemotherapy regimen must have contained anthracycline (unless contraindicated)\n* If the subject is female, she must be non-pregnant and non-lactating at the Baseline Visit. All sexually active males and females of childbearing potential must agree to use an adequate method of contraception throughout the study period\n* Eastern Cooperative Oncology Group (ECOG) performance status \\</= 1\n\nExclusion Criteria:\n\n* Use of any standard/experimental anti-lymphoma drug therapy within 21 days of the Baseline Visit\n* Use of systemic steroids within 5 days of the Baseline Visit (except for the purposes of pre-medication prior to study regimen treatment)\n* Prior allogeneic stem cell transplant (SCT)\n* The subject has been previously treated with YM155\n* The subject has known human immunodeficiency virus (HIV), hepatitis B surface antigen, or hepatitis C antibody\n* The subject has received other investigational therapy or procedures within 21 days prior to the first study drug administration'}, 'identificationModule': {'nctId': 'NCT01007292', 'briefTitle': "A Study of YM155 Plus Rituximab in Subjects With Non-Hodgkin's Lymphoma Who Have Received Prior Treatment", 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': "A Phase II, Multicenter, Open-Label Study Of YM155 Plus Rituximab In Previously Treated Subjects With CD20-Positive B Cell Non-Hodgkin's Lymphoma Who Are Ineligible For Or Have Previously Received An Autologous Stem Cell Transplant", 'orgStudyIdInfo': {'id': '155-CL-031'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'YM155 plus rituximab', 'interventionNames': ['Drug: YM155', 'Biological: Rituximab']}], 'interventions': [{'name': 'YM155', 'type': 'DRUG', 'description': 'intravenous infusion', 'armGroupLabels': ['YM155 plus rituximab']}, {'name': 'Rituximab', 'type': 'BIOLOGICAL', 'otherNames': ['Rituxan', 'Mabthera'], 'description': 'intravenous infusion', 'armGroupLabels': ['YM155 plus rituximab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31904', 'city': 'Columbus', 'state': 'Georgia', 'country': 'United States', 'facility': 'Site US2778 John B. Amos Cancer Center', 'geoPoint': {'lat': 32.46098, 'lon': -84.98771}}, {'zip': '60153', 'city': 'Maywood', 'state': 'Illinois', 'country': 'United States', 'facility': 'Site US55 Loyola University Hospital - Maywood', 'geoPoint': {'lat': 41.8792, 'lon': -87.84312}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Site US9 Mount Sinai School of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '28204', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Site US2802 Mecklenburg Medical Group', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '44718', 'city': 'Canton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Site US2149 Gabrail Cancer Center Research', 'geoPoint': {'lat': 40.79895, 'lon': -81.37845}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Site US402 University of Texas Health Science Center - San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '33076', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Site FR1926 Institut Bergonie', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '06189', 'city': 'Nice', 'country': 'France', 'facility': 'Site FR2700 Centre Antoine Lacassagne', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '75475', 'city': 'Paris', 'country': 'France', 'facility': 'Site FR476 Hopital Saint Louis', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '76038', 'city': 'Rouen', 'country': 'France', 'facility': 'Site FR1889 Centre de Lutte Contre le Cancer - Centre Henri Becquerel', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '37044', 'city': 'Tours', 'country': 'France', 'facility': 'Site FR1897 Hopital Bretonneau', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}, {'zip': '08003', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Site ES1349 Hospital del Mar', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28034', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Site ES1339 Hospital Universitario Ramon y Cajal', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28050', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Site ES2967 Hosptial Universitario Madrid Sanchinarro', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '37007', 'city': 'Salamanca', 'country': 'Spain', 'facility': 'Site ES1346 Hospital Universitario de Salamanca', 'geoPoint': {'lat': 40.96882, 'lon': -5.66388}}, {'zip': 'CB2 0QQ', 'city': 'Cambridge', 'country': 'United Kingdom', 'facility': 'Site GB2702 Addenbrookes Hospital', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'zip': 'SW17 0QT', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Site GB1928 St. Georges Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'M20 4BX', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Site GB2624 The Christie NHS Foundation Trust', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'zip': 'OX3 7LJ', 'city': 'Oxford', 'country': 'United Kingdom', 'facility': 'Site GB1903 Oxford Radcliffe Hospital', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}], 'overallOfficials': [{'name': 'Senior Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Astellas Pharma Global Development'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}