Ignite Creation Date:
2025-12-24 @ 12:38 PM
Ignite Modification Date:
2025-12-27 @ 10:00 PM
Study NCT ID:
NCT00577161
Status:
WITHDRAWN
Last Update Posted:
2020-10-05
First Post:
2007-12-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fludarabine, Pixantrone and Rituximab vs Fludarabine and Rituximab forRelapsed or Refractory Indolent NHL
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C024352', 'term': 'fludarabine'}, {'id': 'D000069283', 'term': 'Rituximab'}, {'id': 'C086548', 'term': 'pixantrone'}], '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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'closed to enrollment', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-02', 'studyFirstSubmitDate': '2007-12-17', 'studyFirstSubmitQcDate': '2007-12-17', 'lastUpdatePostDateStruct': {'date': '2020-10-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-12-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'progression-free survival', 'timeFrame': 'day 64-71'}], 'secondaryOutcomes': [{'measure': 'response rate, survival, safety', 'timeFrame': 'every 21 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['pixantrone', 'NHL', 'rituximab', 'fludarabine'], 'conditions': ["Non-Hodgkin's Lymphoma"]}, 'descriptionModule': {'briefSummary': "BBR 2778 is a novel aza-anthracenedione that has activity in experimental tumors and reduced delayed cardiotoxicity in animal models compared to reference standards. This cytotoxic agent has structural similarities to mitoxantrone as well as general similarities to anthracyclines (such as the tricyclic central quinoid chromophore7).\n\nThis phase III study will compare the efficacy and safety of the combination BBR 2778, fludarabine, and rituximab with the combination fludarabine and rituximab in patients with relapsed or refractory indolent non-Hodgkin's lymphoma."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\n1. Histologically confirmed relapsed or refractory indolent non-Hodgkin's lymphoma (NHL)\n2. Any stage (Ann Arbor staging, Appendix 15.7), with or without B symptoms\n3. CD 20+ lymphoma (confirmed by immunochemistry)\n4. Measurable disease.\n5. Atleast 1 prior therapy.\n6. Age ≥ 18 years\n7. Life expectancy of at least 3 months\n8. ECOG performance status (PS) of 0 or 1\n9. Adequate cardiac function defined as LVEF ≥ 50% by MUGA scan\n10. Adequate renal function\n11. Adequate hepatic function\n12. Adequate bone marrow function\n13. Recovery from all acute toxicities from prior therapies (except alopecia and grade 1 peripheral neuropathy).\n\nExclusion Criteria\n\n1. Prior treatment with a cumulative dose of doxorubicin equivalent exceeding 450 mg/m2\n2. Radiotherapy, chemotherapy or other therapies for NHL within 4 weeks of treatment start\n3. Systemic corticosteroids to treat NHL within 5 days prior to first dose of study treatment.\n4. Radioimmunotherapy (RIT) within 3 months of treatment start\n5. Known hypersensitivity to the excipients or the study drugs that the patient will receive\n6. Known Type I hypersensitivity or anaphylactic reactions to murine proteins or to any component of rituximab\n7. Major thoracic and/or abdominal surgery in the preceding 4 weeks, from which the patient has not fully recovered (patients who have had minor surgery and one week's recovery period may be enrolled)\n8. HIV-related lymphoma\n9. Active CNS involvement\n10. Clinically significant cardiovascular abnormalities\n11. Serious (NCI CTCAE grade 3-4) intercurrent infection at randomization, infection requiring oral antibiotics, or deep-seated or systemic mycotic infections.\n12. Investigational study drug within 30 days before randomization. Patient must have recovered from all side effects of other investigational therapy.\n13. Clinical symptoms suggesting unresolved HIV, HBV or HCV infection. .\n14. History of another malignancy except: curatively treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in remission, or any other cancer from which the patient has been disease-free for 5 years\n15. Pregnant or lactating women\n16. Potentially fertile men and women and their sexual partners not willing to use adequate contraception as defined by the Investigator during the study and for 6 months after the last day of study drug administration"}, 'identificationModule': {'nctId': 'NCT00577161', 'briefTitle': 'Fludarabine, Pixantrone and Rituximab vs Fludarabine and Rituximab forRelapsed or Refractory Indolent NHL', 'organization': {'class': 'INDUSTRY', 'fullName': 'CTI BioPharma'}, 'officialTitle': "Fludarabine, BBR 2778 (Pixantrone) and Rituximab (FP-R) vs Fludarabine and Rituximab (F-R) for Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma", 'orgStudyIdInfo': {'id': 'PIX303'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Comparator', 'description': 'fludarabine and rituximab', 'interventionNames': ['Drug: fludarabine and rituximab']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'fludarabine, rituximab, pixantrone', 'interventionNames': ['Drug: fludarabine, rituximab, pixantrone']}], 'interventions': [{'name': 'fludarabine and rituximab', 'type': 'DRUG', 'description': 'days 1 to 4 of six 28-day cycles rituximab 375 mg/m2 fludarabine 25 mg/m2', 'armGroupLabels': ['Comparator']}, {'name': 'fludarabine, rituximab, pixantrone', 'type': 'DRUG', 'description': 'days 1 to 4 of six 28-day cycles rituximab 375 mg/m2 fludarabine 25 mg/m2 pixantrone 120 mg/m2 day 2 only', 'armGroupLabels': ['Experimental']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35661', 'city': 'Muscle Shoals', 'state': 'Alabama', 'country': 'United States', 'facility': 'Northwest Alabama Cancer Center', 'geoPoint': {'lat': 34.74481, 'lon': -87.66753}}, {'zip': '93030', 'city': 'Oxnard', 'state': 'California', 'country': 'United States', 'facility': 'Ventura County Hematology Oncology Specialist', 'geoPoint': {'lat': 34.1975, 'lon': -119.17705}}, {'zip': '65109', 'city': 'Jefferson City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Capitol Comprehensive Cancer Care', 'geoPoint': {'lat': 38.5767, 'lon': -92.17352}}, {'zip': '64118', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Heartland Hematology Oncology Associates', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '12208', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'Cancer Care Center', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '14623', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Interlakes Foundation, Inc.', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '43235', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Hematology Oncology Consultants', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '84403', 'city': 'Ogden', 'state': 'Utah', 'country': 'United States', 'facility': 'Utah Hematology Oncology, P.C.', 'geoPoint': {'lat': 41.223, 'lon': -111.97383}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CTI BioPharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}