Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2025-12-25 @ 8:19 PM
Study NCT ID:
NCT00901069
Status:
COMPLETED
Last Update Posted:
2016-10-17
First Post:
2009-05-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Azacitidine With Rituximab, Vincristine, and Cyclophosphamide in Refractory Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D006689', 'term': 'Hodgkin Disease'}, {'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': 'D001374', 'term': 'Azacitidine'}, {'id': 'D000069283', 'term': 'Rituximab'}, {'id': 'D014750', 'term': 'Vincristine'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}], 'ancestors': [{'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}, {'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'}, {'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-13', 'studyFirstSubmitDate': '2009-05-11', 'studyFirstSubmitQcDate': '2009-05-12', 'lastUpdatePostDateStruct': {'date': '2016-10-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine the maximal tolerated dose (MTD) of azacitidine in combination with rituximab, vincristine, and cyclophosphamide in patients with lymphoma', 'timeFrame': 'Eight 21 day cycles'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Lymphoma', 'Hodgkin Disease', 'Lymphoma, Non-Hodgkin']}, 'descriptionModule': {'briefSummary': 'This is a phase I, prospective, open label, dose escalation study of azacitidine in combination with rituximab, vincristine, and cyclophosphamide for the treatment of refractory lymphoma. The investigators expect to enroll 12-24 patients in this trial over a 2 year accrual period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient or their authorized legally acceptable representative must consent to be in the study and must have signed and dated an approved consent form which conforms to federal and institutional guidelines.\n2. Age ≥ 18 years and without a maximum age.\n3. All patients of reproductive potential should not plan on conceiving children during the treatment program and must agree to use a medically accepted form of contraception.\n4. Women of childbearing potential must have a negative serum pregnancy test within 2 weeks of beginning treatment.\n5. Patients must have relapsed lymphoma.\n6. ECOG performance status of 2 or better.\n\nExclusion Criteria:\n\n1. Pregnant or breast-feeding at the time of proposed study entry\n2. Clinical AIDS or ARS or known positive HIV serology\n3. History of malignant neoplasm, other than lymphoma, treated within two years prior to study entry (other than non-melanoma skin cancer or in situ cervical cancer) or where there is current evidence of recurrent or metastatic disease\n4. Psychiatric or additive disorders that would preclude obtaining informed consent\n5. Serum bilirubin \\> 1.5 times the upper limit of the normal range for the laboratory (ULN). Higher levels are acceptable if these are attributed to active hemolysis\n6. Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase \\[AST\\]) or serum glutamic-pyruvic transaminase (SGPT) (alanine aminotransferase \\[ALT\\]) levels \\> 2 times ULN\n7. Serum creatinine levels \\> 1.5 times ULN\n8. Platelets \\< 75,000/mm3\n9. Absolute neutrophil count \\< 1500/mm3\n10. Active infection including viral hepatitis\n11. Known or suspected hypersensitivity to mannitol, azacitidine, or rituximab\n12. Grade 3 or 4 neuropathy\n13. Advanced hepatic tumors\n14. Uncompensated heart failure'}, 'identificationModule': {'nctId': 'NCT00901069', 'briefTitle': 'Azacitidine With Rituximab, Vincristine, and Cyclophosphamide in Refractory Lymphoma', 'nctIdAliases': ['NCT00589160'], 'organization': {'class': 'OTHER', 'fullName': 'University of Kentucky'}, 'officialTitle': 'Azacitidine With Rituximab, Vincristine, and Cyclophosphamide in Refractory Lymphoma: A Phase I Trial', 'orgStudyIdInfo': {'id': '07-NHL-06-UK/CC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Azacitidine', 'interventionNames': ['Drug: Azacitidine with rituximab, vincristine, and cyclophosphamide']}], 'interventions': [{'name': 'Azacitidine with rituximab, vincristine, and cyclophosphamide', 'type': 'DRUG', 'description': 'Azacitidine cycle days 1-5 Cyclophosphamide cycle days 6-9 Vincristine cycle day 8 Rituximab cycle day 8 Rituximab is only for those patients with CD20+ lymphoma. Azacitidine 25 mg/m2\\^ Azacitidine 50 mg/m2\\^ Azacitidine 75 mg/m2\\^ Azacitidine 100 mg/m2\\^', 'armGroupLabels': ['Azacitidine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40536', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Kentucky', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}], 'overallOfficials': [{'name': 'Shams Shakil, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lucille P. Markey Cancer Center at University of Kentucky'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shams Shakil', 'class': 'OTHER'}, 'collaborators': [{'name': 'Celgene', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Shams Shakil', 'investigatorAffiliation': 'University of Kentucky'}}}}