Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2025-12-29 @ 8:26 AM
Study NCT ID:
NCT00754650
Status:
COMPLETED
Last Update Posted:
2014-06-26
First Post:
2008-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Proof of Concept Study of the Safety, Tolerability, and Efficacy of Avastin (Bevacizumab) in Patients With Chemo-naive Chronic Lymphocytic Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015451', 'term': 'Leukemia, Lymphocytic, Chronic, B-Cell'}], 'ancestors': [{'id': 'D015448', 'term': 'Leukemia, B-Cell'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068258', 'term': 'Bevacizumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800 821-8590', 'title': 'Medical Communications', 'organization': 'Hoffmann-La Roche'}, 'certainAgreement': {'otherDetails': "The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'Intent-to-treat population: All participants who received at least 1 administration of the study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Bevacizumab 15 mg/kg', 'description': 'Participants received bevacizumab 15 mg/kg intravenously on Day 1 of each 3-week cycle for 8 cycles.', 'otherNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Bone Marrow Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bevacizumab 15 mg/kg', 'description': 'Participants received bevacizumab 15 mg/kg intravenously on Day 1 of each 3-week cycle for 8 cycles.'}], 'classes': [{'title': 'Interim staging', 'categories': [{'measurements': [{'value': '-20.0', 'groupId': 'OG000', 'lowerLimit': '-40.0', 'upperLimit': '0.0'}]}]}, {'title': 'End of treatment', 'categories': [{'measurements': [{'value': '-20.0', 'groupId': 'OG000', 'lowerLimit': '-40.0', 'upperLimit': '0.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to the end of treatment (up to 24 weeks)', 'description': 'Bone marrow response was defined as the change in percentage of infiltration at the interim staging (after 4 cycles of treatment) and the end of treatment.', 'unitOfMeasure': 'Percentage of infiltration', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population: All participants who received at least 1 administration of the study drug.'}, {'type': 'SECONDARY', 'title': 'Best Overall Response (BOR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bevacizumab 15 mg/kg', 'description': 'Participants received bevacizumab 15 mg/kg intravenously on Day 1 of each 3-week cycle for 8 cycles.'}], 'classes': [{'title': 'Interim staging - Complete response', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Interim staging - Partial response', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Interim staging - Stable disease', 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}]}]}, {'title': 'Interim staging - Progressive disease', 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}]}]}, {'title': 'End of treatment - Complete response', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'End of treatment - Partial response', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'End of treatment - Stable disease', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'End of treatment - Progressive disease', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to the end of treatment (up to 24 weeks)', 'description': 'The percentage of participants in each BOR category (complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD)) is reported. CR was defined as the disappearance of all target (TL) and non-target lesions (non-TL). PR was defined as ≥ 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD, or the persistence of 1 or more non-TLs. For TLs, SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD since treatment started. For non-TLs, SD was defined as the persistence of 1 or more lesions. PD was defined as ≥ 20% increase in the sum of the longest diameter of TLs, taking as reference the smallest SLD recorded since treatment started, the unequivocal progression of existing non-TLs, or the appearance of 1 or more new lesions.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population: All participants who received at least 1 administration of the study drug.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Bevacizumab 15 mg/kg', 'description': 'Participants received bevacizumab 15 mg/kg intravenously on Day 1 of each 3-week cycle for 8 cycles.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Disease Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Bevacizumab 15 mg/kg', 'description': 'Participants received bevacizumab 15 mg/kg intravenously on Day 1 of each 3-week cycle for 8 cycles.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.0', 'spread': '9.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent-to-treat population: All participants who received at least 1 administration of the study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-27', 'studyFirstSubmitDate': '2008-09-17', 'resultsFirstSubmitDate': '2014-05-27', 'studyFirstSubmitQcDate': '2008-09-17', 'lastUpdatePostDateStruct': {'date': '2014-06-26', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-05-27', 'studyFirstPostDateStruct': {'date': '2008-09-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-06-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bone Marrow Response', 'timeFrame': 'Baseline to the end of treatment (up to 24 weeks)', 'description': 'Bone marrow response was defined as the change in percentage of infiltration at the interim staging (after 4 cycles of treatment) and the end of treatment.'}], 'secondaryOutcomes': [{'measure': 'Best Overall Response (BOR)', 'timeFrame': 'Baseline to the end of treatment (up to 24 weeks)', 'description': 'The percentage of participants in each BOR category (complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD)) is reported. CR was defined as the disappearance of all target (TL) and non-target lesions (non-TL). PR was defined as ≥ 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD, or the persistence of 1 or more non-TLs. For TLs, SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD since treatment started. For non-TLs, SD was defined as the persistence of 1 or more lesions. PD was defined as ≥ 20% increase in the sum of the longest diameter of TLs, taking as reference the smallest SLD recorded since treatment started, the unequivocal progression of existing non-TLs, or the appearance of 1 or more new lesions.'}]}, 'conditionsModule': {'conditions': ['Lymphocytic Leukemia, Chronic']}, 'descriptionModule': {'briefSummary': 'This single arm study evaluated the bone marrow response, safety, and tolerability of 6 months treatment with Avastin (bevacizumab) monotherapy in patients with chronic lymphocytic leukemia. Patients received 8 cycles (21 days duration) of Avastin monotherapy (15mg/kg) with 6 months of follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female patients, ≥ 18 years of age.\n* B-chronic lymphocytic leukemia not yet requiring treatment.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.\n* No previous treatment of chronic lymphocytic leukemia (CLL) by chemotherapy, radiotherapy, or immunotherapy.\n* Life expectancy \\> 6 months.\n\nExclusion Criteria:\n\n* Central nervous system (CNS) involvement by lymphoma or any evidence of spinal cord compression.\n* Computed tomography (CT) scan based evidence of tumor invading major blood vessels.\n* Gastrointestinal (GI) tract involvement by CLL.\n* Active viral, bacterial, or fungal infection.\n* Uncontrolled hypertension, cerebrovascular accident/stroke (≤ 6 months prior to randomization), myocardial infarction (≤ 6 months prior to randomization), unstable angina (≥ New York Heart Association (NYHA) Grade IV), thrombosis within 6 months before enrollment, NYHA Grade II congestive heart failure, or serious cardiac arrhythmia requiring ongoing medication.'}, 'identificationModule': {'nctId': 'NCT00754650', 'briefTitle': 'A Proof of Concept Study of the Safety, Tolerability, and Efficacy of Avastin (Bevacizumab) in Patients With Chemo-naive Chronic Lymphocytic Leukemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'ML21206 - Bevacizumab in Chronic Lymphocytic Leukemia: A Proof of Concept Study', 'orgStudyIdInfo': {'id': 'ML21206'}, 'secondaryIdInfos': [{'id': '2007-004824-19', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bevacizumab 15 mg/kg', 'description': 'Participants received bevacizumab 15 mg/kg intravenously on Day 1 of each 3-week cycle for 8 cycles.', 'interventionNames': ['Drug: Bevacizumab']}], 'interventions': [{'name': 'Bevacizumab', 'type': 'DRUG', 'otherNames': ['Avastin'], 'description': 'Bevacizumab was supplied as a sterile liquid in single-use vials.', 'armGroupLabels': ['Bevacizumab 15 mg/kg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5020', 'city': 'Salzburg', 'country': 'Austria', 'geoPoint': {'lat': 47.79941, 'lon': 13.04399}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}