Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2025-12-25 @ 8:59 PM
Study NCT ID:
NCT00771056
Status:
TERMINATED
Last Update Posted:
2016-08-22
First Post:
2008-10-08
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Hydroxychloroquine in Untreated B-CLL Patients
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': 'D006886', 'term': 'Hydroxychloroquine'}], 'ancestors': [{'id': 'D002738', 'term': 'Chloroquine'}, {'id': 'D000634', 'term': 'Aminoquinolines'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'krai@nshs.edu', 'phone': '(718)470-4050', 'title': 'Kanti R Rai, MD', 'organization': 'Northwell Health (formerly North Shore LIJ Health System)'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse event reporting wil be reported if applicable as subjects are monitored on a monthly basis.', 'description': 'Subjects were monitored monthly by physician for adverse events from hydroxychloroquine.', 'eventGroups': [{'id': 'EG000', 'title': 'Hydroxychloroquine', 'description': 'Hydroxychloroquine 400 mg po daily for up to one year.\n\nHydroxychloroquine: 400mg by mouth daily x 1 year', 'otherNumAtRisk': 23, 'otherNumAffected': 0, 'seriousNumAtRisk': 23, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Hydroxychloroquine', 'description': 'Hydroxychloroquine 400 mg po daily for up to one year.'}], 'classes': [{'categories': [{'measurements': [{'value': '54.4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 yr', 'description': 'Percentage of participants with a reduction of the absolute lymphocytic count- ALC', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Next Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Hydroxychloroquine', 'description': 'Hydroxychloroquine 400 mg po daily for up to one year.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.3', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '7'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 yr', 'description': 'number of months to time from last HCQ dose to next CLL treatment', 'unitOfMeasure': 'months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'only analyzed for participants that were treated within one year post last dose of hydroxychloroquine dose'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Hydroxychloroquine', 'description': 'Hydroxychloroquine 400 mg po daily for up to one year.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}]}], 'recruitmentDetails': 'Recruitment was from April 2009 through termination December 2011. Patients were identified and enrolled in the CLL Research and Treatment Program where they already were being seen for care of their CLL.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Hydroxychloroquine', 'description': 'Hydroxychloroquine 400 mg po daily for up to one year.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000', 'lowerLimit': '44', 'upperLimit': '77'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'whyStopped': 'study suspended while data is reviewed for safety and efficacy.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-18', 'studyFirstSubmitDate': '2008-10-08', 'resultsFirstSubmitDate': '2015-12-17', 'studyFirstSubmitQcDate': '2008-10-09', 'lastUpdatePostDateStruct': {'date': '2016-08-22', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-06-15', 'studyFirstPostDateStruct': {'date': '2008-10-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-07-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Response', 'timeFrame': '1 yr', 'description': 'Percentage of participants with a reduction of the absolute lymphocytic count- ALC'}], 'secondaryOutcomes': [{'measure': 'Time to Next Treatment', 'timeFrame': '1 yr', 'description': 'number of months to time from last HCQ dose to next CLL treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['untreated'], 'conditions': ['B-Cell Chronic Lymphocytic Leukemia']}, 'descriptionModule': {'briefSummary': 'Eligible CLL patients who sign an informed consent will be started on hydroxychloroquine 400mg po daily for up to one year. They will be monitored for disease status as well as adverse reactions after two weeks and then every 4 weeks. Ophthalmologic exams is required at baseline and every 6 months or sooner if the patient develops any visual disturbances.', 'detailedDescription': 'This is a single-center, open-label, single arm Phase 2 study evaluating the feasibility, and efficacy of treating CLL subjects with hydroxychloroquine. The study schema and schedule of events are as follows:\n\nPrior to beginning hydroxychloroquine:\n\n* Blood samples to be taken.\n* Baseline tests confirming diagnosis of CLL as defined above (if not already obtained in records)\n* Physical exam performed\n* Either six months prior or 4 weeks within starting HCQ ophthalmologic exam documented\n* Days 1-365 subject takes hydroxychloroquine 400mg/day\n* At 2 weeks: CBC and chemistry\n* Every 4 weeks: CBC, chemistry, history (including the inquiry about the presence or absence of visual symptoms) and physical exam.\n* Starting at 4 weeks: blood samples taken for laboratory companion studies taken at office visit every 8 weeks.\n* At 6 months (+ or - 30 days): subject will have follow up ophthalmologic exam). This will also be done in the presence of any visual/ocular symptoms.\n\nAll subjects must meet the selection criteria for registration in this study. All subjects must have a peripheral blood sample submitted. It is estimated that approximately 70 subjects will be screened. The anticipated accrual period is 12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Flow cytometry confirmed B-CLL\n* No prior chemotherapy or immunotherapy\n* Performance status 0-2\n* Age \\> 18 years old\n* If childbearing age, woman you must be willing to use birth control for length of hydroxychloroquine use\n* Must have capacity to consent for study and sign consent form\n* Asymptomatic CLL not requiring treatment at time of study entry\n\nExclusion Criteria:\n\n* Pregnancy\n* Significant optic nerve pathology as documented by an opthalmologic exam\n* Hypersensitivity to 4-aminoquinoline compound\n* Patients taking cardiac glycosides and cyclosporine'}, 'identificationModule': {'nctId': 'NCT00771056', 'briefTitle': 'Hydroxychloroquine in Untreated B-CLL Patients', 'organization': {'class': 'OTHER', 'fullName': 'Northwell Health'}, 'officialTitle': 'Phase II Study to Evaluate the Tolerability and Efficacy of Treatment of Previously Untreated B-Cell Chronic Lymphocytic Leukemia (B-CLL) Patients With Hydroxychloroquine.', 'orgStudyIdInfo': {'id': '08-088'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hydroxychloroquine', 'description': 'Hydroxychloroquine 400 mg po daily for up to one year.', 'interventionNames': ['Drug: Hydroxychloroquine']}], 'interventions': [{'name': 'Hydroxychloroquine', 'type': 'DRUG', 'otherNames': ['Plaquenil'], 'description': '400mg by mouth daily x 1 year', 'armGroupLabels': ['Hydroxychloroquine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11040', 'city': 'New Hyde Park', 'state': 'New York', 'country': 'United States', 'facility': 'Long Island Jewish Medical Center CLL Research and Treatment Center', 'geoPoint': {'lat': 40.7351, 'lon': -73.68791}}], 'overallOfficials': [{'name': 'Kanti R Rai, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NSLIJ'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan to contact each individual patient (participant in the trial) and inform hem/her of results of this trial as it affects each one of them.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwell Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Kanti Rai, MD', 'investigatorAffiliation': 'Northwell Health'}}}}