Ignite Creation Date:
2025-12-24 @ 5:19 PM
Ignite Modification Date:
2026-02-21 @ 8:40 AM
Study NCT ID:
NCT00419250
Status:
COMPLETED
Last Update Posted:
2019-11-08
First Post:
2007-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Dose Escalation Study of Lenalidomide in Relapsed or Refractory B-cell Chronic Lymphocytic Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015451', 'term': 'Leukemia, Lymphocytic, Chronic, B-Cell'}, {'id': 'D012008', 'term': 'Recurrence'}, {'id': 'D015448', 'term': 'Leukemia, B-Cell'}], 'ancestors': [{'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': 'D000077269', 'term': 'Lenalidomide'}], 'ancestors': [{'id': 'D010797', 'term': 'Phthalimides'}, {'id': 'D010795', 'term': 'Phthalic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010881', 'term': 'Piperidones'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D054833', 'term': 'Isoindoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2010-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-06', 'studyFirstSubmitDate': '2007-01-05', 'studyFirstSubmitQcDate': '2007-01-05', 'lastUpdatePostDateStruct': {'date': '2019-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-01-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety', 'timeFrame': 'February 2010'}], 'secondaryOutcomes': [{'measure': 'Response', 'timeFrame': 'February 2010'}, {'measure': 'Duration of response', 'timeFrame': 'February 2010'}, {'measure': 'Time to response', 'timeFrame': 'February 2010'}, {'measure': 'Progression free survival', 'timeFrame': 'February 2010'}, {'measure': 'Overall survival', 'timeFrame': 'February 2010'}, {'measure': 'Absolute lymphocyte count', 'timeFrame': 'February 2010'}, {'measure': 'Evaluation of minimal residual disease (MRD) by flow cytometry', 'timeFrame': 'February 2010'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['relapsed', 'refractory', 'fludarabine', 'Revlimid', 'lenalidomide', 'CLL', 'B-cell CLL', 'CC-5013', 'Chronic Lymphocytic Leukemia'], 'conditions': ['Chronic Lymphocytic Leukemia', 'Leukemia, B-Cell, Chronic']}, 'referencesModule': {'references': [{'pmid': '21879809', 'type': 'BACKGROUND', 'citation': 'Wendtner CM, Hillmen P, Mahadevan D, Buhler A, Uharek L, Coutre S, Frankfurt O, Bloor A, Bosch F, Furman RR, Kimby E, Gribben JG, Gobbi M, Dreisbach L, Hurd DD, Sekeres MA, Ferrajoli A, Shah S, Zhang J, Moutouh-de Parseval L, Hallek M, Heerema NA, Stilgenbauer S, Chanan-Khan AA. Final results of a multicenter phase 1 study of lenalidomide in patients with relapsed or refractory chronic lymphocytic leukemia. Leuk Lymphoma. 2012 Mar;53(3):417-23. doi: 10.3109/10428194.2011.618232. Epub 2011 Nov 15.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety of lenalidomide and to define the maximum tolerated escalation dose level (MTEDL) when administered by a stepwise dose-escalation schedule in subjects with relapsed or refractory B-cell CLL.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Documented diagnosis of B-cell CLL that has relapsed after or is refractory to at least one prior regimen. The prior regimen(s) must have included an alkylating agent and fludarabine (used in combination or separately)\n* ECOG \\< or = 2\n* Willing to agree to follow the pregnancy precautions.\n\nExclusion Criteria:\n\n* Pregnant or nursing women\n* Systemic treatment for B-cell CLL within 28 days of study start\n* Central nervous system involvement\n* History of renal failure requiring dialysis\n* Prior treatment with lenalidomide\n* Alemtuzumab therapy within 56 days of initiating lenalidomide treatment\n* ANC \\< 1000 / ul\n* Platelet count \\< 50,000 / ul\n* Calculated creatinine clearance \\< 60 mL/min (Cockroft-Gault method)\n* AST or ALT \\> 3.0 x upper limit of normal\n* Serum total bilirubin \\> 2.0 mg/dl\n* Neuropathy \\> or = Grade 2\n* Uncontrolled autoimmune hemolytic anemia or thrombocytopenia\n* Richter's transformation (active)"}, 'identificationModule': {'nctId': 'NCT00419250', 'briefTitle': 'A Dose Escalation Study of Lenalidomide in Relapsed or Refractory B-cell Chronic Lymphocytic Leukemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Celgene'}, 'officialTitle': 'A Phase 1, Multi-center, Open-label Study of the Safety and Efficacy of a Stepwise Dose-escalation Schedule of Lenalidomide Monotherapy in Subjects With Relapsed or Refractory B-cell Chronic Lymphocytic Leukemia', 'orgStudyIdInfo': {'id': 'CC-5013-CLL-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'dose-escalation to 5 mg lenalidomide (len)', 'description': 'escalate up to 5 mg once daily / 28-day cycle', 'interventionNames': ['Drug: lenalidomide']}, {'type': 'EXPERIMENTAL', 'label': 'dose-escalation to 10 mg lenalidomide (len)', 'description': 'escalate up to 10 mg once daily / 28-day cycle', 'interventionNames': ['Drug: lenalidomide']}, {'type': 'EXPERIMENTAL', 'label': 'dose-escalation to 15 mg lenalidomide (len)', 'description': 'escalate up to 15 mg once daily / 28-day cycle', 'interventionNames': ['Drug: lenalidomide']}, {'type': 'EXPERIMENTAL', 'label': 'dose-escalation to 20 mg lenalidomide (len)', 'description': 'escalate up to 20 mg once daily / 28-day cycle', 'interventionNames': ['Drug: lenalidomide']}, {'type': 'EXPERIMENTAL', 'label': 'dose-escalation to 25 mg lenalidomide (len)', 'description': 'escalate up to 25 mg once daily / 28-day cycle', 'interventionNames': ['Drug: lenalidomide']}], 'interventions': [{'name': 'lenalidomide', 'type': 'DRUG', 'otherNames': ['Revlimid, CC-5013'], 'armGroupLabels': ['dose-escalation to 5 mg lenalidomide (len)']}, {'name': 'lenalidomide', 'type': 'DRUG', 'otherNames': ['Revlimid, CC-5013'], 'armGroupLabels': ['dose-escalation to 10 mg lenalidomide (len)']}, {'name': 'lenalidomide', 'type': 'DRUG', 'otherNames': ['Revlimid, CC-5013'], 'armGroupLabels': ['dose-escalation to 15 mg lenalidomide (len)']}, {'name': 'lenalidomide', 'type': 'DRUG', 'otherNames': ['Revlimid, CC-5013'], 'armGroupLabels': ['dose-escalation to 20 mg lenalidomide (len)']}, {'name': 'lenalidomide', 'type': 'DRUG', 'otherNames': ['Revlimid, CC-5013'], 'armGroupLabels': ['dose-escalation to 25 mg lenalidomide (len)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Cancer Center', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '94704', 'city': 'Berkeley', 'state': 'California', 'country': 'United States', 'facility': 'Alta Bates Summit Comprehensive Cancer Center', 'geoPoint': {'lat': 37.87159, 'lon': -122.27275}}, {'zip': '92270', 'city': 'Rancho Mirage', 'state': 'California', 'country': 'United States', 'facility': 'Desert Hematology Oncology Medical Group, Inc.', 'geoPoint': {'lat': 33.73974, 'lon': -116.41279}}, {'zip': '32207', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Baptist Cancer Institute', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '34461', 'city': 'Lecanto', 'state': 'Florida', 'country': 'United States', 'facility': 'Cancer & Blood Disease Center', 'geoPoint': {'lat': 28.85165, 'lon': -82.4876}}, {'zip': '30060', 'city': 'Marietta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Northwest Georgia Oncology Centers, PC., Wellstar Health System', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}, {'zip': '83712', 'city': 'Boise', 'state': 'Idaho', 'country': 'United States', 'facility': 'Mountain States Tumor Institute', 'geoPoint': {'lat': 43.6135, 'lon': -116.20345}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Robert H. 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