Ignite Creation Date:
2025-12-24 @ 12:47 PM
Ignite Modification Date:
2025-12-27 @ 9:24 PM
Study NCT ID:
NCT00558961
Status:
TERMINATED
Last Update Posted:
2023-03-27
First Post:
2007-11-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dose Escalation Study of Gleevec and Chlorambucil in Previously Treated Chronic Lymphocytic Leukemia Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015451', 'term': 'Leukemia, Lymphocytic, Chronic, B-Cell'}, {'id': 'D007938', 'term': 'Leukemia'}], 'ancestors': [{'id': 'D015448', 'term': 'Leukemia, B-Cell'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'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': 'D000068877', 'term': 'Imatinib Mesylate'}, {'id': 'D002699', 'term': 'Chlorambucil'}], 'ancestors': [{'id': 'D001549', 'term': 'Benzamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'whyStopped': 'Unsatisfactory enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2005-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-23', 'studyFirstSubmitDate': '2007-11-15', 'studyFirstSubmitQcDate': '2007-11-15', 'lastUpdatePostDateStruct': {'date': '2023-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-11-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measure number of patients at maximum tolerated dose of Gleevec in combination with chlorambucil', 'timeFrame': '1 month'}], 'secondaryOutcomes': [{'measure': 'Report adverse events as a measure of safety', 'timeFrame': '6 months'}, {'measure': 'Report response to treatment as a measure of efficacy', 'timeFrame': '6 months'}, {'measure': 'Report level of gleevec concentration at different doses as a measure of pharmacokinetics', 'timeFrame': '1 month'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['CLL', 'chronic lymphocytic leukemia', 'leukemia', 'gleevec', 'chlorambucil'], 'conditions': ['Chronic Lymphocytic Leukemia']}, 'referencesModule': {'references': [{'pmid': '14712290', 'type': 'BACKGROUND', 'citation': 'Aloyz R, Grzywacz K, Xu ZY, Loignon M, Alaoui-Jamali MA, Panasci L. Imatinib sensitizes CLL lymphocytes to chlorambucil. Leukemia. 2004 Mar;18(3):409-14. doi: 10.1038/sj.leu.2403247.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine maximum tolerated dose of Gleevec in combination with Chlorambucil in previously treated CLL patients.', 'detailedDescription': 'A recent study by Aloyz et al demonstrated a synergistic effect of imatinib on chlorambucil-mediated cytotoxicity in CLL cells in vitro. Imatinib inhibits c-abl and sensitizes cells to chlorambucil. The Phase I component of the study will determine the maximum tolerated dose and recommended Phase II dose of Gleevec when used in combination with chlorambucil. Once the maximum tolerated dose has been determined, a total of 16 patients will be enrolled in the Phase II component of the study. This study will determine the dose limiting toxicities, pharmacokinetics and pharmacodynamics of Gleevec in combination with chlorambucil.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* B-cell chronic lymphocytic leukemia (a) Rai stage 0-II with indication for treatment by NCI Working Group Criteria: or (b) Rai stage III or IV.\n* Received a minimum of one prior chemotherapy regimen. Prior treatment with corticosteroids, immunotherapies, monoclonal antibodies or radiation therapy is permitted.\n* White blood cell count \\> 25 x 10\\^9/L\n* ECOG 0, 1,or 2.\n* Adequate renal and hepatic function\n* Platelets \\> 75 x 10\\^9/L, transfusion independent.\n* Neutrophils \\> 1.0 x 10\\^9/L, transfusion independent\n\nExclusion Criteria:\n\n* Documented prolymphocytic leukemia (PLL; prolymphocytes, 55% in blood)\n* Active cardiovascular disease as defined by NYHA class III-IV categorization.\n* Intercurrent illness or medical condition precluding safe administration of ribavirin.\n* Concurrent use of chronic steroids, except as replacement therapy for adrenal insufficiency\n* Known infection with HIV, Hepatitis B or C.\n* Concurrent malignancy (other than resected basal or squamous cell skin cancers or in-situ carcinoma).\n* Received any previous therapy for CLL within 28 days prior to study entry.'}, 'identificationModule': {'nctId': 'NCT00558961', 'acronym': 'GL-CLB-001', 'briefTitle': 'Dose Escalation Study of Gleevec and Chlorambucil in Previously Treated Chronic Lymphocytic Leukemia Patients', 'organization': {'class': 'OTHER', 'fullName': 'Jewish General Hospital'}, 'officialTitle': 'A Phase I-II Trial of Gleevec (Imatinib Mesylate) in Combination With Chlorambucil in Previously Treated Chronic Lymphocytic Leukemia (CLL) Patients', 'orgStudyIdInfo': {'id': 'CR0506PI'}, 'secondaryIdInfos': [{'id': 'REC:05-054'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'I', 'description': 'Gleevec Chlorambucil', 'interventionNames': ['Drug: Gleevec and Chlorambucil']}], 'interventions': [{'name': 'Gleevec and Chlorambucil', 'type': 'DRUG', 'otherNames': ['Gleevec (imatinib mesylate)', 'Chlorambucil'], 'description': 'The first cohort will receive Gleevec at 300 mg daily on days 1-10 and chlorambucil 8mg/m2/d from day 3-7. This will be repeated every 28 days. Cohort 2 will receive 400 mg Gleevec and Cohort 3 will receive 600 mg Gleevec. Each dose level may be expanded up to 6 patients if 1 of 3 patients experiences any dose limiting toxicities.', 'armGroupLabels': ['I']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'J4V 2H1', 'city': 'Greenfield Park', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Charles Lemoyne Hospital', 'geoPoint': {'lat': 45.48649, 'lon': -73.46223}}, {'zip': 'H4T 1E2', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Jewish General Hospital', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Sarit Assouline, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jewish General Hospital'}, {'name': 'Lawrence Panasci, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Jewish General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jewish General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Department of Oncology, McGill University', 'investigatorFullName': 'Sarit Assouline', 'investigatorAffiliation': 'Jewish General Hospital'}}}}