Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-25 @ 9:38 PM
Study NCT ID:
NCT00021151
Status:
COMPLETED
Last Update Posted:
2014-01-09
First Post:
2001-07-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Compassionate Use of Campath-1H in Treating Patients With Refractory Prolymphocytic Leukemia or Chronic Lymphocytic Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D015451', 'term': 'Leukemia, Lymphocytic, Chronic, B-Cell'}, {'id': 'D015463', 'term': 'Leukemia, Prolymphocytic'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D015448', 'term': 'Leukemia, B-Cell'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'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': 'D000074323', 'term': 'Alemtuzumab'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2002-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-07', 'studyFirstSubmitDate': '2001-07-11', 'studyFirstSubmitQcDate': '2004-04-12', 'lastUpdatePostDateStruct': {'date': '2014-01-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-04-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2001-04', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['refractory chronic lymphocytic leukemia', 'prolymphocytic leukemia'], 'conditions': ['Leukemia']}, 'referencesModule': {'references': [{'pmid': '11986207', 'type': 'RESULT', 'citation': 'Keating MJ, Flinn I, Jain V, Binet JL, Hillmen P, Byrd J, Albitar M, Brettman L, Santabarbara P, Wacker B, Rai KR. Therapeutic role of alemtuzumab (Campath-1H) in patients who have failed fludarabine: results of a large international study. Blood. 2002 May 15;99(10):3554-61. doi: 10.1182/blood.v99.10.3554.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Compassionate use refers to providing a drug to a patient on humanitarian grounds before the drug has received official approval.\n\nPURPOSE: Compassionate use of Campath-1H in treating patients who have refractory prolymphocytic leukemia or chronic lymphocytic leukemia.', 'detailedDescription': 'OBJECTIVES: I. Expand access to Campath-1H for patients with refractory prolymphocytic leukemia or chronic lymphocytic leukemia.\n\nOUTLINE: Patients receive Campath-1H IV over 2 hours on days 1, 3, and 5. Treatment repeats weekly for 4-12 weeks in the absence of disease progression or unacceptable toxicity.\n\nPROJECTED ACCRUAL: Not specified'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS: Confirmed prolymphocytic leukemia (PLL) or chronic lymphocytic leukemia (CLL) PLL that has failed at least 1 prior regimen CLL that has failed prior fludarabine, defined as: No response Disease progression while receiving therapy OR Relapse within 6 months of completion of last dose\n\nPATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) (unless secondary to direct liver infiltration with CLL) Renal: Creatinine no greater than 2 times ULN Other: HIV negative No active infection No other severe concurrent disease No mental disorders No prior allergic reaction to rat or mouse-derived CDR-grafted humanized monoclonal antibodies Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception\n\nPRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy No concurrent cytotoxic therapy Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since prior radiotherapy Surgery: Not specified'}, 'identificationModule': {'nctId': 'NCT00021151', 'briefTitle': 'Compassionate Use of Campath-1H in Treating Patients With Refractory Prolymphocytic Leukemia or Chronic Lymphocytic Leukemia', 'organization': {'class': 'OTHER', 'fullName': 'Case Comprehensive Cancer Center'}, 'officialTitle': 'CAMPATH-1H Compassionate Treatment In Patients With PLL Who Have Failed At Least One Prior Regimen And CLL Patients Who Have Failed Fludarabine Therapy', 'orgStudyIdInfo': {'id': 'ILEX1999'}, 'secondaryIdInfos': [{'id': 'CWRU-ILEX-1999'}, {'id': 'ILEX-CAM511-A1'}, {'id': 'NCI-G01-1977'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Alemtuzumab', 'interventionNames': ['Biological: alemtuzumab']}], 'interventions': [{'name': 'alemtuzumab', 'type': 'BIOLOGICAL', 'armGroupLabels': ['Alemtuzumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44106-5065', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ireland Cancer Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Bernard J. Silver, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospitals Seidman Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Case Comprehensive Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, {'name': 'Genzyme, a Sanofi Company', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}