Ignite Creation Date:
2025-12-24 @ 6:54 PM
Ignite Modification Date:
2025-12-25 @ 10:20 PM
Study NCT ID:
NCT00003757
Status:
COMPLETED
Last Update Posted:
2012-05-15
First Post:
1999-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rituximab in Treating Patients With Refractory or Recurrent Hairy Cell Leukemia Following Cladribine Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D007943', 'term': 'Leukemia, Hairy Cell'}], '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': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069283', 'term': 'Rituximab'}], 'ancestors': [{'id': 'D058846', 'term': 'Antibodies, Monoclonal, Murine-Derived'}, {'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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-14', 'studyFirstSubmitDate': '1999-11-01', 'studyFirstSubmitQcDate': '2003-04-29', 'lastUpdatePostDateStruct': {'date': '2012-05-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-04-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2002-07', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['progressive hairy cell leukemia, initial treatment', 'refractory hairy cell leukemia'], 'conditions': ['Leukemia']}, 'referencesModule': {'references': [{'pmid': '18603561', 'type': 'RESULT', 'citation': 'Zenhausern R, Simcock M, Gratwohl A, Hess U, Bargetzi M, Tobler A; Swiss Group for Clinical Cancer Research (SAKK). Rituximab in patients with hairy cell leukemia relapsing after treatment with 2-chlorodeoxyadenosine (SAKK 31/98). Haematologica. 2008 Sep;93(9):1426-8. doi: 10.3324/haematol.11564. Epub 2008 Jul 4. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.\n\nPURPOSE: Phase II trial to study the effectiveness of monoclonal antibody therapy consisting of rituximab in treating patients with refractory or recurrent hairy cell leukemia following cladribine therapy.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the rate of complete and partial remission, remission duration, and relapse free survival after treatment with rituximab in patients with refractory or recurrent hairy cell leukemia who previously received cladribine.\n* Determine the acute and long term toxicity of rituximab in these patients.\n\nOUTLINE: This is an open-label, multicenter study.\n\nPatients receive rituximab IV over several hours once a week for 4 weeks.\n\nPatients are followed every 3 months for 3 years and every 6 months thereafter.\n\nPROJECTED ACCRUAL: A total of 8-25 patients will be accrued for this study within 3 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically proven hairy cell leukemia (HCL)\n\n * Classic HCL\n\n * Hairy cells in the bone marrow and/or peripheral blood which co-express CD20/CD25 or CD20/CD11c, and/or which are positive for tartrate resistant acid phophatase (TRAP)\n * Prolymphocytic HCL variant\n\n * Lymphoid cells in the bone marrow and/or peripheral blood with morphology intermediate between typical hairy cells and prolymphocytes, which co-express CD20/CD11c but lack CD25 expression, and which are negative for TRAP\n* Progressive or recurrent disease after prior treatment with cladribine\n\n * Greater than 1 month since standard dose cladribine OR\n * Greater than 3 months since low dose cladribine\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 and over\n\nPerformance status:\n\n* WHO 0-2\n\nLife expectancy:\n\n* At least 3 months\n\nHematopoietic:\n\n* Not specified\n\nHepatic:\n\n* Bilirubin no greater than 2.0 mg/dL\n\nRenal:\n\n* Creatinine no greater than 2.3 mg/dL\n\nCardiovascular:\n\n* No serious cardiac disease\n\nOther:\n\n* No acute or chronic infection\n* HIV negative\n* No psychosis\n* Not pregnant or nursing\n* No other prior or concurrent malignancy except carcinoma in situ of the cervix or basal cell or squamous cell skin cancer\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* Not specified\n\nChemotherapy:\n\n* See Disease Characteristics\n* Recovered from prior chemotherapy\n\nEndocrine therapy:\n\n* Not specified\n\nRadiotherapy:\n\n* Not specified\n\nSurgery:\n\n* Not specified\n\nOther:\n\n* Recovered from prior therapy\n* No concurrent cytoreductive therapy'}, 'identificationModule': {'nctId': 'NCT00003757', 'briefTitle': 'Rituximab in Treating Patients With Refractory or Recurrent Hairy Cell Leukemia Following Cladribine Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Swiss Cancer Institute'}, 'officialTitle': 'Rituximab (IDEC-C2B8, Mabthera) in Patients With Hairy Cell Leukemia Relapsing After Treatment With 2-Chlorodeoxyadenosine (CDA)', 'orgStudyIdInfo': {'id': 'SAKK 31/98'}, 'secondaryIdInfos': [{'id': 'SWS-SAKK-31/98'}, {'id': 'EU-98073'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'rituximab', 'type': 'BIOLOGICAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CH-8008', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Klinik Hirslanden', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Albert von Rohr, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Klinik Hirslanden, Zurich'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Swiss Cancer Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}