Ignite Creation Date:
2025-12-24 @ 12:46 PM
Ignite Modification Date:
2025-12-30 @ 8:46 PM
Study NCT ID:
NCT00233961
Status:
COMPLETED
Last Update Posted:
2013-02-04
First Post:
2005-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
G-CSF in Stimulating Peripheral Stem Cells for Autologous Stem Cell Transplant in Treating Patients With Chronic Phase Chronic Myeloid Leukemia in Complete Remission
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D015466', 'term': 'Leukemia, Myeloid, Chronic-Phase'}], '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': 'D015464', 'term': 'Leukemia, Myelogenous, Chronic, BCR-ABL Positive'}, {'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D001855', 'term': 'Bone Marrow 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': 'D000069585', 'term': 'Filgrastim'}], 'ancestors': [{'id': 'D016179', 'term': 'Granulocyte Colony-Stimulating Factor'}, {'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-01', 'completionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-01', 'studyFirstSubmitDate': '2005-10-05', 'studyFirstSubmitQcDate': '2005-10-05', 'lastUpdatePostDateStruct': {'date': '2013-02-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-10-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility and safety of harvesting chronic myeloid leukemia (CML) patients in continuous complete remission (CCR) by adequate CD34+ stem cell numbers post-harvest'}], 'secondaryOutcomes': [{'measure': 'Effect of discontinuation of imatinib during harvesting by cytogenetic evaluation post-harvest'}]}, 'conditionsModule': {'keywords': ['chronic phase chronic myelogenous leukemia'], 'conditions': ['Leukemia']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Giving colony-stimulating factors, such as G-CSF, helps stem cells move from the bone marrow to the blood so they can be collected and stored until transplant.\n\nPURPOSE: This phase I trial is studying the side effects of G-CSF in stimulating peripheral stem cells for autologous stem cell transplant in treating patients with chronic phase chronic myeloid leukemia in remission.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the feasibility and safety of harvesting adequate numbers of CD34-positive peripheral blood stem cells using filgrastim (G-CSF) in patients with chronic phase chronic myeloid leukemia in complete cytogenetic remission.\n* Determine the safety of temporarily discontinuing treatment with imatinib mesylate and using G-CSF during the harvesting procedure, in terms of the percentage of Philadelphia chromosome (Ph)-positive cells before and after stem cell harvest, in these patients.\n\nOUTLINE: Patients receive filgrastim (G-CSF) and then undergo apheresis for up to 5 days.\n\nAfter completion of apheresis, patients resume treatment with imatinib mesylate off study. Patients may later undergo autologous peripheral blood stem cell transplantation, when deemed necessary.\n\nPROJECTED ACCRUAL: A total of 20 patients will be accrued for this study within 2 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Diagnosis of chronic phase chronic myeloid leukemia\n\n * In complete cytogenetic remission, confirmed by bone marrow biopsy within the past month\n* Has been receiving imatinib mesylate for ≥ 3 months\\* NOTE: \\*Imatinib mesylate is held during the study harvesting procedure\n* No myelofibrosis on bone marrow ≥ 3+\n* Ineligible for or refused allogeneic stem cell transplantation\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* Over 18\n\nPerformance status\n\n* ECOG 0-1\n\nLife expectancy\n\n* Not specified\n\nHematopoietic\n\n* WBC \\> 3,000/mm\\^3\n* Platelet count \\> 100,000/mm\\^3\n\nHepatic\n\n* Adequate hepatic function for stem cell transplantation\n\nRenal\n\n* Adequate renal function for stem cell transplantation\n\nCardiovascular\n\n* Adequate cardiovascular function for stem cell transplantation\n\nPulmonary\n\n* Adequate pulmonary function for stem cell transplantation\n\nOther\n\n* HIV negative\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* No other concurrent biologic therapy\n\nChemotherapy\n\n* More than 4 weeks since prior chemotherapy\n* No other concurrent chemotherapy\n\nEndocrine therapy\n\n* Not specified\n\nRadiotherapy\n\n* No concurrent radiotherapy\n\nSurgery\n\n* No concurrent surgery\n\nOther\n\n* No other concurrent experimental therapy'}, 'identificationModule': {'nctId': 'NCT00233961', 'briefTitle': 'G-CSF in Stimulating Peripheral Stem Cells for Autologous Stem Cell Transplant in Treating Patients With Chronic Phase Chronic Myeloid Leukemia in Complete Remission', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Peripheral Blood Stem Cell Mobilization With Filgrastim in Patients With Chronic Myeloid Leukemia in Cytogenetic Response', 'orgStudyIdInfo': {'id': 'CDR0000441128'}, 'secondaryIdInfos': [{'id': 'CPMC-AAAA9963'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'filgrastim', 'type': 'BIOLOGICAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Gwen L. Nichols, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Herbert Irving Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Herbert Irving Comprehensive Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}]}}}