Ignite Creation Date:
2025-12-24 @ 3:43 PM
Ignite Modification Date:
2026-03-13 @ 10:19 AM
Study NCT ID:
NCT00066092
Status:
COMPLETED
Last Update Posted:
2008-02-28
First Post:
2003-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pegfilgrastim PBPC Mobilization Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D006689', 'term': 'Hodgkin Disease'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C455861', 'term': 'pegfilgrastim'}, {'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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-02', 'completionDateStruct': {'date': '2004-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-02-20', 'studyFirstSubmitDate': '2003-08-04', 'studyFirstSubmitQcDate': '2003-08-04', 'lastUpdatePostDateStruct': {'date': '2008-02-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-08-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CD34+ collection during the collection phase', 'timeFrame': '10 days'}], 'secondaryOutcomes': [{'measure': 'Time to ANC and platelet engraftment post-transplant', 'timeFrame': '100 days'}]}, 'conditionsModule': {'keywords': ['PBPC transplant', "Hodgkin's Disease", "Non-Hodgkin's Lymphoma", 'NHL', 'mobilization'], 'conditions': ['Lymphoma', "Hodgkin's Lymphoma", "Non-Hodgkin's Lymphoma", 'Hematology', 'Oncology']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}, {'url': 'http://download.veritasmedicine.com/REGFILES/amgen/Amgen_results_disclaimer.pdf', 'label': 'Notice regarding posted summaries of trial results'}, {'url': 'http://download.veritasmedicine.com/REGFILES/amgen/20020112.pdf', 'label': 'To access clinical trial results information click on this link'}]}, 'descriptionModule': {'briefSummary': "This is a randomized, double-blind, multi-center study to assess the safety and effectiveness of using a single subcutaneous (under the skin) injection of pegfilgrastim or daily subcutaneous injections of Filgrastim to mobilize stem cells for autologous transplantation in patients with Hodgkin's or non-Hodgkin's lymphoma.", 'detailedDescription': "This is a research study for Hodgkin's Disease and Non-Hodgkin's Lymphoma (NHL) patients who will receive high-dose chemotherapy with autologous peripheral blood stem cell (PBSC or PBPC) transplant. The chemotherapy doses are high enough to severely suppress the bone marrow (where blood cells are made) and cause very low blood counts. A collection of stem cells (very young blood cells) followed by reinfusion to restore blood counts will be done to stimulate recovery of your blood counts. This procedure is called leukapheresis. Giving growth factors to patients is a method to increase the number of PBPC that can be collected during leukapheresis. This process of giving growth factors to patients is called mobilization (moving cells from the bone marrow to the peripheral blood where they can be collected). The purpose of this study is to determine if pegfilgrastim, an investigational drug, can safely and effectively mobilize stem cells. Filgrastim (also known as NEUPOGEN® or G-CSF) is approved by the FDA for stem cell mobilization. Pegfilgrastim is a modified version of Filgrastim that is longer acting."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "* Hodgkin's or non-Hodgkin's lymphoma patients suitable for an autologous PBPC transplant - No previous bone marrow or PBPC transplant"}, 'identificationModule': {'nctId': 'NCT00066092', 'briefTitle': 'Pegfilgrastim PBPC Mobilization Study', 'nctIdAliases': ['NCT00060229'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': "Randomized, Double-Blind Study of Peripheral Blood Progenitor Cell (PBPC) Mobilization by Pegfilgrastim or Filgrastim for Autologous Transplantation in Subjects With Hodgkin's or Non-Hodgkin's Lymphoma.", 'orgStudyIdInfo': {'id': '20020112'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pegfilgrastim 6 mg', 'description': 'Pegfilgrastim 6 mg given once for PBPC mobilization', 'interventionNames': ['Drug: pegfilgrastim 6 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Pegfilgrastim 12 mg', 'description': 'Pegfilgrastim 12 mg given once for PBPC mobilization', 'interventionNames': ['Drug: pegfilgrastim 12 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'filgrastim', 'description': 'Filgrastim given daily for PBPC mobilization', 'interventionNames': ['Drug: filgrastim']}], 'interventions': [{'name': 'pegfilgrastim 12 mg', 'type': 'DRUG', 'description': 'Pegfilgrastim 12 mg given once for PBPC mobilization', 'armGroupLabels': ['Pegfilgrastim 12 mg']}, {'name': 'filgrastim', 'type': 'DRUG', 'description': 'Filgrastim given daily for PBPC mobilization', 'armGroupLabels': ['filgrastim']}, {'name': 'pegfilgrastim 6 mg', 'type': 'DRUG', 'description': 'Pegfilgrastim 6 mg given once for PBPC mobilization', 'armGroupLabels': ['Pegfilgrastim 6 mg']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Amgen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amgen', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Global Development Leader', 'oldOrganization': 'Amgen Inc.'}}}}