Ignite Creation Date:
2025-12-24 @ 1:32 PM
Ignite Modification Date:
2025-12-28 @ 1:08 AM
Study NCT ID:
NCT06026995
Status:
UNKNOWN
Last Update Posted:
2023-09-07
First Post:
2023-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study on PEG-rhG-CSF in Mobilizing Autologous Hematopoietic Stem Cells
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'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': 'C423652', 'term': 'pegylated granulocyte colony-stimulating factor'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 174}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2024-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-31', 'studyFirstSubmitDate': '2023-08-31', 'studyFirstSubmitQcDate': '2023-08-31', 'lastUpdatePostDateStruct': {'date': '2023-09-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The proportion of patients with CD34+ cells ≥2×106/kg', 'timeFrame': '28 days', 'description': 'The proportion of patients with CD34+ cells ≥2×106/kg'}], 'secondaryOutcomes': [{'measure': 'CD34+cell count', 'timeFrame': '28 days', 'description': 'CD34+cell count'}, {'measure': 'Acquisition times', 'timeFrame': '28 days', 'description': 'The number of times a patient needs to collect a sufficient number of CD34+ cells'}, {'measure': 'Mobilization time', 'timeFrame': '28 days', 'description': 'Time interval from mobilization to collection'}, {'measure': 'Hematopoietic reconstruction time after transplantation', 'timeFrame': '3 months', 'description': 'Hematopoietic reconstruction time after transplantation'}, {'measure': 'complication', 'timeFrame': '3 months', 'description': 'complication'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lymphoma']}, 'descriptionModule': {'briefSummary': 'This study is a randomized controlled, open and multi-center clinical study. Patients who meet the selection criteria and do not meet the exclusion criteria are randomly given PEG-rhG-CSF with a fixed dose of 12mg when white blood cells reach the lowest point, or given rhG-CSF with a daily mobilization of 5-10μ g/kg until the collection is completed, so as to evaluate the effectiveness and safety of PEG-rhG-CSF in mobilizing autologous stem cells for lymphoma and multiple myeloma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 18-65 years old, regardless of sex;\n2. Patients with lymphoma and multiple myeloma who need autologous hematopoietic stem cell transplantation;\n3. KPS score ≥70;\n4. creatinine clearance rate ≥ 50mL/min, total bilirubin level \\< 1.5mg/dL, ALT and AST \\< 2 times the upper limit of normal value;\n5. Absolute neutrophil count (ANC)≥1.5×109/L, platelet count ≥80×109/L, Hb≥ 75g/L, WBC ≥ 3.0× 109/L;\n6. Patients can tolerate chemotherapy;\n7. No active infection before chemotherapy;\n8. The patient voluntarily participated in this trial and signed the informed consent form;\n9. The researcher thinks that the subjects can benefit.\n\nExclusion Criteria:\n\n1. Those who have previously received allogeneic or autologous hematopoietic stem cell transplantation;\n2. Serious or uncontrolled virus infection: HIV, syphilis positive;\n3. Severe dysfunction of internal organs;\n4. severe mental or nervous system diseases;\n5. allergic to PEG-rhG-CSF, rhG-CSF and other preparations or proteins expressed in Escherichia coli;\n6. pregnant or lactating female patients; Women of childbearing age refuse to accept contraceptive measures; Those who plan to become pregnant during the study period;\n7. The researcher judges other subjects who are not suitable to participate.'}, 'identificationModule': {'nctId': 'NCT06026995', 'briefTitle': 'Clinical Study on PEG-rhG-CSF in Mobilizing Autologous Hematopoietic Stem Cells', 'organization': {'class': 'OTHER', 'fullName': 'Chongqing University Cancer Hospital'}, 'officialTitle': 'Clinical Study on the Effectiveness and Safety of PEG-rhG-CSF in Mobilizing Autologous Hematopoietic Stem Cells for Lymphoma and Multiple Myeloma', 'orgStudyIdInfo': {'id': 'CSPC-JYL-PBSCT-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'experimental group', 'interventionNames': ['Drug: PEG-rhG-CSF']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control group', 'interventionNames': ['Drug: RhG-CSF']}], 'interventions': [{'name': 'PEG-rhG-CSF', 'type': 'DRUG', 'description': 'Subcutaneous injection with a fixed dose of 12 mg', 'armGroupLabels': ['experimental group']}, {'name': 'RhG-CSF', 'type': 'DRUG', 'description': 'Inject rhG-CSF 5-10 μg/kg subcutaneously every day', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400030', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yao Liu', 'role': 'CONTACT', 'email': '64823926@qq.com', 'phone': '13228684685'}], 'facility': 'Chongqing University Cancer Hospital', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'centralContacts': [{'name': 'Yao Liu, doctor', 'role': 'CONTACT', 'email': '64823926@qq.com', 'phone': '132 2868 4685'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chongqing University Cancer Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'CSPC Baike (Shandong) Biopharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Yao Liu', 'investigatorAffiliation': 'Chongqing University Cancer Hospital'}}}}