Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-25 @ 9:30 PM
Study NCT ID:
NCT05834751
Status:
UNKNOWN
Last Update Posted:
2023-04-28
First Post:
2023-04-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
the Efficacy and Safety of PEG-rhG-CSF in Mobilizing Autologous Hematopoietic Stem Cells in Lymphoma
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'}, {'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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 144}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-18', 'studyFirstSubmitDate': '2023-04-06', 'studyFirstSubmitQcDate': '2023-04-18', 'lastUpdatePostDateStruct': {'date': '2023-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mobilization success rate', 'timeFrame': '48 months', 'description': 'Accumulate CD34+cells ≥ 2×106/kg for 3 times or less'}], 'secondaryOutcomes': [{'measure': 'White blood cell trough and peak', 'timeFrame': '30 days', 'description': 'The treatment period is from the beginning of chemotherapy to the end of collection, the trough value is recorded at the beginning of chemotherapy, and the peak value is recorded after PEG-rhG-CSF is applied'}, {'measure': 'Speed of recovery', 'timeFrame': '30 days', 'description': 'The number of days when the leucocyte trough rose to the peak'}, {'measure': 'Time of highest point of CD34+ cells', 'timeFrame': '30 days', 'description': 'Time of highest point of CD34+ cells'}, {'measure': 'Single acquisition volume', 'timeFrame': '30 days', 'description': 'Single acquisition volume'}, {'measure': 'Acquisition times', 'timeFrame': '30 days', 'description': 'Acquisition times'}, {'measure': 'Administration times of rhG-CSF', 'timeFrame': '30 days', 'description': 'Administration times of rhG-CSF'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lymphoma']}, 'descriptionModule': {'briefSummary': 'A single center, non-inferiority, two-way cohort clinical study to evaluate the efficacy and safety of pegylated recombinant human granulocyte stimulating factor injection in the mobilization of autologous hematopoietic stem cells in lymphoma.', 'detailedDescription': 'The objective was to to evaluate the efficacy and safety of pegylated recombinant human granulocyte stimulating factor injection in the mobilization of autologous hematopoietic stem cells in lymphoma.\n\nlymphoma patients who need to be prepared for autologous hematopoietic stem cell transplantation; KPS score ≥70; Ccr≥ 50 mL/min, TBIL\\< 25.65 umol/L, ALT and AST \\< 2 times the upper limit of normal value;'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age 18-65 years old, regardless of gender;\n2. lymphoma patients who need to be prepared for autologous hematopoietic stem cell transplantation;\n3. KPS score ≥70;\n4. Ccr≥ 50 mL/min, TBIL\\< 25.65 umol/L, ALT and AST \\< 2 times the upper limit of normal value;\n5. ANC ≥ 1.5×109/L，PLT ≥ 80×109/L，Hb ≥ 75g/L，WBC ≥ 3.0×109/L；\n6. Patients can tolerate chemotherapy；\n7. No active infection before chemotherapy;\n8. The retrospective enrolled subjects are exempted from informed consent for data collection, and the prospective enrolled subjects voluntarily participate in this experiment and sign the informed consent form;\n9. The researcher thinks that the subjects can benefit.\n\nExclusion Criteria:\n\n1. Patients with megaspleen (when inhaling deeply, the spleen exceeds the right umbilicus and/or below the umbilical level);\n2. Those who have received mobilization and transplantation of allogeneic or autologous hematopoietic stem cells before;\n3. Subjects who have evidence of serious or uncontrollable systemic diseases (such as unstable or irreparable respiratory, heart, liver or kidney diseases) according to the researcher's judgment;\n4. severe mental or nervous system diseases;\n5. Those who are allergic to PEG-rhG-CSF, rhG-CSF and any active ingredients or auxiliary materials of other preparations expressed by Escherichia coli, or have a clear history of protein drug allergy, specific allergic reaction (asthma, rheumatism, eczema dermatitis) or have had other serious allergic reactions;\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': 'NCT05834751', 'briefTitle': 'the Efficacy and Safety of PEG-rhG-CSF in Mobilizing Autologous Hematopoietic Stem Cells in Lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'The First Hospital of Jilin University'}, 'officialTitle': 'Clinical Study on the Effectiveness and Safety of Pegylated Recombinant Human Granulocyte Stimulating Factor Injection and PEG-rhG-CSF in Mobilizing Autologous Hematopoietic Stem Cells in Lymphoma.', 'orgStudyIdInfo': {'id': 'CSPC-JYL-PBSCT-03A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'experimental group', 'description': 'PEG-rhG-CSF', 'interventionNames': ['Drug: PEG-rhG-CSF']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control group', 'description': 'rhG-CSF', 'interventionNames': ['Drug: RhG-CSF']}], 'interventions': [{'name': 'PEG-rhG-CSF', 'type': 'DRUG', 'otherNames': ['pegfilgrastim'], 'description': '48-72 hours after chemotherapy,9 mg of PEG-rhG-CSF was injected subcutaneously for mobilization', 'armGroupLabels': ['experimental group']}, {'name': 'RhG-CSF', 'type': 'DRUG', 'otherNames': ['filgrastim'], 'description': 'After clinical evaluation, rhG-CSF was given 10μ g/kg/d for mobilization until the stem cell collection was completed.', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '130021', 'city': 'Changchun', 'state': 'Jilin', 'country': 'China', 'contacts': [{'name': 'Ou Bai, doctor', 'role': 'CONTACT', 'email': 'oubai@163.com', 'phone': '13039046656'}], 'facility': 'The First Bethune Hospital of Jilin University', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}], 'centralContacts': [{'name': 'Ou Bai, doctor', 'role': 'CONTACT', 'email': 'oubai16@163.com', 'phone': '13039046656'}], 'overallOfficials': [{'name': 'Ou Bai, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Hospital of Jilin University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ou Bai, MD/PHD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Ou Bai, MD/PHD', 'investigatorAffiliation': 'The First Hospital of Jilin University'}}}}