Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2026-02-28 @ 10:35 PM
Study NCT ID:
NCT04460508
Status:
UNKNOWN
Last Update Posted:
2022-07-07
First Post:
2020-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mecapegfilgrastim(PEG-G-CSF) for Prophylaxis of Chemotherapy-induced Neutropenia in Patients With 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 170}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-12-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2023-03-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-06', 'studyFirstSubmitDate': '2020-06-28', 'studyFirstSubmitQcDate': '2020-07-01', 'lastUpdatePostDateStruct': {'date': '2022-07-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of grade ≥3 neutropenia in cycle 1', 'timeFrame': '21 days', 'description': 'Duration of subjects developing ANC lower than 1.0 × 109/L'}], 'secondaryOutcomes': [{'measure': 'Incidence of grade ≥3 neutropenia in cycle 1-4', 'timeFrame': '84 days', 'description': 'Proportion of subjects developing ANC lower than 1.0 × 109/L from cycle 1 to cycle 4'}, {'measure': 'Incidenc of febrile neutropenia (FN) in cycle 1-4', 'timeFrame': '84 days', 'description': 'Febrile neutropenia means the ANC count is less than 1,000/mm3 and body temperature is more than 38.5 degrees celsius from cycle 1 to cycle 4'}, {'measure': 'Incidence of adverse events (AEs)', 'timeFrame': '84 days', 'description': 'Analysis of adverse events (AEs) are based on treatment-related AEs (trAEs) according to the Common Terminology Criteria for Adverse Events, version 5.0'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chemotherapy-induced Neutropenia', 'Lymphoma']}, 'descriptionModule': {'briefSummary': 'Neutropenia is one of the most frequent adverse effects of chemotherapy, and the main factor to limit the dosage and the continuation of chemotherapy.A newly pegylated rhG-CSF was independently developed by JIANGSU HENGRUI Medicine Co., Ltd, China. Phase 1a, 1b and phase 2 trials have shown that pegylated rhG-CSF has decreased renal clearance, increased plasma half-life, and prolonged efficacy in compare with filgrastim.\n\nThis study is to evaluate efficacy and safety in chemotherapy-induced neutropenia of once-per-cycle Mecapegfilgrastim Injection(PEG-G-CSF) and daily G-CSF in Patients with lymphoma patients.', 'detailedDescription': 'This is a randomized, controlled study. A total of 170 lymphoma patients who are eligible are planned to randomized assigned into two groups to receive mecapegfilgrastim fixed dose of 6 mg or filgrastim 5 µg/kg/day during chemotherapy.\n\nThe primary endpoint is the duration of grade ≥3 neutropenia in cycle 1. The secondary endpoints include incidence of grade ≥3 neutropenia and febrile neutropenia (FN) in cycle 1-4, The pharmacoeconomics and safety profile are also evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18 to 75 years;\n2. Patients with primary malignant lymphoma confirmed by histopathology or immunomolecular biology and requiring treatment with multi-cycle high-intensity chemotherapy regimen;\n3. ECOG performance status ≤ 1;\n4. ANC ≥1.5×109/L, PLT≥80×109 /L, Hb≥ 75g/L, WBC ≥3.0×109/L;\n5. Subjects with pregnancy ability must agree to use reliable contraceptive measures from screening to 1 year after treatment;\n6. Patients must sign informed consent and be willing and able to comply with the requirements of visits, treatment, laboratory tests and other research requirements stipulated in the research schedul.\n\nExclusion Criteria:\n\n1. Lymphoma central involvement;\n2. Recipients of hematopoietic stem cell transplantation or organ transplantation;\n3. Currently conducting clinical trials of other drugs;\n4. There is an uncontrollable infection with body temperature ≥38℃;\n5. liver function examination: total bilirubin (TBIL., alanine aminotransferase (ALT. and ascetic aminotransferase (AST. were all 2.5 times the upper limit of the normal value of \\>; if they were caused by liver metastasis, the upper limit of the normal value of \\> was 5 times;Renal function test: serum creatinine (Cr. \\>2 times the upper limit of normal value\n6. Patients with serious chronic diseases of heart, kidney, liver and other important organs;\n7. Patients with severe uncontrolled diabetes;\n8. Pregnant or lactating female patients.'}, 'identificationModule': {'nctId': 'NCT04460508', 'briefTitle': 'Mecapegfilgrastim(PEG-G-CSF) for Prophylaxis of Chemotherapy-induced Neutropenia in Patients With Lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'The First Hospital of Jilin University'}, 'officialTitle': 'Efficacy and Safety of Mecapegfilgrastim(PEG-G-CSF) for Prophylaxis of Chemotherapy-induced Neutropenia in Patients With Lymphoma: a Randomized, Open-label, Active-controlled Trial', 'orgStudyIdInfo': {'id': 'mecapegfilgrastim-lym-2020-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mecapegfilgrastim', 'description': 'Patients were administered pegylated rhG-CSF 6mg once at the 3rd day of every chemotherapy cycle.', 'interventionNames': ['Drug: Pegylated rhG-CSF']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'rhG-CSF', 'description': 'Patients were administered pegylated rhG-CSF 6 ug/kg/day from the 3rd day of every chemotherapy cycle.', 'interventionNames': ['Drug: rhG-CSF']}], 'interventions': [{'name': 'Pegylated rhG-CSF', 'type': 'DRUG', 'description': 'Pegylated rhG-CSF:6mg', 'armGroupLabels': ['Mecapegfilgrastim']}, {'name': 'rhG-CSF', 'type': 'DRUG', 'description': 'rhG-CSF:5ug/kg/d', 'armGroupLabels': ['rhG-CSF']}]}, 'contactsLocationsModule': {'locations': [{'zip': '130021', 'city': 'Changchun', 'state': 'Jilin', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ou BAI, doctor', 'role': 'CONTACT', 'email': 'oubai16@163.com', 'phone': '13039046656'}], 'facility': 'The First Bethune Hospital of Jilin University', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Hospital of Jilin University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ou Bai, MD/PHD', 'investigatorAffiliation': 'The First Hospital of Jilin University'}}}}