Ignite Creation Date:
2025-12-24 @ 11:20 PM
Ignite Modification Date:
2026-01-01 @ 10:01 AM
Study NCT ID:
NCT04433156
Status:
UNKNOWN
Last Update Posted:
2023-05-18
First Post:
2020-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
VR-CAP in the First-line Treatment for Patients With Marginal Zone Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018442', 'term': 'Lymphoma, B-Cell, Marginal Zone'}], 'ancestors': [{'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'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': 'D000069286', 'term': 'Bortezomib'}, {'id': 'D000069283', 'term': 'Rituximab'}, {'id': 'D015251', 'term': 'Epirubicin'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D011241', 'term': 'Prednisone'}], 'ancestors': [{'id': 'D001897', 'term': 'Boronic Acids'}, {'id': 'D000148', 'term': 'Acids, Noncarboxylic'}, {'id': 'D000143', 'term': 'Acids'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D001896', 'term': 'Boron Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011719', 'term': 'Pyrazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D058846', 'term': 'Antibodies, Monoclonal, Murine-Derived'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-04-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2025-04-22', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-17', 'studyFirstSubmitDate': '2020-06-11', 'studyFirstSubmitQcDate': '2020-06-13', 'lastUpdatePostDateStruct': {'date': '2023-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '2-year progression-free survival', 'timeFrame': "from the beginning day of the first cycle (each cycle is 21 days) of treatment to the date of confirmed progressive disease or death, whichever occurs first, up to 2 years after last patient's enrollment", 'description': 'the total proportion of patients with no progression from date of the first day of treatment to the date of confirmed progressive disease or death which one occurs first'}], 'secondaryOutcomes': [{'measure': 'objective response rate', 'timeFrame': "every 6 weeks from the beginning day of the first cycle (each cycle is 21 days) of induction chemotherapy treatment and every 8 weeks from the day of the first cycle of maintenance treatment to 18 months after last patient's enrollment", 'description': 'the total proportion of patients with complete response (CR) and partial response (PR)'}, {'measure': 'overall survival', 'timeFrame': 'from the beginning day of the first cycle (each cycle is 21 days) of treatment to the date of death from any cause, assessed up to 5 years', 'description': 'from date of first day of treatment to the date of death by any cause'}, {'measure': 'incidence and relationship with study drugs of grade 3-4 adverse events', 'timeFrame': "from the beginning day of the first cycle (each cycle is 21 days) of treatment to 6 months after last patient's enrollment", 'description': 'the incidence and relationship with study drugs of grade 3 or 4 adverse events (based on NCI CTC-AE v4.03'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Marginal Zone Lymphoma', 'VR-CAP'], 'conditions': ['Marginal Zone Lymphoma']}, 'descriptionModule': {'briefSummary': 'This is a prospective single arm, multi-center, phase II clinical trial to observe the efficacy and safety of VR-CAP (Bortezomib and Rituximab-Cyclophosphamide, Epirubicin and Prednisone) in the first-line treatment for patients with marginal zone lymphoma.', 'detailedDescription': "Marginal zone lymphoma (MZL) is a relatively common group of non-Hodgkin's lymphoma (NHL). The incidence rate is only inferior to diffuse large B cell lymphoma (DLBCL) and follicular lymphoma (FL). Currently, NCCN guidelines recommend same treatment plan of FL like R-CHOP as the primary treatment for MZL. However, due to the great difference in cell origin and biological characteristics between FL and MZL, some patients can not achieve complete remission or relapse quickly after standard first-line treatment. A number of phase II clinical studies have evaluated the good efficacy of rituximab combined with chemotherapy in the treatment of MZL. Previous studies have shown that NF-κB signaling pathway is in abnormal activation state in MZL. Bortezomib, a proteasome inhibitor targeting NF-κB pathway, has a promising therapeutic prospect in relapsed and refractory MZL. The goal of our trial is to assess the efficacy and safety of VR-CAP (Bortezomib and Rituximab-Cyclophosphamide, Epirubicin and Prednisone) in the first-line treatment for patients with marginal zone lymphoma."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age between 18 to 70 years old (including 18 and 70)\n2. Diagnosed as marginal zone lymphoma\n3. No receiving chemotherapy before enrollment\n4. Indications for treatment: 1) symptoms related to tumor; 2) end-organ function damage; 3) large mass; 4) continuous or rapid progress of disease; 5) patient's willingness\n5. Having at least one measurable lesions\n6. World health organization-Eastern Cooperative Oncology Group Performance tatus (ECOG) 0-1\n7. Life expectancy no less than 3 months\n8. enough main organ function\n9. Pregnancy test within 7 days must be negative for women of childbearing period, and appropriate measures should be taken for contraception for women in childbearing period during the study and six months after this study\n10. Agreeing to sign the written informed consents\n\nExclusion Criteria:\n\n1. Diagnosed as central nervous system lymphoma\n2. World health organization-Eastern Cooperative Oncology Group Performance tatus (ECOG) ≥2\n3. Other malignant tumor history or active malignant tumor need be treated\n4. Serious surgery and trauma less than two weeks\n5. Systemic therapy for serious acute/chronic infection\n6. Congestive heart failure, uncontrolled coronary heart disease, arrhythmia and heart infarction less than 6 months\n7. Active tuberculosis. Patients suspected of active TB need to be examined for chest X-ray, sputum and clinical symptoms and signs\n8. HIV-positive, AIDS patients and untreated active hepatitis（HBV/HBV and HCV）\n9. Patients with a history of deep vein thrombosis or pulmonary embolism less than 12 months\n10. Patients with a history of mental illness\n11. Researchers determine unsuited to participate in this trial"}, 'identificationModule': {'nctId': 'NCT04433156', 'briefTitle': 'VR-CAP in the First-line Treatment for Patients With Marginal Zone Lymphoma', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Henan Cancer Hospital'}, 'officialTitle': 'A Single Arm, Multi-center, Phase II Clinical Trial of VR-CAP in the First-line Treatment for Patients With Marginal Zone Lymphoma', 'orgStudyIdInfo': {'id': 'HNSZLYYNHL03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VR-CAP', 'description': 'Rituximab, 375 mg/m2, Intravenous administration on day 0, Bortezomib, 1.3 mg/m2 hypodermic injection on day 1 and 4, combined with regimen: Cyclophosphamide, Epirubicin, and Prednisone: repeated every 3 weeks, up to 6 cycles.', 'interventionNames': ['Drug: Bortezomib', 'Drug: Rituximab', 'Drug: Epirubicin', 'Drug: Cyclophosphamide', 'Drug: Prednisone']}], 'interventions': [{'name': 'Bortezomib', 'type': 'DRUG', 'otherNames': ['Bortezomib Injection'], 'description': '1.3 mg/m2, hypodermic injection on day 1 and day 4 of each 3-week cycle until disease progression/stable disease after 2/4 cycles treatment or unacceptable toxicity develops, up to 6 cycles.', 'armGroupLabels': ['VR-CAP']}, {'name': 'Rituximab', 'type': 'DRUG', 'otherNames': ['RiTUXimab Injection'], 'description': '375 mg/m2, Intravenous administration on day 0 of each 3-week cycle until disease progression/stable disease after 2/4 cycles treatment or unacceptable toxicity develops, up to 6 cycles.', 'armGroupLabels': ['VR-CAP']}, {'name': 'Epirubicin', 'type': 'DRUG', 'otherNames': ['Epirubicin hydrochloride'], 'description': '70 mg/m2, Intravenous administration on day 1 of each 3-week cycle until disease progression/stable disease after 2/4 cycles treatment or unacceptable toxicity develops, up to 6 cycles.', 'armGroupLabels': ['VR-CAP']}, {'name': 'Cyclophosphamide', 'type': 'DRUG', 'otherNames': ['Cyclophosphamide Injection'], 'description': '750 mg/m2, Intravenous administration on day 1 of each 3-week cycle until disease progression/stable disease after 2/4 cycles treatment or unacceptable toxicity develops, up to 6 cycles.', 'armGroupLabels': ['VR-CAP']}, {'name': 'Prednisone', 'type': 'DRUG', 'otherNames': ['Prednisone Oral Product'], 'description': '100mg, oral administration on day 1 to 5 of each 3-week cycle until disease progression/stable disease after 2/4 cycles treatment or unacceptable toxicity develops, up to 6 cycles', 'armGroupLabels': ['VR-CAP']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Zhengzhou', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yanyan Liu, M.D. Ph.D', 'role': 'CONTACT', 'email': 'yyliu@zzu.edu.cn', 'phone': '+8613818176375'}, {'name': 'Yanyan Liu, M.D. Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}], 'centralContacts': [{'name': 'Yanyan Liu, M.D. Ph.D', 'role': 'CONTACT', 'email': 'yyliu@zzu.edu.cn', 'phone': '+8613818176375'}], 'overallOfficials': [{'name': 'Yanyan Liu, M.D. Ph.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Henan Cancer Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Henan Cancer Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Yanyan Liu', 'investigatorAffiliation': 'Henan Cancer Hospital'}}}}