Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 10:26 PM
Study NCT ID:
NCT04624958
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-10-18
First Post:
2020-11-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Zanubrutinib and Rituximab Followed by R-DHAOx Then Maintenance with Zanubrutinib for Newly-Diagnosed MCL
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020522', 'term': 'Lymphoma, Mantle-Cell'}], 'ancestors': [{'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': 'C000629551', 'term': 'zanubrutinib'}, {'id': 'D000069283', 'term': 'Rituximab'}, {'id': 'D016345', 'term': 'Medicare Part B'}], 'ancestors': [{'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': 'D006278', 'term': 'Medicare'}, {'id': 'D008483', 'term': 'Medical Assistance'}, {'id': 'D011632', 'term': 'Public Assistance'}, {'id': 'D005380', 'term': 'Financing, Government'}, {'id': 'D005381', 'term': 'Financing, Organized'}, {'id': 'D004467', 'term': 'Economics'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}, {'id': 'D007348', 'term': 'Insurance, Health'}, {'id': 'D007341', 'term': 'Insurance'}, {'id': 'D007878', 'term': 'Legislation as Topic'}, {'id': 'D012926', 'term': 'Social Control, Formal'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-16', 'studyFirstSubmitDate': '2020-11-06', 'studyFirstSubmitQcDate': '2020-11-06', 'lastUpdatePostDateStruct': {'date': '2024-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete remission rate after PART A', 'timeFrame': '3 years', 'description': 'Complete remission rate will be determined on the basis of investigator assessments according to 2014 Lugano criteria.'}], 'secondaryOutcomes': [{'measure': 'Complete remission rate after study treatment', 'timeFrame': '3 years', 'description': 'Complete remission rate will be determined on the basis of investigator assessments according to 2014 Lugano criteria.'}, {'measure': 'Objective Response rate', 'timeFrame': '3 years', 'description': 'Objective Response rate will be determined on the basis of investigator assessments according to 2014 Lugano criteria.'}, {'measure': 'Progression Free Survival', 'timeFrame': '5 years', 'description': 'The time from the start of treatment to the progression of the tumor or death (due to any cause).'}, {'measure': 'Overall Survival', 'timeFrame': '5 years', 'description': 'The time from the start of treatment to time of death (due to any cause).'}, {'measure': 'Time to Response', 'timeFrame': '3 years', 'description': 'The time from the start of treatment to the first assessment of complete remission or partial remission.'}, {'measure': 'Duration of Response', 'timeFrame': '5 years', 'description': 'The time from the first assessment of complete remission or partial remission to progressive disease or death (due to any cause).'}, {'measure': 'Percentage of Participants With Adverse Events', 'timeFrame': '3 years', 'description': 'Adverse Events will be determined and graded on the basis of investigator assessments according to NCI CTC AE 5.0'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mantle Cell Lymphoma', 'Newly-diagnosed Mantle Cell Lymphoma']}, 'descriptionModule': {'briefSummary': 'This phase 2 trial studies the efficacy and safety of zanubrutinib plus rituximab followed by R-DHAOx (rituximab, dexamethasone, cytarabine and oxaliplatin) regimen then maintenance with zanubrutinib for newly-diagnosed Mantle Cell Lymphoma (MCL).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed CD20 positive mantle cell lymphoma;\n* Patients with MCL-related symptomatic and need immediate therapy; Include any of the following: (1) Blastoid variant (2) Pleomorphic variant (3) Ki-67 ≥30% (4) Bulky mass \\> 7 cm or ≥2 tumors, each ≥5 cm in diameter (5) Mutations in TP53, c-MYC or NOTCH genes (6) Size of spleen ≥20 cm (7) Lymphoma B symptoms (8) Mantle Cell International Prognostic Score (MIPI) \\> 3 (9) Lymphoma threatening organ function (10) Elevated lactate dehydrogenase (11) Peripheral blood white blood cell \\> 50×10\\^9/L (12) Pancytopenia due to bone marrow involvement (13) Pain due to lymphoma;\n* Patients received no prior anti-lymphoma treatment;\n* At least one evaluable lesion according to 2014 Lugano criteria;\n* Ann Arbor stage II-IV;\n* Eastern Cooperative Oncology Group (ECOG) of 0-2;\n* Life expectancy \\> 3 months;\n* Able to participate in all required study procedures;\n* Proper functioning of the major organs: 1) The absolute value of neutrophils (\\>1.5×10\\^9/L); 2) platelet count (\\> 75×10\\^9/L); 3) Hemoglobin (\\> 80 g/L); 4) Serum creatinine \\<1.5 times Upper Limit Normal (ULN) ; 5) Serum total bilirubin \\< 1.5 times ULN; 6) Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) \\< 2.5 times ULN; 7) Coagulation function: International Normalized Ratio (INR), Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT) \\< 1.5 times ULN (unless the subject is receiving anticoagulant therapy and PT and APTT are within the expected range at screening time);\n\nExclusion Criteria:\n\n* Involvement of central nervous system (CNS)\n* Patients with Hemophagocytic syndrome;\n* Patients with active bleeding, bleeding tendency or require anticoagulation treatment;\n* Patients require treatment with strong CYP3A inhibitors;\n* Uncontrolled active infection, with the exception of tumor-related B symptom fever;\n* History of human immunodeficiency virus (HIV) infection and/or patients with acquired immunodeficiency syndrome are known;\n* Patients with active hepatitis B or active hepatitis C. Patients who are positive for hepatitis B Surface Antigen (HBsAg) or hepatitis C Virus (HCV) antibodies at screening stage must pass further detection of hepatitis B Virus (HBV) DNA (no more than 1000 IU/mL) and HCV RNA (no more than the lower limit of the detection method) in the row. Hepatitis B carriers, stable hepatitis B (DNA titer should not be higher than 1000 IU/mL) after drug treatment, and cured hepatitis C patients can be enrolled in the group;\n* Diagnosed with or receiving treatment for malignancy other than lymphoma;\n* Pregnant or breastfeeding women;\n* Other researchers consider it unsuitable for patients to participate in this study.'}, 'identificationModule': {'nctId': 'NCT04624958', 'briefTitle': 'Zanubrutinib and Rituximab Followed by R-DHAOx Then Maintenance with Zanubrutinib for Newly-Diagnosed MCL', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Zanubrutinib and Rituximab Followed by R-DHAOx (Rituximab, Dexamethasone, Cytarabine and Oxaliplatin) Regimen Then Maintenance with Zanubrutinib for Newly-Diagnosed Mantle Cell Lymphoma (MCL): a Single Arm, Open Label, Multi-center Phase II Study', 'orgStudyIdInfo': {'id': 'B2020-232-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'zanubrutinib, rituximab, consolidation chemotherapy and zanubrutinb maintenance', 'description': 'Part A (Zanubrutinib and Rituximab): Patients receive zanubrutinib on days 1-28 and rituximab on day 1. Treatment cycles repeat every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity or until patients achieve CR.\n\nPART B (Consolidation chemotherapy of R-DHAOx): Patients receive R-DHAOx regimen every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Elderly patients (\\> 65 years old) and patients who achieved CR and minimal residual disease negative after PART B receive zanubrutinb maintenance therapy. Young patients (\\<65 years old) who achieved CR but minimal residual disease positive after PART B can receive autologous stem cell transplantation and then zanubrutinb maintenance therapy. Patients with PD, SD or PR after PART B quit the trial.\n\nZANUBRUTINB MAINTENANCE: Patients receive zanubrutinib every day for up to one year.', 'interventionNames': ['Drug: Zanubrutinib and Rituximab', 'Drug: R-DHAOx', 'Drug: Zanubrutinib Maintenance']}], 'interventions': [{'name': 'Zanubrutinib and Rituximab', 'type': 'DRUG', 'otherNames': ['PART A'], 'description': 'Zanubrutinb 160mg PO BID d1-28; Rituximab 375mg/m2 iv.drip d1.', 'armGroupLabels': ['zanubrutinib, rituximab, consolidation chemotherapy and zanubrutinb maintenance']}, {'name': 'R-DHAOx', 'type': 'DRUG', 'otherNames': ['PART B'], 'description': 'Rituximab 375mg/m2 iv.drip d1; Dexamethasone 20mg iv.drip d1-4; Cytarabine 2000mg/m2 (1000mg/m2 for patients aged over 65) iv.drip d2,3 Oxaliplatin 130mg/m2 iv.drip d1.', 'armGroupLabels': ['zanubrutinib, rituximab, consolidation chemotherapy and zanubrutinb maintenance']}, {'name': 'Zanubrutinib Maintenance', 'type': 'DRUG', 'description': 'Zanubrutinb 160mg PO BID.', 'armGroupLabels': ['zanubrutinib, rituximab, consolidation chemotherapy and zanubrutinb maintenance']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Guangdong General Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Sun Yat-sen University Cancer Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'The First Affiliated Hospital of Guangdong Pharmaceutical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Qingqing Cai, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sun Yat-sen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief physician', 'investigatorFullName': 'Qingqing Cai', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}