Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-25 @ 9:34 PM
Study NCT ID:
NCT06136351
Status:
RECRUITING
Last Update Posted:
2023-11-29
First Post:
2023-09-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of the Zanubrutinib Given in Combination With Bendamustine and Rituximab in (Elderly or TP53 Alterations or Chemotherapy Intolerance) Patients With Newly Diagnosed Mantle Cell Lymphoma
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': 'D000069461', 'term': 'Bendamustine Hydrochloride'}], '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': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 23}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2027-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-24', 'studyFirstSubmitDate': '2023-09-25', 'studyFirstSubmitQcDate': '2023-11-14', 'lastUpdatePostDateStruct': {'date': '2023-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '2-year Progression-Free Survival', 'timeFrame': '2 years', 'description': 'Progression-free survival was defined as the time from the date of first treatment until the date of the first documented day of disease progression or relapse, according to 2014 Lugano criteria, or death from any cause, whichever occurred first.'}], 'secondaryOutcomes': [{'measure': 'ORR', 'timeFrame': 'End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=28 days]', 'description': 'Objective Remission Rate (ORR) is defined as the proportion of patients with complete remission (CR) and partial remission (PR)'}, {'measure': 'CRR', 'timeFrame': 'End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=28 days]', 'description': 'Complete Remission Rate (CRR) is defined as the proportion of patients with CR'}, {'measure': 'OS', 'timeFrame': 'Baseline up to data cut-off (up to approximately 2 years)', 'description': 'Overall survival (OS) refers to the time from receiving the first dose to death from any cause'}, {'measure': 'Adverse Events', 'timeFrame': 'Baseline up to data cut-off (up to approximately 2 years)', 'description': 'Any harmful reaction that occurs during the treatment of a disease according to the normal usage and dosage of a drug, which is unrelated to the purpose of treatment.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lymphoma, Mantle-Cell']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of Zanubrutinib given in combination with bendamustine and rituximab in (elderly or TP53 alterations or chemotherapy intolerance) patients with newly diagnosed mantle cell lymphoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 18 years\n\n * Histopathologically confirmed mantle cell lymphoma according to the 5th edition of the World Health Organization (WHO)\n * FISH with del(17p)/TP53 mutation or ≥65 years; or\\<65 years but chemotherapy intolerance;\n * Life expectancy of \\> 3 months (in the opinion of the investigator);\n * Creatinine Clearance Rate (CCR) ≥ 50 mL/min or estimated Glomerular Filtration ●Rate (eGFR) ≥ 60 mL/(min·1.73 m\\^2);\n * International Normalized Ratio (INR) ≤ 1.5 and activated Partial Thromboplastin Time (aPTT) ≤ 1.5 times the upper limit of normal;\n * Left Ventricular Ejection Fraction (LVEF) ≥ 50%;\n * Agreeing to provide written informed consent prior to any special examination or procedure for the research on their own or legal representative.\n\nExclusion Criteria:\n\n* Pregnant or lactating women;\n* Known Hepatitis B Virus (HBV) and/or Hepatitis C Virus (HCV) infection (HBV infection refers to HBV-DNA \\> detectable limit);\n* With acquired or congenital immunodeficiency;\n* With congestive heart failure in 6 months before enrollment, New York Heart Association (NYHA) heart function class III or IV, or LVEF \\< 50%;\n* Known to be allergic to the test drug ingredients;\n* Diagnosed with or being treated for malignancy other than lymphoma;\n* With severe infection;\n* Substance abuse, medical, psychological, or social conditions that may interfere with the subjects' participation in the study or evaluation of the study results;\n* Deemed unsuitable for the group."}, 'identificationModule': {'nctId': 'NCT06136351', 'briefTitle': 'A Study of the Zanubrutinib Given in Combination With Bendamustine and Rituximab in (Elderly or TP53 Alterations or Chemotherapy Intolerance) Patients With Newly Diagnosed Mantle Cell Lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'Ruijin Hospital'}, 'officialTitle': 'A Study of the Zanubrutinib Given in Combination With Bendamustine and Rituximab in (Elderly or TP53 Alterations or Chemotherapy Intolerance) Patients With Newly Diagnosed Mantle Cell Lymphoma', 'orgStudyIdInfo': {'id': 'ZBR-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ZBR', 'interventionNames': ['Drug: Zanubrutinib', 'Drug: Rituximab', 'Drug: Bendamustin']}], 'interventions': [{'name': 'Zanubrutinib', 'type': 'DRUG', 'description': '160 mg bid po, until disease progression, intolerance of drug toxicity or death, otherwise maintaining during the 2 years of follow-up', 'armGroupLabels': ['ZBR']}, {'name': 'Rituximab', 'type': 'DRUG', 'description': '375 mg/m\\^2 ivgtt, D0 of each 28-day cycle', 'armGroupLabels': ['ZBR']}, {'name': 'Bendamustin', 'type': 'DRUG', 'description': '90mg/m\\^2 ivgtt, D0 of each 28-day cycle', 'armGroupLabels': ['ZBR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200020', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Weili ZHAO', 'role': 'CONTACT', 'email': 'zwl_trial@163.com', 'phone': '+862164370045', 'phoneExt': '610707'}], 'facility': 'Ruijin Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ruijin Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Zhao Weili', 'investigatorAffiliation': 'Ruijin Hospital'}}}}