Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-27 @ 11:41 PM
Study NCT ID:
NCT06757894
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-03
First Post:
2024-12-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Zuberitamab Combined with Bendamustine, Followed by Monotherapy Maintenance, in Treatment-naïve Follicular Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008224', 'term': 'Lymphoma, Follicular'}], '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': 'D000069461', 'term': 'Bendamustine Hydrochloride'}], 'ancestors': [{'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': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2034-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-28', 'studyFirstSubmitDate': '2024-12-27', 'studyFirstSubmitQcDate': '2024-12-28', 'lastUpdatePostDateStruct': {'date': '2025-01-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete Response (CR)', 'timeFrame': 'Up to 6 cycles (each cycle is 28 days).', 'description': 'Defined as the proportion of patients who achieve complete remission at the end of induction therapy.'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'Up to 6 cycles (each cycle is 28 days).', 'description': 'The proportion of patients who achieve complete remission (CR) or partial remission (PR) at the end of induction therapy.'}, {'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'From the start of induction therapy to the first documented disease progression or death from any cause, whichever occurs first, assessed up to 78 months.', 'description': 'The length of time during and after treatment that a patient lives with cancer without it getting worse or progressing.'}, {'measure': 'Event-Free Survival (EFS)', 'timeFrame': 'From the start of induction therapy to the first occurrence of any event, including disease progression, discontinuation of treatment, or death for any reason, whichever occurs first, assessed up to 78 months.', 'description': 'The length of time during and after treatment during which a patient remains free from any of the following events: disease progression, treatment discontinuation for any reason, or death from any cause.'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'From the first documentation of CR or PR to the first documented disease progression, assessed up to 78 months.', 'description': "The length of time during and after treatment that a patient's disease remains under control or in remission. It is the period from the first documentation of a response (such as partial or complete remission) until disease progression or relapse occurs."}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'From the start of induction therapy to death from any cause, assessed up to 78 months.', 'description': 'The length of time from the date of enrollment until death from any cause.'}, {'measure': 'Time to Next Treatment (TTNT)', 'timeFrame': 'From the start of induction therapy to the start of the next line of anti-tumor treatment, assessed up to 78 months.', 'description': 'The length of time from the initiation of a current treatment until the patient requires a subsequent line of therapy for the cancer.'}, {'measure': 'Incidence and severity of Adverse Events (AE) and Serious Adverse Event (SAE)', 'timeFrame': 'From the start of induction therapy through the end of the maintenance therapy phase, up to 30 months.', 'description': 'The occurrence and intensity of undesirable or harmful effects experienced by patients associated with the use of a medical treatment or intervention during the clinical trial.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Follicular Lymphoma (FL)']}, 'descriptionModule': {'briefSummary': 'This is a prospective, single-arm, multicenter, phase ll clinical trial to evaluate the efficacy and safety of Zuberitamab and Bendamustine combination treatment in treatment-naïve follicular lymphoma patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Voluntary signing of informed consent.\n2. Age ≥ 18 years, no gender restriction.\n3. Histologically confirmed follicular lymphoma (grades 1-3a), CD20 positive by immunohistochemistry.\n4. No prior systemic treatment for FL.\n5. Ann Arbor stage III/IV, or stage II with bulky disease (bulky disease defined as a tumor diameter ≥ 7 cm).\n6. Presence of measurable lesions.\n7. Meeting any of the following criteria:\n\n 1. B symptoms: unexplained fever \\>38°C, night sweats, unexplained weight loss \\>10% in the last 6 months.\n 2. Abnormal signs: splenomegaly, pleural effusion, ascites, etc.\n 3. Major organ damage: involvement of major organs leading to organ dysfunction.\n 4. Hematologic involvement: cytopenia \\[WBC \\< 1.0 × 10⁹/L and/or PLT \\< 100 × 10⁹/L\\]; leukemia-like manifestations (malignant cells \\> 5.0 × 10⁹/L); elevated LDH levels; HGB \\< 120 g/L; β2-microglobulin ≥ 3 mg/L.\n 5. Bulky disease: involvement of ≥ 3 tumors with each diameter ≥ 3 cm, or any lymph node or extranodal tumor with diameter ≥ 7 cm (for Ann Arbor stage III-IV patients).\n 6. Tumor enlargement of 20%-30% within 2-3 months, or approximately 50% enlargement within 6 months.\n8. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.\n9. Expected survival of \\> 6 months.\n\nExclusion Criteria:\n\n1. History of allergy to any component of monoclonal antibodies or investigational drugs.\n2. Central nervous system involvement.\n3. History of previous malignant tumors.\n4. Clinically significant cardiac or pulmonary diseases.\n5. Infection requiring intravenous antibiotic treatment or hospitalization within 4 weeks prior to enrollment; or infection requiring oral antibiotics within 2 weeks prior to enrollment; or symptoms related to an infection within 1 week prior to enrollment.\n6. Major surgery within 4 weeks prior to enrollment.\n7. Vaccination with live vaccines within 4 weeks prior to enrollment or planned live vaccination during the study.\n8. HIV antibody positive.\n9. Active syphilis infection, TP antibody positive, and anti-TP treatment within the last 2 years.\n10. Hepatitis C virus (HCV) antibody positive with HCV RNA quantitative test result exceeding the detection limit; Hepatitis B surface antigen (HBsAg) positive or Hepatitis B core antibody (HBcAb) positive, with Hepatitis B virus DNA quantitative test result exceeding the detection limit (for patients with HBsAg or HBcAb positive status, regardless of HBV-DNA detection, oral entecavir or other antiviral therapy must be initiated prior to enrollment and continued according to the physician's instructions during the trial).\n11. Pregnant or breastfeeding women, or planning to become pregnant during the study.\n12. Investigator determines the patient is unsuitable for enrollment or may not be able to complete the trial for other reasons."}, 'identificationModule': {'nctId': 'NCT06757894', 'briefTitle': 'Efficacy and Safety of Zuberitamab Combined with Bendamustine, Followed by Monotherapy Maintenance, in Treatment-naïve Follicular Lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Efficacy and Safety of Zuberitamab and Bendamustine Combination Treatment Followed by Monotherapy Maintenance in Treatment-naïve Follicular Lymphoma: an Open-label, Prospective, Multicenter, Single-arm Phase II Clinical Study', 'orgStudyIdInfo': {'id': 'B2024-815-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Zuberitamab and Bendamustine Combination Treatment', 'description': 'Induction therapy:\n\n1. Zuberitamab: 375 mg/m², administered on Day 1 (D1) of Cycles 1-6 (C1-C6).\n2. Bendamustine: 90 mg/m², administered on D1-2 of C1-C6. Each cycle lasts 28 days. After 6 cycles of treatment, patients who achieve complete remission (CR) or partial remission (PR) will continue with maintenance therapy.\n\nMaintenance therapy:\n\nZuberitamab: 375 mg/m², administered once every 2 months, until disease progression or for a maximum of 24 months (12 doses).', 'interventionNames': ['Drug: Zuberitamab', 'Drug: Bendamustine']}], 'interventions': [{'name': 'Zuberitamab', 'type': 'DRUG', 'description': '375 mg/m², administered on Day 1 (D1) of Cycles 1-6 (C1-C6)', 'armGroupLabels': ['Zuberitamab and Bendamustine Combination Treatment']}, {'name': 'Bendamustine', 'type': 'DRUG', 'description': '90 mg/m², administered on D1-2 of C1-C6', 'armGroupLabels': ['Zuberitamab and Bendamustine Combination Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510060', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'contacts': [{'name': 'Qingqing Cai, MD. PhD.', 'role': 'CONTACT', 'email': 'caiqq@sysucc.org.cn', 'phone': '0086-20-87342823'}], 'facility': 'Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Qingqing Cai, MD. PhD.', 'role': 'CONTACT', 'email': 'caiqq@sysucc.org.cn', 'phone': '02087342823'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Gansu Cancer Hospital', 'class': 'OTHER'}, {'name': 'Ganzhou Cancer Hospital', 'class': 'UNKNOWN'}, {'name': 'Fifth Affiliated Hospital, Sun Yat-Sen University', 'class': 'OTHER'}, {'name': 'Fifth Affiliated Hospital of Guangzhou Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'chief physician', 'investigatorFullName': 'Qingqing Cai', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}