Ignite Creation Date:
2025-12-24 @ 5:44 PM
Ignite Modification Date:
2026-01-04 @ 5:02 PM
Study NCT ID:
NCT06244368
Status:
RECRUITING
Last Update Posted:
2025-05-14
First Post:
2024-01-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
GVM±R in Patients With Relapsed or Refractory Aggressive NHL.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016411', 'term': 'Lymphoma, T-Cell, Peripheral'}, {'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}], 'ancestors': [{'id': 'D016399', 'term': 'Lymphoma, T-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'}, {'id': 'D016393', 'term': 'Lymphoma, B-Cell'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 115}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2027-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-12', 'studyFirstSubmitDate': '2024-01-28', 'studyFirstSubmitQcDate': '2024-02-05', 'lastUpdatePostDateStruct': {'date': '2025-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Response Rate (ORR)', 'timeFrame': 'up to 2 years', 'description': 'Response is assessed according to the lugano criteria'}], 'secondaryOutcomes': [{'measure': 'Complete Response Rate (CRR)', 'timeFrame': 'up to 2 years', 'description': 'Response is assessed according to the lugano criteria'}, {'measure': 'Progression-Free-Survival (PFS)', 'timeFrame': 'up to 2 years', 'description': 'From the date of the first dose of therapy is given until disease progression, death or last follow-up'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'up to 2 years', 'description': 'From the date of inclusion to date of death, irrespective of cause'}, {'measure': 'Incidence of Treatment-Emergent Adverse Events', 'timeFrame': 'up to 2 years', 'description': 'The adverse events were evaluated by NCI-CTCAE 5.0 standard Hematologic and non-hematologic toxicity'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ["aggressive non-Hodgkin's lymphoma (NHL)", 'Mitoxantrone hydrochloride liposome', 'GVM±R'], 'conditions': ['Peripheral T Cell Lymphoma', 'Diffuse Large B-cell Lymphoma']}, 'descriptionModule': {'briefSummary': "This is a prospective clinical study to evaluate the safety and efficacy of GVM±R in patients with relapsed or refractory aggressive non-Hodgkin's lymphoma (NHL).", 'detailedDescription': 'This is a single-arm, open label, multi-center clinical study to evaluate the safety and efficacy of mitoxantrone hydrochloride liposome in combination with gemcitabine, vinorelbine and/or anti-CD20 monoclonal antibody(GVM ± R) in patients with relapsed or refractory aggressive non-Hodgkin lymphoma (NHL).Mitoxantrone hydrochloride liposome will be given on day 1 at dose of 18 mg/m2 and be combined with gemcitabine, vinorelbine and/or rituximab (Pts with CD20-positive lymphomas are evaluated by the investigator on whether to combine rituximab or choose another CD20 monoclonal antibody).Each cycle consists of 21 days. A maximum of 6 cycles of therapy are planned.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age ≥18, ≤65 years.\n2. Expected survival ≥ 3 months.\n3. Subjects with aggressive NHL who have relapsed or proven refractory to at least one line of standard therapy or have achieved PR as the best response after a minimum of 4 cycles of therapy (patients with a Deauville score of 4 must have biopsy-proven residual disease). Relapse is defined as a disease response (PR/CR) to the last-line therapy with a duration of response exceeding 6 months. Refractory disease can be confirmed under any of the following conditions: 1) no partial or complete response to the last-line therapy; 2) the duration of complete or partial response to the last-line therapy is no longer than 6 months from the last dose of therapy; 3) Recurrence after hematopoietic stem cell transplantation.\n4. Subjects must have at least one measurable lesion per lugano2014 criteria: for lymph node lesions, the long diameter should be \\> 1.5cm; For non-lymph node lesions, the long diameter should be \\> 1.0cm;\n5. Eastern Cooperative Oncology Group (ECOG) : 0-2\n6. Peripheral blood: Absolute neutrophil count (ANC) ≥1.5×109/L, Platelet count (PLT) ≥75×109/L, Hemoglobin(HB)≥ 80g/L.(Restriction may be relaxed in patients with bone marrow involvement, Absolute neutrophil count (ANC) ≥1.0×109/L, Platelet count (PLT) ≥50×109/L, Hemoglobin(HB)≥ 75g/L).\n7. Liver and kidney function: Serum creatinine (Scr) ≤1.5X upper limit of normal (ULN).Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5X ULN, Total bilirubin (TBIL) ≤1.5X upper limit of normal (ULN).(If the lymphoma involves the liver, TBIL≤3 X ULN.AST and ALT≤5 X ULN). For Pts diagnosed with Gilbert's disease, TBIL was enrolled if it was ≤3 X ULN.-\n\nExclusion Criteria:\n\n1. The subject had previously received any of the following anti-tumor treatments:\n\n 1. Subjects who have been treated with mitoxantrone or mitoxantrone liposomes;\n 2. Previously received doxorubicin or other anthracycline treatment, and the total cumulative dose of doxorubicin was more than 360 mg/m2 (For other anthracyclines, 1 mg doxorubicin equivalent to 2 mg epirubicin);\n 3. Subjects who received anti-tumor treatment (including chemotherapy, targeted therapy, glucocorticoid, traditional Chinese medicine with anti-tumor activity, etc.) or participated in other clinical trials and received trial drugs within 4 weeks or 5 half-lives((whichever comes first) before the first administration of the study drugs;\n 4. Subjects who received autologous hematopoietic stem cell transplantation or allogeneic hematopoietic stem cell transplantation within 100 days before the first administration of study drugs;\n 5. Subjects who received chimeric antigen receptor T-cell (CAR-T) therapy.\n2. Hypersensitivity to any study drug or its components.\n3. Uncontrolled systemic diseases (such as active infection, uncontrolled hypertension, diabetes, etc.)\n4. Heart function and disease meet one of the following conditions:\n\n 1. Long QTc syndrome or QTc interval \\> 480 ms;\n 2. Complete left bundle branch block, grade II or III atrioventricular block;\n 3. Serious and uncontrolled arrhythmias requiring drug treatment;\n 4. New York Heart Association grade ≥ III;\n 5. Left Ventricular Ejection Fractions (LVEF)\\< 50%;\n 6. A history of myocardial infarction, unstable angina pectoris, severe unstable ventricular arrhythmia or any other arrhythmia requiring treatment, a history of clinically serious pericardial disease, or ECG evidence of acute ischemia or active conduction system abnormalities within 6 months before recruitment.\n5. Active hepatitis B and C infection (defined as hepatitis B virus surface antigen positive and hepatitis B virus DNA higher than the Upper limit of normal(ULN); Hepatitis C virus antibody positive and hepatitis C virus RNA higher than the Upper limit of normal).\n6. Human immunodeficiency virus (HIV) infection (defined as HIV antibody positive).\n7. Patients with other malignant tumors, except for effectively controlled non-melanoma skin basal cell carcinoma, breast/cervical carcinoma in situ or other tumors without treatment during the past 5 years.\n8. Pregnant and lactating women and patients of childbearing age who are unwilling to take contraceptive measures.\n9. ≥ Grade 3 neuritis.\n10. Active central nervous system (CNS) lymphoma;\n11. Unsuitable subjects for this study determined by the investigator. -"}, 'identificationModule': {'nctId': 'NCT06244368', 'briefTitle': 'GVM±R in Patients With Relapsed or Refractory Aggressive NHL.', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Hematology & Blood Diseases Hospital, China'}, 'officialTitle': "A Single Arm, Open Label, Multi-center Study of Mitoxantrone Hydrochloride Liposome, Gemcitabine, Vinorelbine With or Without Anti-CD20 Monoclonal Antibody (GVM±R) in Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma", 'orgStudyIdInfo': {'id': 'IIT2023065'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GVM±R', 'description': 'Patients with relapsed or refractory aggressive NHL will undergo GVM±R therapy', 'interventionNames': ['Drug: GVM±R regimen']}], 'interventions': [{'name': 'GVM±R regimen', 'type': 'DRUG', 'description': 'Mitoxantrone hydrochloride liposome (18 mg/m\\^2) on day 1； Gemcitabine (800 mg/m\\^2) on day 1,8； Vinorelbine (20mg/m\\^2) on day 1,8； Rituximab (375mg/m\\^2) on day 1;\n\nThe regimen will be administered every 3 weeks, for a maximum of 6 cycles. The choice of CD20 monoclonal antibody will be determined by the attending physician.', 'armGroupLabels': ['GVM±R']}]}, 'contactsLocationsModule': {'locations': [{'zip': '300020', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wei Liu', 'role': 'CONTACT', 'email': 'liuwei@ihcams.ac.cn'}, {'role': 'CONTACT', 'email': 'liuwei@ihcams.ac.cn'}, {'name': 'Wei Liu', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Institute of Hematology & Blood Diseases Hospital, CAMS & PUMC', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'centralContacts': [{'name': 'Wei Liu', 'role': 'CONTACT', 'email': 'liuwei@ihcams.ac.cn', 'phone': '022-23608461'}], 'overallOfficials': [{'name': 'Wei Liu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute of Hematology & Blood Diseases Hospital, CAMS & PUMC'}, {'name': 'Xiaojing Yan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'First Hospital of China Medical University'}, {'name': 'HaiSheng、Chen Liu 、Huang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hebei Medical University Fourth Hospital'}, {'name': 'Yongqian Jia', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chengdu Shangjin Nanfu Hospital'}, {'name': 'Yunhong Huang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Affiliated Cancer Hospital & Institute of Guizhou Medical University'}, {'name': 'Xiaobo Wang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Second Affiliated Hospital of Dalian Medical University'}, {'name': 'Wanling Sun', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Xuanwu Hospital, Beijing'}, {'name': 'Mingxing Zhong', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Affiliated Ganzhou Hospital of Nanchang University'}, {'name': 'Liang Wang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Tongren Hospital'}, {'name': 'Xiuli Sun', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital of Dalian Medical University'}, {'name': 'Ou Bai', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Hospital of Jilin University'}, {'name': 'Shuxia Guo', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "People's Hospital of Zhengzhou University"}, {'name': 'Yanli Yang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital of Bengbu Medical University'}, {'name': 'Zeping Zhou', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Second Affiliated Hospital of Kunming Medical University'}, {'name': 'Fei Li', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital of Nanchang University'}, {'name': 'Aichun Liu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Second Affiliated Hospital of Harbin Medical University'}, {'name': 'Aijun Liao', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shengjing Hospital'}, {'name': 'Hongmei Jing', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University Third Hospital'}, {'name': 'Shuye Wang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'First Affiliated Hospital of Harbin Medical University'}, {'name': 'Zhenling Li', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'China-Japan Friendship Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Hematology & Blood Diseases Hospital, China', 'class': 'OTHER'}, 'collaborators': [{'name': 'First Hospital of China Medical University', 'class': 'OTHER'}, {'name': 'Hebei Medical University Fourth Hospital', 'class': 'OTHER'}, {'name': 'Chengdu Shangjin Nanfu Hospital', 'class': 'UNKNOWN'}, {'name': 'Affiliated Cancer Hospital & Institute of Guangzhou Medical University', 'class': 'OTHER'}, {'name': 'Xuanwu Hospital, Beijing', 'class': 'OTHER'}, {'name': 'The Affiliated Ganzhou Hospital of Nanchang University', 'class': 'OTHER'}, {'name': 'Beijing Tongren Hospital', 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital of Dalian Medical University', 'class': 'OTHER'}, {'name': 'The First Hospital of Jilin University', 'class': 'OTHER'}, {'name': "People's Hospital of Zhengzhou University", 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital of Bengbu Medical University', 'class': 'OTHER'}, {'name': 'The Second Affiliated Hospital of Kunming Medical University', 'class': 'OTHER'}, {'name': 'The First Affiliated Hospital of Nanchang University', 'class': 'OTHER'}, {'name': 'The Second Affiliated Hospital of Harbin Medical University', 'class': 'OTHER'}, {'name': 'Shengjing Hospital', 'class': 'OTHER'}, {'name': 'Peking University Third Hospital', 'class': 'OTHER'}, {'name': 'First Affiliated Hospital of Harbin Medical University', 'class': 'OTHER'}, {'name': 'China-Japan Friendship Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}