Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2025-12-26 @ 3:34 AM
Study NCT ID:
NCT05466318
Status:
RECRUITING
Last Update Posted:
2022-07-25
First Post:
2022-07-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ChiCGB vs BEAM in High-risk or R/R Lymphomas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}, {'id': 'D016399', 'term': 'Lymphoma, T-Cell'}], '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': 'C547816', 'term': 'N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide'}, {'id': 'D017338', 'term': 'Cladribine'}, {'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D002066', 'term': 'Busulfan'}, {'id': 'D002330', 'term': 'Carmustine'}, {'id': 'D005047', 'term': 'Etoposide'}, {'id': 'D003561', 'term': 'Cytarabine'}, {'id': 'D008558', 'term': 'Melphalan'}], 'ancestors': [{'id': 'D015762', 'term': '2-Chloroadenosine'}, {'id': 'D000241', 'term': 'Adenosine'}, {'id': 'D011684', 'term': 'Purine Nucleosides'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003839', 'term': 'Deoxyadenosines'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D002072', 'term': 'Butylene Glycols'}, {'id': 'D006018', 'term': 'Glycols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D008698', 'term': 'Mesylates'}, {'id': 'D000476', 'term': 'Alkanesulfonates'}, {'id': 'D017738', 'term': 'Alkanesulfonic Acids'}, {'id': 'D000473', 'term': 'Alkanes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013451', 'term': 'Sulfonic Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009607', 'term': 'Nitrosourea Compounds'}, {'id': 'D014508', 'term': 'Urea'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009603', 'term': 'Nitroso Compounds'}, {'id': 'D011034', 'term': 'Podophyllotoxin'}, {'id': 'D013764', 'term': 'Tetrahydronaphthalenes'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D001087', 'term': 'Arabinonucleosides'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D010649', 'term': 'Phenylalanine'}, {'id': 'D024322', 'term': 'Amino Acids, Aromatic'}, {'id': 'D000598', 'term': 'Amino Acids, Cyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 306}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-21', 'studyFirstSubmitDate': '2022-07-17', 'studyFirstSubmitQcDate': '2022-07-17', 'lastUpdatePostDateStruct': {'date': '2022-07-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression free survival (PFS)', 'timeFrame': '2 years', 'description': 'Progression free survival of this group of patients at the end of 2 year'}], 'secondaryOutcomes': [{'measure': 'Overall survival (OS)', 'timeFrame': '2 years', 'description': 'Overall survival of this group of patients at the end of 2 year'}, {'measure': '100 day adverse events (AE)', 'timeFrame': '100 days from transplant', 'description': 'non-hematologic adverse events @ Day +100'}, {'measure': '100 day complete response (CR) rate', 'timeFrame': '100 days from transplant', 'description': 'Complete response @ Day +100'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lymphoma, Large B-Cell, Diffuse', 'Lymphoma, T-Cell']}, 'descriptionModule': {'briefSummary': 'High-dose chemotherapy (HDT) with autologous stem cell transplantation (ASCT) plays a vital role in treating high-risked or relapsed/refractory lymphoma. Our previous study showed chidamide combined with cladribine, gemcitabine, and busulfan (ChiCGB) as conditioning therapy improved the survival of these patients. So we designed this trial to verify if ChiCGB were better than BCNU, etoposide, cytarabine, and melphalan (BEAM). Patients with diffuse large B cell or extra-nodal NK/T cell Lymphoma who consent to this study will be randomized into the trial group who receive ChiCGB or the control group whom receive BEAM. Patients will be followed for up to 2 years after the hematopoietic cell transplantation (HCT).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with primary refractory or recurrent diffuse large B cell lymphoma or extra-nodal NK/T cell lymphoma that do not qualify for treatment protocols of higher priority.\n* Relapsed patients should respond to 2nd or 3rd line salvage chemotherapy and attain at least partial response before recruitment.\n* Adequate renal function, as defined by estimated serum creatinine clearance \\>/=50 ml/min and/or serum creatinine \\</= 1.8 mg/dL.\n* Adequate hepatic function, as defined by serum glutamate oxaloacetate transaminase (SGOT) and/or serum glutamate pyruvate transaminase (SGPT) \\</= 3 x upper limit of normal; serum bilirubin and alkaline phosphatase \\</= 2 x upper limit of normal.\n* Adequate pulmonary function with forced expiratory volume at one second (FEV1), forced vital capacity (FVC) and diffusing capacity of lung for carbon monoxide (DLCO) \\>/= 50% of expected corrected for hemoglobin.\n* Adequate cardiac function with left ventricular ejection fraction \\>/= 50%. No uncontrolled arrhythmias or symptomatic cardiac disease.\n* Performance status 0-1. 10. Negative Beta diffusing capacity of the lung for carbon monoxide (HCG) text in a woman with child-bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization\n\nExclusion Criteria:\n\n* Central nervous system lymphoma\n* Patients relapsed after autologous stem cell transplantation\n* Bone marrow was involved by lymphoma\n* Patients with active hepatitis B or C(HBV DNA \\>/=10,000 copies/mL).\n* Active infection requiring parenteral antibiotics\n* HIV infection, unless the patient is receiving effective antiretroviral therapy with undetectable viral load and a normal cluster of differentiation 4 (CD4) counts\n* Evidence of either cirrhosis or stage 3-4 liver fibrosis in patients with chronic hepatitis C or positive hepatitis C serology.\n* Patients with a corrected QT interval(QTc) longer than 500 ms'}, 'identificationModule': {'nctId': 'NCT05466318', 'briefTitle': 'ChiCGB vs BEAM in High-risk or R/R Lymphomas', 'organization': {'class': 'OTHER', 'fullName': 'Sichuan University'}, 'officialTitle': 'ChiCGB Versus BEAM With Autologous Stem-Cell Transplantation in High-risk Hodgkin and Non-Hodgkin Lymphoma - A Prospective, Multi-centered, Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'ChiCGB 2.0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ChiCGB', 'description': 'Treated with chidamide, cladribine, gemcitabine and busulfan(ChiCGB) therapy followed by autologous hematopoietic stem cell transplantation.', 'interventionNames': ['Drug: Chidamide', 'Drug: Cladribine', 'Drug: Gemcitabine', 'Drug: Busulfan', 'Procedure: Autologous hematopoietic stem cell transplant']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'BEAM', 'description': 'Treated with BCNU, etoposide, cytarabine and melphalan (BEAM) therapy followed by autologous hematopoietic stem cell transplantation.', 'interventionNames': ['Drug: Carmustine', 'Drug: Etoposide', 'Drug: Cytarabine', 'Drug: Melphalan', 'Procedure: Autologous hematopoietic stem cell transplant']}], 'interventions': [{'name': 'Chidamide', 'type': 'DRUG', 'description': '30 mg oral twice weekly for 2 weeks', 'armGroupLabels': ['ChiCGB']}, {'name': 'Cladribine', 'type': 'DRUG', 'description': '6 mg/m2 intravenously once daily @ Day -7 \\~ -3', 'armGroupLabels': ['ChiCGB']}, {'name': 'Gemcitabine', 'type': 'DRUG', 'description': '2500 mg/m2 intravenously @ Day -7, -3', 'armGroupLabels': ['ChiCGB']}, {'name': 'Busulfan', 'type': 'DRUG', 'description': '3.2 mg/kg intravenously once daily @ Day -7 \\~ -4', 'armGroupLabels': ['ChiCGB']}, {'name': 'Carmustine', 'type': 'DRUG', 'description': '300 mg/m2 intravenously @ Day -8', 'armGroupLabels': ['BEAM']}, {'name': 'Etoposide', 'type': 'DRUG', 'description': '200 mg/m2 intravenously once daily @ Day -7 \\~ -4', 'armGroupLabels': ['BEAM']}, {'name': 'Cytarabine', 'type': 'DRUG', 'description': '400 mg/m2 intravenously once daily @ Day -7 \\~ -4', 'armGroupLabels': ['BEAM']}, {'name': 'Melphalan', 'type': 'DRUG', 'description': '140 mg/m2 intravenously @ Day -3', 'armGroupLabels': ['BEAM']}, {'name': 'Autologous hematopoietic stem cell transplant', 'type': 'PROCEDURE', 'description': 'autologous hematopoietic stem cells infusion after ChiCGB or BEAM chemotherapy', 'armGroupLabels': ['BEAM', 'ChiCGB']}]}, 'contactsLocationsModule': {'locations': [{'zip': '618000', 'city': 'Deyang', 'state': 'Deyang', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jie Zhou, MD', 'role': 'CONTACT', 'email': 'JieZhou@163.com', 'phone': '86-0838-2418820'}], 'facility': "People's Hospital of Deyang City", 'geoPoint': {'lat': 31.13019, 'lon': 104.38198}}, {'zip': '610015', 'city': 'Chengdu', 'state': 'Sichuan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jing Tan, MD', 'role': 'CONTACT', 'email': 'JingT@sina.com', 'phone': '86-28-84446038'}], 'facility': "Chengdu Third People's Hospital", 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '610041', 'city': 'Chengdu', 'state': 'Sichuan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jie Ji, MD', 'role': 'CONTACT', 'email': 'jijie@wchscu.cn', 'phone': '86-28-85422373'}], 'facility': 'West China Hospital, Sichuan University', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '610071', 'city': 'Chengdu', 'state': 'Sichuan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Kaiji Zhang, MD', 'role': 'CONTACT', 'email': 'kaijiZ@163.com', 'phone': '+86 028-85311726'}], 'facility': "Chengdu First People's Hospital", 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '610083', 'city': 'Chengdu', 'state': 'Sichuan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hai Yi, MD', 'role': 'CONTACT', 'email': 'HaiYiCD@163.com', 'phone': '86-028-86570211'}], 'facility': 'PLA Western Theater Command General Hospital', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '635000', 'city': 'Dazhou', 'state': 'Sichuan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yaqiong Li, MD', 'role': 'CONTACT', 'email': 'yqli@163.com', 'phone': '86-0818-2371651'}], 'facility': 'Dazhou Central Hospital', 'geoPoint': {'lat': 31.2106, 'lon': 107.46308}}, {'zip': '646000', 'city': 'Luzhou', 'state': 'Sichuan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hongyun Xing, MD', 'role': 'CONTACT', 'email': 'hyxing@gmail.com', 'phone': '86-0830-3161222'}], 'facility': 'Southwest Medical University', 'geoPoint': {'lat': 28.8903, 'lon': 105.42575}}, {'zip': '621000', 'city': 'Mianyang', 'state': 'Sichuan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Fang Xu, MD', 'role': 'CONTACT', 'email': 'DrFangX@163.com', 'phone': '+86 816 222 2566'}], 'facility': 'Central Hospital of Mianyang City', 'geoPoint': {'lat': 31.46784, 'lon': 104.68168}}, {'zip': '637000', 'city': 'Nanchong', 'state': 'Sichuan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xingli Zou, MD', 'role': 'CONTACT', 'email': 'XingliZ@sina.com', 'phone': '86-0817-2239379'}], 'facility': 'Affiliated Hospital of North Sichuan Medical College', 'geoPoint': {'lat': 30.79508, 'lon': 106.08473}}, {'zip': '643011', 'city': 'Zigong', 'state': 'Sichuan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jian Xiao, MD', 'role': 'CONTACT', 'email': 'xiaojian@163.com', 'phone': '+86 813 210 0694'}], 'facility': "Zigong First People's Hospital", 'geoPoint': {'lat': 29.34162, 'lon': 104.77689}}, {'zip': '628099', 'city': 'Guangyuan', 'state': 'Sihcuan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ying Yuan, MD', 'role': 'CONTACT', 'email': 'dryingyuan@163.com', 'phone': '86-0839-3611120'}], 'facility': 'Guangyuan Central Hospital', 'geoPoint': {'lat': 32.44201, 'lon': 105.823}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'after the publication of results of this trial', 'ipdSharing': 'YES', 'description': 'Release after the publication of results of this trial'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sichuan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Jie Ji', 'investigatorAffiliation': 'Sichuan University'}}}}