Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2025-12-27 @ 1:32 PM
Study NCT ID:
NCT03598959
Status:
UNKNOWN
Last Update Posted:
2018-07-26
First Post:
2018-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tofacitinib Combined With Chidamide in R/R ENKTCL
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054391', 'term': 'Lymphoma, Extranodal NK-T-Cell'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C479163', 'term': 'tofacitinib'}, {'id': 'C547816', 'term': 'N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-07-24', 'studyFirstSubmitDate': '2018-07-16', 'studyFirstSubmitQcDate': '2018-07-24', 'lastUpdatePostDateStruct': {'date': '2018-07-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '2-year progression free survival', 'timeFrame': '2 years after recruitment'}], 'secondaryOutcomes': [{'measure': 'complete remission', 'timeFrame': '4 months after treatment'}, {'measure': 'adverse events (AEs)', 'timeFrame': '2 years after recruitment'}, {'measure': '2-year overall survival', 'timeFrame': '2 years after recruitment'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Extranodal NK/T-cell Lymphoma']}, 'referencesModule': {'references': [{'pmid': '25980440', 'type': 'BACKGROUND', 'citation': 'Lee S, Park HY, Kang SY, Kim SJ, Hwang J, Lee S, Kwak SH, Park KS, Yoo HY, Kim WS, Kim JI, Ko YH. Genetic alterations of JAK/STAT cascade and histone modification in extranodal NK/T-cell lymphoma nasal type. Oncotarget. 2015 Jul 10;6(19):17764-76. doi: 10.18632/oncotarget.3776.'}]}, 'descriptionModule': {'briefSummary': 'This study is to explore the efficacy and safety of tofacitinib combined with chidamide in patients with relapsed and refractory extranodal NK/T cell lymphoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Patients with primary refractory or recurrent extranodal NK/T cell lymphoma that do not qualify for treatment protocols of higher priority.\n\n 2\\. Adequate renal function, as defined by estimated serum creatinine clearance \\>/=50 ml/min and/or serum creatinine \\</= 1.8 mg/dL.\n\n 3\\. 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\n 4.. Adequate cardiac function with left ventricular ejection fraction \\>/= 50%. No uncontrolled arrhythmias or symptomatic cardiac disease.\n\n 5\\. Performance status 0-1. 6. Negative Beta diffusing capacity of 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-1. Patients relapsed after allogeneic stem cell transplant 2. Patients with active hepatitis B or C(HBV DNA \\>/=10,000 copies/mL). 3. Active infection requiring parenteral antibiotics 4. HIV infection, unless the patient is receiving effective antiretroviral therapy with undetectable viral load and normal cluster of differentiation 4 (CD4) counts 5. Evidence of either cirrhosis or stage 3-4 liver fibrosis in patients with chronic hepatitis C or positive hepatitis C serology.\n\n6\\. Patients with a cQT longer than 500 ms'}, 'identificationModule': {'nctId': 'NCT03598959', 'briefTitle': 'Tofacitinib Combined With Chidamide in R/R ENKTCL', 'organization': {'class': 'OTHER', 'fullName': 'Sichuan University'}, 'officialTitle': 'Phase I/II Study of Safety and Efficacy of Tofacitinib Combined With Chidamide in Patients With Relapsed and Refractory Extranodal Natural Killer/T Cell Lymphoma', 'orgStudyIdInfo': {'id': 'HXNKT 2.0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Treated with tofacitinib and chidamide for 4 cycles.', 'interventionNames': ['Drug: tofacitinib', 'Drug: chidamide']}], 'interventions': [{'name': 'tofacitinib', 'type': 'DRUG', 'description': 'orally 10 mg daily', 'armGroupLabels': ['Treatment']}, {'name': 'chidamide', 'type': 'DRUG', 'description': 'orally 20 mg twice weekly', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '610044', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'West China Hospital of Sichuan University', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}], 'centralContacts': [{'name': 'Jie Ji, MD', 'role': 'CONTACT', 'email': 'jieji@scu.edu.cn', 'phone': '86-28-85422373'}, {'name': 'Ting Niu, MD', 'role': 'CONTACT', 'email': 'tingniu@sina.com', 'phone': '86-28-85422373'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sichuan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Jie Ji', 'investigatorAffiliation': 'Sichuan University'}}}}