Ignite Creation Date:
2025-12-24 @ 5:21 PM
Ignite Modification Date:
2026-01-01 @ 7:26 PM
Study NCT ID:
NCT04917250
Status:
UNKNOWN
Last Update Posted:
2021-06-08
First Post:
2021-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
GPED for Patients With Relapsed/Refractory or Advanced NK/T-cell Lymphoma
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': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'C042705', 'term': 'pegaspargase'}, {'id': 'D005047', 'term': 'Etoposide'}, {'id': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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': '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': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-02', 'studyFirstSubmitDate': '2021-06-02', 'studyFirstSubmitQcDate': '2021-06-02', 'lastUpdatePostDateStruct': {'date': '2021-06-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'overall response rate', 'timeFrame': '24 weeks ±7 days', 'description': 'evaluated by PET-CT and MRI, according to Lugano 2014 criteria'}], 'secondaryOutcomes': [{'measure': 'complete response rate', 'timeFrame': '24 weeks ±7 days', 'description': 'evaluated by PET-CT and MRI, according to Lugano 2014 criteria'}, {'measure': '1-year progression free survival rate', 'timeFrame': 'up to 1year after enrollment', 'description': 'time from date of enrollment to date of disease progression, death of any reason, whichever comes first'}, {'measure': '1-year overall survival rate', 'timeFrame': 'up to 1year after enrollment', 'description': 'time from date of enrollment to date death of any reason'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Extranodal NK/T-cell Lymphoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of GPED (gemcitabine, pegaspargase, etoposide, and dexamethasone) regimen in the treatment of Relapsed/Refractory or advanced NK/T-cell lymphoma patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nHistopathology and immunohistochemistry confirmed diagnosis of NK/Tcell lymphoma according to WHO 2016 criteria.\n\n* refractory or relapsed after initial remission, or stage III-IV de novo patients\n* PET/CT or CT/MRI with at least one objectively evaluable lesion.\n* General status ECOG score 0-3 points.\n* The laboratory test within 1 week before enrollment meets the following conditions: Blood routine: Hb\\>80g/L, PLT\\>50×10e9/L. Liver function: ALT, AST, TBIL ≤2 times the upper limit of normal. Renal function: Cr is normal. Cardiac function: LVEF≥50%, ECG does not suggest any acute myocardial infarction, arrhythmia or atrioventricular conduction above I Blocking.\n* Sign the informed consent form\n\nExclusion Criteria:\n\nActive infection requires ICU treatment. Concomitant HIV infection or active infection with HBV, HCV. Patients who are infected with HBV but not active hepatitis at the same time are notexcluded.\n\nSignificant organ dysfunction Pregnant and lactating women. Had a history of autoimmune diseases, and disease was active in the last 6 months.\n\nThose who were known to be allergic to drugs in the study regimen. Patients with other tumors who require surgery or chemotherapy within 6 months.\n\n• Other experimental drugs are being used.'}, 'identificationModule': {'nctId': 'NCT04917250', 'briefTitle': 'GPED for Patients With Relapsed/Refractory or Advanced NK/T-cell Lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Tongren Hospital'}, 'officialTitle': 'Gemcitabine, Pegaspargase, Etoposide, and Dexamethasone (GPED) for Patients With Relapsed/Refractory or Advanced NK/T-cell Lymphoma : a Single Arm,Open-lable,Phase II Study', 'orgStudyIdInfo': {'id': 'TRhos-ENKTCL-7'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'treatment arm', 'description': 'Treated with gemcitabine, pegaspargase, etoposide and dexamethasone', 'interventionNames': ['Drug: Gemcitabine', 'Drug: Pegaspargase', 'Drug: Etoposide', 'Drug: Dexamethasone']}], 'interventions': [{'name': 'Gemcitabine', 'type': 'DRUG', 'description': '1000mg/㎡，d1,4 ivdrip', 'armGroupLabels': ['treatment arm']}, {'name': 'Pegaspargase', 'type': 'DRUG', 'description': '2500IU/㎡, maximum dose less than 3750IU', 'armGroupLabels': ['treatment arm']}, {'name': 'Etoposide', 'type': 'DRUG', 'description': '100mg/㎡，d1-3 ivdrip', 'armGroupLabels': ['treatment arm']}, {'name': 'Dexamethasone', 'type': 'DRUG', 'description': '20mg/d d1-4 ivdrip', 'armGroupLabels': ['treatment arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100730', 'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Liang Wang, M.D.', 'role': 'CONTACT', 'email': 'wangliangtrhos@126.com', 'phone': '+861058268442'}], 'facility': 'Beijing Tongren Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Liang Wang, M.D.', 'role': 'CONTACT', 'email': 'wangliangtrhos@126.com', 'phone': '+861058268442'}], 'overallOfficials': [{'name': 'Liang Wang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Tongren Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Tongren Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Dept. of Hematology, Beijing Tongren Hospital', 'investigatorFullName': 'LIANG WANG', 'investigatorAffiliation': 'Beijing Tongren Hospital'}}}}