Ignite Creation Date:
2025-12-24 @ 11:48 PM
Ignite Modification Date:
2026-02-22 @ 9:37 AM
Study NCT ID:
NCT04511351
Status:
UNKNOWN
Last Update Posted:
2020-08-13
First Post:
2020-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radiotherapy Combined With GDP With or Without Chidamide in Stage I/II Extranodal Nasal NK/T-cell Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 76}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-08-12', 'studyFirstSubmitDate': '2020-08-10', 'studyFirstSubmitQcDate': '2020-08-12', 'lastUpdatePostDateStruct': {'date': '2020-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': '2 years', 'description': 'Defined as the time from the date of study treatment until the earliest date of disease progression, as determined by radiographic disease assessment provided by an IRC, or death from any cause.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': '2 years', 'description': 'Defined as the time from the date of study treatment until death from any cause'}, {'measure': 'Treatment response', 'timeFrame': '2 years', 'description': 'Defined as the percentage of participants with a CR or PR as defined by revised response criteria for lymphoma (Cheson et al 2014)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lymphoma']}, 'descriptionModule': {'briefSummary': 'Currently, combined chemotherapy (CT) and radiation (RT) is recognized as the standard treatment for high-risk early-stage NKTCL. However, treatment failure occured in nearly 30% of patients receiving CRT and systemic failure are the most common failure form. Chidamide is a HADC inhibitor, which presents satisfactory efficacy in NKTCL especially in terms of improving durable remission time. In our previous study, IMRT followed by GDP was demonstrated effective in early-stage NKTCL. Therefore, we designed a prospective phase II clinical trial of IMRT followed by GDP with or without chidamide in patients with high-risk early-stage NKTCL.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosis of NKTCL with typical morphology and immunophenotype, according to the 2008 World Health Organization classification of lymphomas;\n2. no prior radiotherapy or chemotherapy;\n3. age ≥ 18 years;\n4. ECOG performance status 0-2;\n5. Ann Arbor stages I and II;\n6. tumors primarily occurring in the upper aerodigestive tract;\n7. at least one unfavorable prognostic factor (age \\> 60 years, B symptoms, elevated LDH, ECOG score 2, regional node involvement, and PTI);\n8. at least one measurable lesion;\n9. adequate hematological, hepatic, and renal functions; e.g., absolute neutrophil count ≥ 1.5 × 109/L, platelet count ≥ 80 × 109/L, total bilirubin ≤ 1.5 × upper limit of normal, alanine transaminase and aspartate transaminase ≤ 2 × upper limit of normal, and creatinine ≤ 1.5 mg/dl;\n10. life expectancy of more than 3 months.\n\nExclusion Criteria:\n\n1. Patients with advanced stage disease;\n2. pregnancy or lactation;\n3. any coexisting medical problems of sufficient severity to prevent full compliance with the study protocol.'}, 'identificationModule': {'nctId': 'NCT04511351', 'briefTitle': 'Radiotherapy Combined With GDP With or Without Chidamide in Stage I/II Extranodal Nasal NK/T-cell Lymphoma', 'organization': {'class': 'UNKNOWN', 'fullName': 'ChineseAMS'}, 'officialTitle': 'Radiotherapy Combined With GDP (Gemcitabine, Cisplatin, Dexamethasone) Chemotherapy With or Without Chidamide in High-risk Early-stage Extranodal Nasal NK/T-cell Lymphoma', 'orgStudyIdInfo': {'id': 'CAMS lymphoma'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RT+GDP+Chidamide', 'description': 'IMRT followed by GDP chemotherapy with chidamide during radiation and chemotherapy phase', 'interventionNames': ['Drug: Chidamide']}, {'type': 'NO_INTERVENTION', 'label': 'RT+GDP', 'description': 'IMRT followed by GDP chemotherapy without chidamide during radiation and chemotherapy phase'}], 'interventions': [{'name': 'Chidamide', 'type': 'DRUG', 'description': 'chidamide administration during radiation and chemotherapy phase in the study group', 'armGroupLabels': ['RT+GDP+Chidamide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100021', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Mei Dong', 'role': 'CONTACT', 'email': 'dongmei030224@163.com', 'phone': '13811929322'}], 'facility': 'National Cancer Center, Cancer Hospital, Chinese Academy of Medical Scienses', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Mei Dong', 'role': 'CONTACT', 'email': 'dongmei030224@163.com', 'phone': '010-87787447'}], 'overallOfficials': [{'name': 'Mei Dong', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cancer Hospital, Chinese Academy of Medical Scienses'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese Academy of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director Physician', 'investigatorFullName': 'Mei Dong', 'investigatorAffiliation': 'Chinese Academy of Medical Sciences'}}}}