Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2026-01-07 @ 9:12 PM
Study NCT ID:
NCT03617432
Status:
UNKNOWN
Last Update Posted:
2018-09-04
First Post:
2018-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chidamide Combined With CHOPE Regimen for Peripheral T-cell Lymphoma Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009374', 'term': 'Neoplasms, Experimental'}], 'ancestors': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C547816', 'term': 'N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D014750', 'term': 'Vincristine'}, {'id': 'D005047', 'term': 'Etoposide'}, {'id': 'D011241', 'term': 'Prednisone'}], 'ancestors': [{'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}, {'id': 'D011034', 'term': 'Podophyllotoxin'}, {'id': 'D013764', 'term': 'Tetrahydronaphthalenes'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 114}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-08-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2022-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-08-30', 'studyFirstSubmitDate': '2018-08-01', 'studyFirstSubmitQcDate': '2018-08-01', 'lastUpdatePostDateStruct': {'date': '2018-09-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'complete remission (CR）rate', 'timeFrame': 'up to 2 years', 'description': 'The rate of patients who achieve complete remission after the treatment.'}], 'secondaryOutcomes': [{'measure': 'objective response rate（ORR）', 'timeFrame': 'up to 2 years', 'description': 'The total proportion of patients with complete response（CR）and partial response（PR）.'}, {'measure': 'progression-free survival（PFS）', 'timeFrame': '2 years', 'description': 'Time from treatment until disease progression or death.'}, {'measure': 'overall survival（OS）', 'timeFrame': "2 years after the last patient's enrollment.", 'description': 'From the date of inclusion to date of death, irrespective of any cause.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Experimental Tumor']}, 'descriptionModule': {'briefSummary': 'Chidamide With Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Etoposide for Peripheral T Cell Lymphoma Patients : a Prospective, Randomized Controlled, Open Label, Phase II Clinical Trial', 'detailedDescription': 'Chidamide，a novel histone deacetylase inhibitor has been approved for the treatment of relapsed or refractory peripheral T-cell lymphoma in China. The aim of this study was to observe the efficacy and safety of Chidamide With Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Etoposide for Peripheral T Cell Lymphoma Patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Histopathology / cytology diagnosed as peripheral T cell lymphoma (PTCL) according to WHO 2016 classification criteria（NK/T cell lymphoma and ALK positive anaplastic large cell lymphoma excluded）including:Peripheral T-cell lymphoma, NOS，Angioimmunoblastic T-cell lymphoma，Anaplastic large-cell lymphoma, ALK negative，Enteropathy-associated T-cell lymphoma，Hepatosplenic T-cell lymphoma，Subcutaneous panniculitis T-cell lymphoma，Mycosis fungoides，Other T-cell lymphoma that investigators consider to be appropriate to be enrolled;\n2. Patients have received CHOPE regimen for 2 cycles therapy and achieve PR or SD;\n3. Patients should have at least one evaluable foci ( lymph nodes with diameter≥1.5cm, or evaluable skin foci);\n4. Age 18-70 years, male or female;\n5. ECOG performance status 0-2;\n6. Absolute neutrophil count ≥1.5×109/L, platelet ≥75×109/L, Hb ≥ 90g/L;\n7. ALT and serum creatinine \\<1.5 times of normal maximum;\n8. Life expectancy no less than 3 months;\n9. Willing to sign the Informed Consent Form.\n\nExclusion Criteria:\n\n1. NK/T cell lymphoma or ALK positive anaplastic large cell lymphoma;\n2. Female patients in lactation or pregnancy, Childbearing female or male patients unwilling to take contraceptive measures;\n3. QTc elongation with clinical significance ( male\\> 450ms, female\\> 470ms), ventricular tachycardia, atrial fibrillation, cardiac conducting blockage, myocardial infarction within 1 year, congestive heart failure, symptomatic coronary heart disease that requires treatment;\n4. Patients have undergone organ transplantation;\n5. Patients received symptomatic treatment for bone marrow toxicity within 7 days prior to enrollment;\n6. Patients with active hemorrhage;\n7. Patients with or with history of thrombosis, embolism, cerebral hemorrhage, or cerebral infarction;\n8. Patients with active infection or continuous fever within 14 days prior to enrollment;\n9. Had major organ surgery within 6 weeks prior to enrollment;\n10. Impaired liver function ( Total bilirubin \\> 1.5 times of normal maximum, ALT/AST\\> 2.5 times of normal maximum, for patients with infiltrative liver disease ALT/AST\\> 5 times of normal maximum), impaired renal function (serum creatinine\\> 1.5 times of normal maximum);\n11. Patients with mental disorders or those do not have the ability to consent;\n12. Patients with drug abuse, long term alcoholism that may impact the results of the trial;\n13. Patients with invasion of central nervous system ;\n14. Non-appropriate patients for the trial according to the judgment of the investigators.'}, 'identificationModule': {'nctId': 'NCT03617432', 'briefTitle': 'Chidamide Combined With CHOPE Regimen for Peripheral T-cell Lymphoma Patients', 'organization': {'class': 'OTHER', 'fullName': 'Peking University'}, 'officialTitle': 'Chidamide With Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Etoposide for Peripheral T Cell Lymphoma Patients : a Prospective, Randomized Controlled, Open Label, Phase II Clinical Trial', 'orgStudyIdInfo': {'id': 'CSIIT-T13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'Experimental group will be treated by Chidamide combined CHOPE (Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Etoposide ) regimen for 6 cycles.', 'interventionNames': ['Drug: Chidamide', 'Drug: Cyclophosphamide', 'Drug: Doxorubicin', 'Drug: Vincristine', 'Drug: Etoposide', 'Drug: Prednisone']}, {'type': 'EXPERIMENTAL', 'label': 'Control group', 'description': 'Control group will be treated by CHOPE (Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Etoposide ) regimen for 6 cycles.', 'interventionNames': ['Drug: Cyclophosphamide', 'Drug: Doxorubicin', 'Drug: Vincristine', 'Drug: Etoposide', 'Drug: Prednisone']}], 'interventions': [{'name': 'Chidamide', 'type': 'DRUG', 'otherNames': ['epidaza'], 'description': 'Chidamide 15mg orally BIW. Six cycles of therapy will be administered, and each cycle of treatment is 21 days.', 'armGroupLabels': ['Experimental group']}, {'name': 'Cyclophosphamide', 'type': 'DRUG', 'description': 'Cyclophosphamide(750mg/m2) was administered intravenously on d1. Six cycles of therapy will be administered, and each cycle of treatment is 21 days.', 'armGroupLabels': ['Control group', 'Experimental group']}, {'name': 'Doxorubicin', 'type': 'DRUG', 'description': 'Doxorubicin (50mg/m2)was administered intravenously on d1.Six cycles of therapy will be administered, and each cycle of treatment is 21 days.', 'armGroupLabels': ['Control group', 'Experimental group']}, {'name': 'Vincristine', 'type': 'DRUG', 'description': 'Vincristine (1.4mg)was administered intravenously on d1.Six cycles of therapy will be administered, and each cycle of treatment is 21 days.', 'armGroupLabels': ['Control group', 'Experimental group']}, {'name': 'Etoposide', 'type': 'DRUG', 'description': 'Etoposide (100mg/m2) was administered intravenously on d1,2,3.Six cycles of therapy will be administered, and each cycle of treatment is 21 days.', 'armGroupLabels': ['Control group', 'Experimental group']}, {'name': 'Prednisone', 'type': 'DRUG', 'description': 'Prednisone (100mg)was administered by oral on d1-5.Six cycles of therapy will be administered, and each cycle of treatment is 21 days.', 'armGroupLabels': ['Control group', 'Experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100142', 'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jun Zhu, MD', 'role': 'CONTACT', 'email': 'zj@bjcancer.org', 'phone': '+86-10-88196596'}, {'name': 'Weiping Liu, MD', 'role': 'CONTACT', 'email': 'dreaming2217@126.com', 'phone': '+86-10-88196109'}, {'name': 'Jun Zhu, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Beijing Cancer Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Jun Zhu, Dr.', 'role': 'CONTACT', 'email': 'dreaming2217@hotmai.com', 'phone': '010-88140650'}, {'name': 'Yuqin Song, Dr.', 'role': 'CONTACT', 'email': 'songyuqin622@163.com', 'phone': '010-88140650'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Peking University International Hospital', 'class': 'OTHER'}, {'name': 'Shandong Tumor Hospital', 'class': 'OTHER'}, {'name': 'Jiangxi Provincial Cancer Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of lymphoma department', 'investigatorFullName': 'Jun Zhu', 'investigatorAffiliation': 'Peking University'}}}}