Ignite Creation Date:
2025-12-24 @ 3:18 PM
Ignite Modification Date:
2026-01-31 @ 8:22 AM
Study NCT ID:
NCT01746992
Status:
UNKNOWN
Last Update Posted:
2017-11-14
First Post:
2012-12-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CTOP/ITE/MTX Compared With CHOP as the First-line Therapy for Newly Diagnosed Young Patients With T Cell Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007119', 'term': 'Immunoblastic Lymphadenopathy'}, {'id': 'D058527', 'term': 'Enteropathy-Associated T-Cell Lymphoma'}, {'id': 'C537503', 'term': 'Subcutaneous panniculitis-like T-cell lymphoma'}], 'ancestors': [{'id': 'D000072281', 'term': 'Lymphadenopathy'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'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': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D014750', 'term': 'Vincristine'}, {'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D011241', 'term': 'Prednisone'}, {'id': 'C036266', 'term': 'prednylidene'}, {'id': 'D007069', 'term': 'Ifosfamide'}, {'id': 'C027260', 'term': 'pirarubicin'}, {'id': 'C061400', 'term': 'etoposide phosphate'}, {'id': 'D005047', 'term': 'Etoposide'}, {'id': 'D008727', 'term': 'Methotrexate'}], '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': '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': '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': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D010078', 'term': 'Oxazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D011034', 'term': 'Podophyllotoxin'}, {'id': 'D013764', 'term': 'Tetrahydronaphthalenes'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-11-10', 'studyFirstSubmitDate': '2012-12-04', 'studyFirstSubmitQcDate': '2012-12-09', 'lastUpdatePostDateStruct': {'date': '2017-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'complete remission rate', 'timeFrame': '6 months'}, {'measure': '3-year PFS', 'timeFrame': '3 years'}], 'secondaryOutcomes': [{'measure': 'overall response rate', 'timeFrame': '6 months'}, {'measure': '3-year os', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['ALK-negative Anaplastic Large Cell Lymphoma', 'Peripherial T Cell Lymphoma,Not Otherwise Specified', 'Angioimmunoblastic T Cell Lymphoma', 'Enteropathy Associated T Cell Lymphoma', 'Hepatosplenic T Cell Lymphoma', 'Subcutaneous Panniculitis Like T Cell Lymphoma']}, 'descriptionModule': {'briefSummary': "T cell lymphoma is a heterogenic malignancy with poor outcome. Five-year PFS and OS of the patients recieved classic CHOP regimen(cyclophosphamide,vincristin,doxorubicin and predisone)is less than 30%.High dose intensive chemotherapy doesn't demonstrate better response. At present, there is no standardized treatment protocol for this kind of lymphoma.\n\nBetween 1994 and 1998,the Scotland and Newcastle Lymphoma Group prospectively collected data on newly diagnosed patients with enteropathy associated T-cell lymphoma (EATL)in the Northern Region of England and Scotland,which is a rare and aggressive type of peripheral T-cell lymphoma.The novel regimen IVE/MTX (ifosfamide, vincristine, etoposide/methotrexate)-ASCT was piloted for patients eligible for intensive treatment,followed by auto-stem cell transplantation.Five-years PFS and OS were 52% and 60% respectively, significantly improved compared with the historical group treated with anthracycline-based chemotherapy. The encouraged results were extended to the peripherial T cell lymphoma-non specified(PTCL-nos).\n\nPast studies suggested pirarubicin was more active to the T cell lymphoma than doxorubicin in vitro based on its high concentration in tumor cells. Clinical data also presented equivalent even superior efficacy of pirarubicin with lower toxicity than doxorubicin. The aim of our study is to compare the response and survival rate of CTOP/ITE/MTX (cyclophosphamide, vincristin,pirarubicin and predisone/ ifosfamide, pirarubicin, etoposide/methotrexate) with those of CHOP regimen,looking forward to its superiority in efficacy and safety for the de novo young patients with T cell lymphoma."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pathologic verified mature T cell lymphoma,including ALK-negative anaplastic large cell lymphoma,peripherial T cell lymphoma-non specific type,angioimmunoblastic T cell lymphoma,enteropathy associated T cell lymphoma and hepatosplenic T cell lymphoma\n* SGOT/SGPT no more than 2 times of UNL\n* serum creatinine no more than 1.5 times of UNL\n* signed informed consent\n\nExclusion Criteria:\n\n* woman in pregnancy or lactation\n* allergic to any intervention drug\n* insuitable to the study due to severe complication\n* enrolled to other study during the past 6 months'}, 'identificationModule': {'nctId': 'NCT01746992', 'briefTitle': 'CTOP/ITE/MTX Compared With CHOP as the First-line Therapy for Newly Diagnosed Young Patients With T Cell Lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'Ruijin Hospital'}, 'officialTitle': 'An Open-label,Multicenter Randomised Study of CTOP/ITE/MTX Compared With CHOP as the First-line Therapy for the New Diagnosed Young Patients With T Cell Non-hodgkin Lymphoma', 'orgStudyIdInfo': {'id': 'CTOP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'pirarubicin', 'description': '3 cycles of CTOP(cyclophosphamide,vincristin,pirarubicin and prednisone),3 cycles of ITE(ifosfamide, pirarubicin, etoposide)and 2 cycles of methotrexate', 'interventionNames': ['Drug: Cyclophosphamide 750mg/m2', 'Drug: Vincristine 1.4mg/m2', 'Drug: prednisone 60mg/m2', 'Drug: ifosfamide 2000mg/m2', 'Drug: pirarubicin 50mg/m2', 'Drug: pirarubicin 25mg/m2', 'Drug: Etoposide phosphate 100mg/m2', 'Drug: methotrexate 1500mg/m2']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'doxorubicin', 'description': '8 cycles of CHOP regimen(cyclophosphamide,vincristin,doxorubicin and prednisone)', 'interventionNames': ['Drug: Cyclophosphamide 750mg/m2', 'Drug: Vincristine 1.4mg/m2', 'Drug: Doxorubicin 50mg/m2', 'Drug: prednisone 60mg/m2']}], 'interventions': [{'name': 'Cyclophosphamide 750mg/m2', 'type': 'DRUG', 'otherNames': ['CTX'], 'description': 'day 1 in both arms', 'armGroupLabels': ['doxorubicin', 'pirarubicin']}, {'name': 'Vincristine 1.4mg/m2', 'type': 'DRUG', 'otherNames': ['VCR'], 'description': 'day 1', 'armGroupLabels': ['doxorubicin', 'pirarubicin']}, {'name': 'Doxorubicin 50mg/m2', 'type': 'DRUG', 'otherNames': ['ADM'], 'description': 'day 1', 'armGroupLabels': ['doxorubicin']}, {'name': 'prednisone 60mg/m2', 'type': 'DRUG', 'otherNames': ['PRED'], 'description': 'day1-day5', 'armGroupLabels': ['doxorubicin', 'pirarubicin']}, {'name': 'ifosfamide 2000mg/m2', 'type': 'DRUG', 'otherNames': ['IFO'], 'description': 'day 22-day 24', 'armGroupLabels': ['pirarubicin']}, {'name': 'pirarubicin 50mg/m2', 'type': 'DRUG', 'otherNames': ['THP'], 'description': 'day 1', 'armGroupLabels': ['pirarubicin']}, {'name': 'pirarubicin 25mg/m2', 'type': 'DRUG', 'otherNames': ['THP'], 'description': 'day 22', 'armGroupLabels': ['pirarubicin']}, {'name': 'Etoposide phosphate 100mg/m2', 'type': 'DRUG', 'otherNames': ['VP-16'], 'description': 'day 22-day 24', 'armGroupLabels': ['pirarubicin']}, {'name': 'methotrexate 1500mg/m2', 'type': 'DRUG', 'otherNames': ['MTX'], 'description': 'day 43', 'armGroupLabels': ['pirarubicin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200025', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Ruijin hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ruijin Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'vice director of Department of Hematology', 'investigatorFullName': 'Zhao Weili', 'investigatorAffiliation': 'Ruijin Hospital'}}}}