Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2025-12-30 @ 7:40 AM
Study NCT ID:
NCT02445404
Status:
UNKNOWN
Last Update Posted:
2020-10-22
First Post:
2015-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Compare Efficacy of CHOP Versus Fractionated ICED in Transplant-eligible Patients With Previously Untreated PTCL
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016411', 'term': 'Lymphoma, T-Cell, Peripheral'}], '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'}, {'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': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D014750', 'term': 'Vincristine'}, {'id': 'D011241', 'term': 'Prednisone'}, {'id': 'D007069', 'term': 'Ifosfamide'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D005047', 'term': 'Etoposide'}, {'id': 'D003907', 'term': 'Dexamethasone'}], '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': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010078', 'term': 'Oxazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'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': 'D005960', 'term': 'Glucosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 134}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-09-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-21', 'studyFirstSubmitDate': '2015-05-12', 'studyFirstSubmitQcDate': '2015-05-12', 'lastUpdatePostDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-05-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'progression free survival', 'timeFrame': '3 years', 'description': 'Time to disease progression is defined as the time from treatment start to the first recording of relapse or disease progression or death of any cause'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '3 years', 'description': 'Duration of survival is defined as the time from treatment start to death of any cause or the date of last follow-up. Subjects who are alive will be censored using the date at which they are last known to be alive'}, {'measure': 'overall response rate', 'timeFrame': '3 years', 'description': 'They should be classified as complete remission(CR),Partial remission(PR),Stable disease(SD), or progression disease(PD)according to the Revised Response Criteria for Malignant Lymphoma'}, {'measure': 'Response duration', 'timeFrame': '3 years'}, {'measure': 'Toxicity profiles', 'timeFrame': '3 years', 'description': 'Toxicity profiles as measured by Adverse Events and Laboratory results.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Peripheral T-cell Lymphoma']}, 'descriptionModule': {'briefSummary': 'This study is a Randomized Phase II Study to Compare Efficacy of CHOP versus Fractionated ICED in Transplant-eligible Patients with Previously Untreated Peripheral T-cell Lymphoma.', 'detailedDescription': 'It recommends that the CHOP regimen in the primary T-cell lymphoma therapies currently used but did not get satisfactory effect of therapy (progression-free survival 40%), primarily to consider the clinical trial at NCCN guideline.But why the CHOP regimen is widely used because physicians are accustomed to use. Fractionated ICED therapy is a therapy by adjusting the Original ICE regimen.This is how the capacity of Ifosfamide divided into three days. (Fractionated ifosfamide).Original ICE therapy has been widely used as a salvage therapy of patients with relapsed or refractory lymphoma for a long time, it has been recommended as part of primary therapy of T-cell lymphoma.But Fractionated ICED is added to dexamethasone therapy in order to improve the effectiveness as a primary therapy.The recurrent lymphoma in 75 patients with treatment after Fractionated ICE when the self-stem cell transplantation, showed a more than 40% progression-free survival.Thus treatment of Fractionated ICED targeting previously untreated patients, and if a combination of high-dose dexamethasone to expect to be able to induce a progression-free survival of 60% or more.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 19-65 years\n2. Informed consent\n3. Subject able to adhere to the study visit schedule and other protocol requirements.\n4. Histologically proven Peripheral T-cell Lymphoma,No prior chemotherapy for the treatment of Peripheral T-cell Lymphoma It includes the following subtypes.\n\n * PTCL, not otherwise specified\n * Angioimmunoblastic T-cell lymphoma\n * Anaplastic large cell lymphoma, ALK-negative type\n * Enteropathy-associated T-cell lymphoma\n * Hepato-splenic T-cell lymphoma\n * Subcutaneous panniculitis-like T-cell lymphoma\n * Primary cutaneous gamma-delta T-cell lymphoma\n * Primary cutaneous CD8+ aggressive epidermotropic lymphoma\n * Other non classifiable T-cell Lymphoma\n5. Performance status (ECOG) 0,1 or 2\n6. A negative pregnancy test prior to treatment must be available both for pre-menopausal women\n7. Female of childbearing potential (FCBP) must: contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) while on IP; and for 3 months following the last dose of IP.Male subjects must practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions, and for 3 months following IP discontinuation.\n8. life expectancy≥90day(3months)\n\nExclusion Criteria:\n\n1. Other serious medical illnesses or psychiatric disorders\n2. Any state that the confusion in the interpretation of test result.\n3. Other type lymphoma ex) B-cell lymphoma\n4. Other type T-cell lymphoma\n\n * Adult T-Cell Leukemia/Lymphoma\n * NK/T-cell Lymphoma, Nasal Type\n * ALK-Positive Anaplastic Large-Cell Lymphoma\n * Cutaneous Tcell lymphoma\n * primary cutaneous CD30+ lympho- proliferative disorder\n * primary cutaneous Anaplastic T cell lymphoma\n5. Previously treated for PTCL(Except for a short period before randomization of corticosteroids (a period of not more than 8 days)\n6. Previous radiation therapy\n7. CNS involvement.\n8. If the contraindication to chemoherapy\n9. Subject has known historical or active infection with HIV.\n10. BM function: ANC \\< 1.5 × 109/L; Platelet count \\<100,000/mm2 (100 × 109/L), SGOT/AST or SGPT/ALT ≥ 3.0 x ULN, Bilirubin\\> 2 x upper normal value\n11. serum creatinine level \\> 2.0 x ULN\n12. Any other malignancies within the past 3 years except curatively treated non-melanoma skin cancer or in situ carcinoma of cervix uteri\n13. MUGA scan \\<45%\n14. Those who administered doxorubicin exceeding 200 mg / m2\n15. Subject has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.\n16. Breast-feeding or pregnant female'}, 'identificationModule': {'nctId': 'NCT02445404', 'briefTitle': 'Compare Efficacy of CHOP Versus Fractionated ICED in Transplant-eligible Patients With Previously Untreated PTCL', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Randomized Phase II Study to Compare Efficacy of CHOP Versus Fractionated ICED in Transplant-eligible Patients With Previously Untreated Peripheral T-cell Lymphoma', 'orgStudyIdInfo': {'id': '2014-12-011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CHOP', 'description': 'cyclophosphamide, 750mg/m² IV day1 doxorubicin, 50 mg/m² IV day1 vincristine, 1.4 mg/m² (max 2 mg) IV day1 prednisone ,40 mg/m² PO day1\\~5 every 3 weeks', 'interventionNames': ['Drug: CHOP', 'Drug: fractionated ICED']}, {'type': 'EXPERIMENTAL', 'label': 'Fractionated ICED', 'description': 'ifosfamide, 1.67 g/m² IV day1\\~3 carboplatin, AUC =5 IV day1 etoposide, 100mg/m² IV day1\\~3 dexamethasone 40 mg PO or IV day1\\~4 every 3 weeks', 'interventionNames': ['Drug: CHOP', 'Drug: fractionated ICED']}], 'interventions': [{'name': 'CHOP', 'type': 'DRUG', 'otherNames': ['cyclophosphamide, cyclophosphamide, vincristine,prednisone'], 'description': 'cyclophosphamide, 750mg/m² IV day1 doxorubicin, 50 mg/m² IV day1 vincristine, 1.4 mg/m² (max 2 mg) IV day1 prednisone ,40 mg/m² PO day1\\~5 every 3 weeks', 'armGroupLabels': ['CHOP', 'Fractionated ICED']}, {'name': 'fractionated ICED', 'type': 'DRUG', 'otherNames': ['ifosfamide, carboplatin, etoposide, dexamethasone'], 'description': 'ifosfamide, 1.67 g/m² IV day1\\~3 carboplatin, AUC =5 IV day1 etoposide, 100mg/m² IV day1\\~3 dexamethasone 40 mg PO or IV day1\\~4 every 3 weeks', 'armGroupLabels': ['CHOP', 'Fractionated ICED']}]}, 'contactsLocationsModule': {'locations': [{'zip': '135-710', 'city': 'Seoul', 'state': 'Seoul, Korea, Republic of', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Won Seog Kim, M.D, Ph. D', 'role': 'CONTACT', 'email': 'wskimsmc@skku.edu', 'phone': '234106548', 'phoneExt': '82'}, {'name': 'Seok Jin Kim, M.D,Ph. D', 'role': 'CONTACT', 'email': 'kstwoh@skku.edu', 'phone': '234101766', 'phoneExt': '82'}], 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Won Seog Kim, MD,Ph.D.', 'role': 'CONTACT', 'email': 'wskimsmc@skku.edu', 'phone': '234106548', 'phoneExt': '82'}], 'overallOfficials': [{'name': 'Won Seog Kim, MD,Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center,Seoul,Korea'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Won Seog Kim', 'investigatorAffiliation': 'Samsung Medical Center'}}}}