Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-25 @ 9:27 PM
Study NCT ID:
NCT01300156
Status:
UNKNOWN
Last Update Posted:
2011-02-21
First Post:
2011-02-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Etoposide, Methylprednisolone, High-dose Cytarabine and Oxaliplatin (ESHAOx) for Refractory or Relapsed Hodgkin's Lymphoma (HL)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006689', 'term': 'Hodgkin Disease'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D012008', 'term': 'Recurrence'}], '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'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 37}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-02', 'completionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-02-18', 'studyFirstSubmitDate': '2011-02-18', 'studyFirstSubmitQcDate': '2011-02-18', 'lastUpdatePostDateStruct': {'date': '2011-02-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Response rate to ESHAOx chemotherapy', 'timeFrame': 'within 3 weeks after the completion of the treatment', 'description': "To evaluate response rate by Cheson criteria for malignant lymphoma after 3 and 6 cycles of treatment with ESHAOx regimen in patients with refractory or relapsed Hodgkin's lymphoma."}], 'secondaryOutcomes': [{'measure': 'Overall survival, response duration, toxicity profiles', 'timeFrame': 'up to 5 years after the completion of treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ["Hodgkin's disease", 'lymphoma', 'Relapsed', 'refractory'], 'conditions': ["Hodgkin's Lymphoma"]}, 'referencesModule': {'references': [{'pmid': '31897676', 'type': 'DERIVED', 'citation': "Won YW, Lee H, Eom HS, Kim JS, Suh C, Yoon DH, Hong JY, Kang HJ, Lee JH, Kim WS, Kim SJ, Lee WS, Chang MH, Do YR, Yi JH, Kim I, Won JH, Kim K, Oh SY, Jo JC. A phase II study of etoposide, methylprednisolone, high-dose cytarabine, and oxaliplatin (ESHAOx) for patients with refractory or relapsed Hodgkin's lymphoma. Ann Hematol. 2020 Feb;99(2):255-264. doi: 10.1007/s00277-019-03891-9. Epub 2020 Jan 2."}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to evaluate the efficacy and safety of combination chemotherapy with etoposide, methylprednisolone, high-dose cytarabine and oxaliplatin (ESHAOx) for patients with refractory or relapsed Hodgkin's lymphoma (HL)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Previously histologically confirmed Hodgkin's lymphoma\n* Failure to achieve a complete remission with the initial induction chemotherapy, or recurrent disease\n* Performance status (ECOG) ≤ 3\n* Age ≤ 75 years old\n* Number of prior chemotherapies: one or two regimens\n* At least one or more uni-dimensionally measurable lesion(s) defined as; ≥ 2 cm by conventional CT or ≥ 1 cm by spiral CT or skin lesion (photographs should be taken) or measurable lesion by physical examination\n* Adequate organ functions defined as; ANC \\> 1,500/ul, platelet \\> 75,000/ul, transaminases \\< 3 X upper normal values; bilirubin \\< 2 mg/dL\n* Written informed consent approved by institutional review board or ethic committee\n\nExclusion Criteria:\n\n* Previous high dose chemotherapy with autologous stem cell transplantation or allogeneic stem cell transplantation\n* Previous chemotherapies with ESHAP regimen\n* Any other malignancies within the past 5 years except skin basal cell carcinoma or carcinoma in situ of cervix\n* Other serious illness or medical conditions\n* Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry\n* History of significant neurologic or psychiatric disorders including dementia or seizures\n* Active uncontrolled infection (viral, bacterial or fungal infection)\n* Other serious medical illnesses\n* Pregnancy or breast-feeding, women of childbearing potential not employing adequate contraception\n* Previous history of drug allergy to one of the drugs in the study regimen"}, 'identificationModule': {'nctId': 'NCT01300156', 'briefTitle': "Etoposide, Methylprednisolone, High-dose Cytarabine and Oxaliplatin (ESHAOx) for Refractory or Relapsed Hodgkin's Lymphoma (HL)", 'organization': {'class': 'OTHER_GOV', 'fullName': 'National Cancer Center, Korea'}, 'officialTitle': "A Multicenter Phase II Study of Etoposide, Methylprednisolone, High-dose Cytarabine and Oxaliplatin (ESHAOx) for Patients With Refractory or Relapsed Hodgkin's Lymphoma (HL)", 'orgStudyIdInfo': {'id': 'NCCCTS-10-524'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ESHAOx arm', 'description': 'Patients who are planned to be treated with ESHAOx chemotherapy', 'interventionNames': ['Drug: Oxaliplatin-based chemotherapy (ESHAOx)']}], 'interventions': [{'name': 'Oxaliplatin-based chemotherapy (ESHAOx)', 'type': 'DRUG', 'description': '* Etoposide 40 mg/m2, D1-4\n* Methylprednisolone 500mg, D1-5\n* Cytarabine 2 g/m2, D5\n* Oxaliplatin 130 mg/m2, D1', 'armGroupLabels': ['ESHAOx arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Goyang', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Hyewon Lee, MD', 'role': 'CONTACT', 'email': 'hwlee@ncc.re.kr', 'phone': '+82-31-920-1765'}, {'name': 'Hyeon Seok Eom, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'National Cancer Center, Korea', 'geoPoint': {'lat': 36.21689, 'lon': 127.19731}}], 'centralContacts': [{'name': 'Hyewon Lee, MD', 'role': 'CONTACT', 'email': 'hwlee@ncc.re.kr', 'phone': '+82-31-920-1765'}], 'overallOfficials': [{'name': 'Hyeon Seok Eom, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cancer Center, Korea'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Center, Korea', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Asan Medical Center', 'class': 'OTHER'}, {'name': 'Severance Hospital', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Hyeon-Seok Eom / MD, PhD', 'oldOrganization': 'Natioinal Cancer Center, Korea'}}}}