Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2026-02-24 @ 5:08 AM
Study NCT ID:
NCT03794167
Status:
COMPLETED
Last Update Posted:
2019-01-07
First Post:
2019-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BuCE Versus BuME as Conditioning Therapy in Non-Hodgkin's Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}], 'ancestors': [{'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': 'D002066', 'term': 'Busulfan'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D005047', 'term': 'Etoposide'}, {'id': 'D008558', 'term': 'Melphalan'}], 'ancestors': [{'id': 'D002072', 'term': 'Butylene Glycols'}, {'id': 'D006018', 'term': 'Glycols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D008698', 'term': 'Mesylates'}, {'id': 'D000476', 'term': 'Alkanesulfonates'}, {'id': 'D017738', 'term': 'Alkanesulfonic Acids'}, {'id': 'D000473', 'term': 'Alkanes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013451', 'term': 'Sulfonic Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'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': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D010649', 'term': 'Phenylalanine'}, {'id': 'D024322', 'term': 'Amino Acids, Aromatic'}, {'id': 'D000598', 'term': 'Amino Acids, Cyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel assignment'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-03', 'studyFirstSubmitDate': '2019-01-03', 'studyFirstSubmitQcDate': '2019-01-03', 'lastUpdatePostDateStruct': {'date': '2019-01-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of progression free survival', 'timeFrame': '2 years', 'description': 'calculate from the date of ASCT until the time of disease progression, relapse, or death calculate from the date of ASCT until the time of disease progression, relapse, or death calculate from the date of ASCT until the time of disease progression, relapse, or death Calculate from the date of ASCT (autologous stem cell transplantation) until the time of disease progression, relapse, or death'}], 'secondaryOutcomes': [{'measure': 'Rate of overall survival', 'timeFrame': '2 years', 'description': 'calculate from the date of ASCT until the time of death from any causes'}, {'measure': 'Rate of regimen related toxicity', 'timeFrame': '6 months', 'description': 'calculate toxicities frequency'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non-hodgkin Lymphoma']}, 'descriptionModule': {'briefSummary': "The investigators developed a protocol comparing busulfan/cyclophosphamide/etoposide (BuCE) and busulfan/melphalan/etoposide (BuME) regimen as a conditioning for high-dose therapy (HDT) in the patients with high risk or relapsed Non-Hodgkin's Lymphoma (NHL).", 'detailedDescription': 'Intravenous busulfan containing regimens as conditioning regimen have been used for both allogeneic and autologous stem cell transplantation in patients with hematologic and non-hematologic malignancies.\n\nThe investigators have previously studied that conditioning regimen of i.v. busulfan/melphalan/etoposide (BuME) was well tolerated and effective in patients with relapsed or high risk NHL. And busulfan/cyclophosphamide/etoposide (BuCE) conditioning regimen has been extensively utilized in ASCT for NHL.\n\nTherefore, based on the encouraging results, the investigators will conduct a randomized phase II multicenter trial of BuCE versus BuME as conditioning therapy for ASCT in patients with NHL.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Histologically confirmed aggressive NHL\n2. Mantle cell lymphoma\n3. salvage chemotherapy sensitive relapse/refractory NHL or high risk NHL with remission in induction chemotherapy\n4. Performance status: Eastern Cooperative Oncology Group (ECOG) 0-2.\n5. Age; 18-65\n6. Adequate renal function: serum creatinine ≤ 1.5mg/dL\n7. Adequate liver functions: Transaminase (AST/ALT) \\< 3 X upper normal value \\& Bilirubin \\< 2 X upper normal value\n\nExclusion Criteria:\n\n1. low grade NHL\n2. Any other malignancies within the past 5 years except curatively treated non-melanoma skin cancer or in situ carcinoma of cervix uteri\n3. Other serious illness or medical conditions\n\n * Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry\n * History of significant neurological or psychiatric disorders\n * Active uncontrolled infection (viral, bacterial or fungal infection)\n4. Pregnant or lactating women, women of childbearing potential not employing adequate contraception\n5. HIV (+)\n6. Patients who have hepatitis B virus (HBV) (+) are eligible. However, primary prophylaxis using antiviral agents (i.e. lamivudine) is recommended for HBV carrier to prevent HBV reactivation during whole treatment period -'}, 'identificationModule': {'nctId': 'NCT03794167', 'acronym': 'CISL', 'briefTitle': "BuCE Versus BuME as Conditioning Therapy in Non-Hodgkin's Lymphoma", 'organization': {'class': 'OTHER', 'fullName': 'Soonchunhyang University Hospital'}, 'officialTitle': "Randomized Phase II Multi-center Trial of Busulfan, Etoposide, and Cyclophosphamide Versus Busulfan, Etoposide, and Melphalan as Conditioning Therapy for Autologous Stem-cell Transplantation(ASCT) in Patients With Non-Hodgkin's Lymphoma", 'orgStudyIdInfo': {'id': 'CISL 12-05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'busulfan cyclophosphamide etoposide', 'description': 'busulfan 3.2 mg/kg/day i.v. on days -8,-7, and -6, cyclophosphamide 50mg/kg/day i.v. on days -3 and -2 etoposide 400mg/m2 day i.v. on days -5 and -4', 'interventionNames': ['Drug: Busulfan', 'Drug: Cyclophosphamide', 'Drug: Etoposide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'busulfan melphalan etoposide', 'description': 'busulfan 3.2 mg/kg/day i.v. on days -8,-7, and -6 melphalan 50mg/m2/day i.v. on days -3 and -2 etoposide 400mg/m2 day i.v. on days -5 and -4', 'interventionNames': ['Drug: Busulfan', 'Drug: Etoposide', 'Drug: Melphalan']}], 'interventions': [{'name': 'Busulfan', 'type': 'DRUG', 'otherNames': ['Busulfex'], 'description': 'busulfan 3.2 mg/kg/day i.v. on days -8,-7, and -6', 'armGroupLabels': ['busulfan cyclophosphamide etoposide', 'busulfan melphalan etoposide']}, {'name': 'Cyclophosphamide', 'type': 'DRUG', 'description': 'cyclophosphamide 50mg/kg/day i.v. on days -3 and -2', 'armGroupLabels': ['busulfan cyclophosphamide etoposide']}, {'name': 'Etoposide', 'type': 'DRUG', 'description': 'etoposide 400mg/m2 day i.v. on days -5 and -4', 'armGroupLabels': ['busulfan cyclophosphamide etoposide', 'busulfan melphalan etoposide']}, {'name': 'Melphalan', 'type': 'DRUG', 'otherNames': ['Alkeran'], 'description': 'melphalan 50mg/m2/day i.v. on days -3 and -2', 'armGroupLabels': ['busulfan melphalan etoposide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04401', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Jong-Ho Won', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Jong-Ho Won, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Soonchunhyang University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Soonchunhyang University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jong-Ho Won', 'investigatorAffiliation': 'Soonchunhyang University Hospital'}}}}