Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:02 AM
Study NCT ID:
NCT00558220
Status:
COMPLETED
Last Update Posted:
2007-11-14
First Post:
2007-02-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
R-MegaCHOP-ESHAP-BEAM in Patients With High-Risk Aggressive B-Cell Lymphomas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}, {'id': 'D016393', 'term': 'Lymphoma, B-Cell'}], 'ancestors': [{'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': 'D007167', 'term': 'Immunotherapy'}], 'ancestors': [{'id': 'D056747', 'term': 'Immunomodulation'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-11', 'completionDateStruct': {'date': '2006-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-11-10', 'studyFirstSubmitDate': '2007-02-12', 'studyFirstSubmitQcDate': '2007-11-10', 'lastUpdatePostDateStruct': {'date': '2007-11-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-11-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': '3 years'}], 'secondaryOutcomes': [{'measure': 'Complete remission and overall response rate', 'timeFrame': 'One year'}, {'measure': 'Overall survival', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Lymphoma, B-cell', 'Immunotherapy, passive', 'Remission induction', 'Autologous transplantation'], 'conditions': ['Diffuse Large B-Cell Lymphoma.', 'Primary Mediastinal B-Cell Lymphoma', 'Follicular Lymphoma Grade III']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.lymphoma.cz', 'label': 'Official Site of the Czech Lymphoma Study Group'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to show if addition of Rituximab to intensive induction (MegaCHOP/ESHAP) and high-dose consolidation (BEAM) improves progression-free and overall survival in patients younger than 65 years with aggressive B-cell lymphoma and aaIPI 2 or 3.', 'detailedDescription': 'Previous study of Czech Lymphoma Study Group (4\\_2002)have shown that intensive induction (MegaCHOP - Cyclophosphamide 3 g/m2, Vincristine 2 mg, Adriamycin 75 mg/m2, Prednisone 300 mg/m2 every three weeks with G-CSF for three cycles, followed by ESHAP - Etoposide 240 mg/m2, Cisplatin 100 mg/m2, Solumedrol 2000 mg and cytarabine 2000 mg/m2 for three cycles every three weeks with G-CSF) followed by intensive consolidation (BEAM) and stem cell support improves progression-free survival in adult patients (18-65 years old) with aggressive B-cell lymphoma (namely, diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma and follicular lymphoma grade II) with aaIPI 2 and namely, with aaIPI 3. This study was aimed to find out if addition of four to six doses of Rituximab 375 mg/m2 on first day of every cycle of intensive induction further improves prognosis of these patients.\n\nInclusion criteria for this trial were:\n\n* newly diagnosed aggressive B-cell lymphoma, namely diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma and follicular lymphoma grade III\n* age 18-65 years\n* age adjusted IPI (International Prognostic Index) score 2 or 3\n* ECOG performance status 0-3\n* signed informed consent\n\nExclusion criteria were:\n\n* relapsed lymphoma\n* previous treatment (up to one cycle of standard pretreatment - COP, CHOP or steroids was permitted and later became mandatory to decrease disease burden and/or improve the performance status of the patient)\n* Burkitt lymphoma\n* posttransplant lymphoproliferation\n* CNS involvement\n* other malignant tumor in previous history, except basalioma, skin squamocellular carcinoma or cervical carcinoma in situ\n* other serious comorbidity\n\nPrimary endpoints was progression-free survival\n\nSecondary endpoints were:\n\n* rate of complete remission and overall response rate\n* overall survival\n* toxicity of the protocol, measured as grade III-IV toxicity and/or inability to finish the protocol as planned\n\nPlanned number of accrued patients was 100.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aggressive B-cell lymphoma, namely diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, follicular lymphoma grade III\n* Age 18-65 years\n* Age-adjusted IPI score 2-3\n* ECOG performance status 0-3\n* Signed informed consent\n\nExclusion Criteria:\n\n* Burkitt lymphoma\n* Posttransplant lymphoproliferation\n* Previous treatment (up to one cycle of standard pretreatment with COP, CHOP or steroids permitted and latter mandatory to decrease tumor burden and/or improve performance status)\n* Other tumor in previous history with the exception of basalioma, squamous cell carcinoma of the skin or cervical carcinoma in situ\n* Pregnancy/lactation\n* CNS involvement\n* Other serious comorbidities'}, 'identificationModule': {'nctId': 'NCT00558220', 'acronym': 'R-MCEB', 'briefTitle': 'R-MegaCHOP-ESHAP-BEAM in Patients With High-Risk Aggressive B-Cell Lymphomas', 'organization': {'class': 'OTHER', 'fullName': 'Czech Lymphoma Study Group'}, 'officialTitle': 'Phase II Study of Intensive Induction (R-MegaCHOP/ESHAP)Followed By Intensive Consolidation (BEAM) In Treatment Of High-Risk Aggressive B-Cell Lymphomas', 'orgStudyIdInfo': {'id': 'CLSG 5_02'}, 'secondaryIdInfos': [{'id': 'NR-8231/3'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'Intensive induction followed by high-dose consolidation with stem cell support ± radiotherapy', 'interventionNames': ['Procedure: immunotherapy', 'Procedure: Induction treatment part 1', 'Procedure: Induction treatment part 2 with PBPC collection', 'Procedure: Induction treatment part 3', 'Procedure: Consolidation treatment part 1: HD-chemotherapy with ASCT', 'Radiation: Consolidation treatment part 2: Radiotherapy']}], 'interventions': [{'name': 'immunotherapy', 'type': 'PROCEDURE', 'description': 'Given together with induction chemotherapy:\n\nRituximab - 375 mg/m2 iv every 3 weeks, 4-6 doses', 'armGroupLabels': ['A']}, {'name': 'Induction treatment part 1', 'type': 'PROCEDURE', 'description': 'cyclophosphamide 3000 mg/m2 iv every 3 weeks, 3 cycles vincristin 2 mg iv every 3 weeks, 3 cycles doxorubicin 75 mg/m2 iv every 3 weeks, 3 cycles Prednisolone 300 mg/m2 divided into five days po every 3 weeks, 3 cycles pegfilgrastim 6 mg sc every 3 weeks.\n\n3 cycles consisting of combination treatment of above mentioned drugs are given.', 'armGroupLabels': ['A']}, {'name': 'Induction treatment part 2 with PBPC collection', 'type': 'PROCEDURE', 'description': 'Starts three weeks after last cycle of Induction part 1.\n\nEtoposide 240 mg/m2 divided into equal doses for four days, together with methylprednisolone 2000 mg divided into equal doses for four days, together with cisplatin 100 mg/m2 divided into equal doses for four days, and together with cytarabine 2000 mg/m2 iv one dose on 4th day of treatment. Filgrastim 10-12 ug/kg from day five after start of chemotherapy untill stem cell collection.\n\nPeripheral blood progenitor cell collection (PBPC) is started when CD34 positive cells are \\>20/cubic milimeter of blood and continued untill 5 million of CD34 positive cells are collected from peripheral blood.', 'armGroupLabels': ['A']}, {'name': 'Induction treatment part 3', 'type': 'PROCEDURE', 'description': 'Part 3 of induction treatment is given approximately one week after the end of Part 2.\n\nEtoposide 240 mg/m2 divided into equal doses for four days, methylprednisolone 2000 mg divided into equal doses for four days, cisplatin 100 mg/m2 divided into equal doses for four days, cytarabine 2000 mg/m2 iv one dose on day 4 of chemotherapy and pegfilgrastim 6 mg on day five of chemotherapy are given twice three weeks apart.', 'armGroupLabels': ['A']}, {'name': 'Consolidation treatment part 1: HD-chemotherapy with ASCT', 'type': 'PROCEDURE', 'description': 'Consolidation treatment Part 1 starts 4-8 weeks after the second cycle of Induction treatment Part 3.\n\nHigh dose chemotherapy (HD-chemotherapy) consists of:\n\nBCNU 300 mg/m2 is given on day 1, etoposide 800 mg/m2 divided into four equal doses is given on day 2-5, cytarabine 1600 mg/m2 divided into eight equal doses is given on day 2-5, melphalan 140 mg/m2 is given on day 6.\n\nOn day 7, collected stem cells from peripheral blood (see Induction treatment part 1) are infused back to the patient. This is called autologous transplantation (ASCT). Filgrastim 5 ug/kg is given from day 14 (start of the chemotherapy being day 1) until neutrophil recovery.', 'armGroupLabels': ['A']}, {'name': 'Consolidation treatment part 2: Radiotherapy', 'type': 'RADIATION', 'description': 'Radiotherapy is started given 4-8 weeks after the autologous transplantation. It is given to patients with initially bulky disease (\\>10 cm at diagnosis) or to patients with residual disease after Induction treatment part 1-3 and Consolidation treatment part 1. 30-40 Gy are given in 2 Gy fractions over 3-4 weeks.', 'armGroupLabels': ['A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '625 00', 'city': 'Brno', 'country': 'Czechia', 'facility': 'University Hospital Brno-Bohunice', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'zip': '430 12', 'city': 'Chomutov', 'country': 'Czechia', 'facility': 'Hospital Chomutov', 'geoPoint': {'lat': 50.46048, 'lon': 13.41779}}, {'city': 'České Budějovice', 'country': 'Czechia', 'facility': 'Hospital České Budějovice', 'geoPoint': {'lat': 48.97447, 'lon': 14.47434}}, {'zip': '500 05', 'city': 'Hradec Králové', 'country': 'Czechia', 'facility': 'University Hospital Hradec Králové', 'geoPoint': {'lat': 50.20923, 'lon': 15.83277}}, {'zip': '100 34', 'city': 'Prague', 'country': 'Czechia', 'facility': 'University Hospital Královské Vinohrady', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '128 08', 'city': 'Prague', 'country': 'Czechia', 'facility': 'General University Hospital', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '150 00', 'city': 'Prague', 'country': 'Czechia', 'facility': 'University Hospital Motol', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '401 13', 'city': 'Ústí nad Labem', 'country': 'Czechia', 'facility': 'Hospital Ústí nad Labem', 'geoPoint': {'lat': 50.6607, 'lon': 14.03227}}], 'overallOfficials': [{'name': 'Pytlik Robert, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': '1st Department of Medicine, General University Hospital, Prague'}, {'name': 'Marek Trněný, M.D., PhD.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'General University Hospital, Prague'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Czech Lymphoma Study Group', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health, Czech Republic', 'class': 'OTHER_GOV'}, {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}]}}}