Ignite Creation Date:
2025-12-24 @ 7:42 PM
Ignite Modification Date:
2026-02-21 @ 11:18 PM
Study NCT ID:
NCT00866203
Status:
COMPLETED
Last Update Posted:
2009-03-20
First Post:
2007-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HDS Plus PBPC Transplant Vs 4 More Courses of FrontLine Therapy in Pts With Aggressive NHL in PR After Induction Therapy
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 441}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-03-19', 'studyFirstSubmitDate': '2007-03-13', 'studyFirstSubmitQcDate': '2009-03-19', 'lastUpdatePostDateStruct': {'date': '2009-03-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'remission duration', 'timeFrame': 'end of treatment'}, {'measure': 'overall survival', 'timeFrame': 'study end'}, {'measure': 'event-free survival', 'timeFrame': 'study end'}, {'measure': 'freedom-from progression', 'timeFrame': 'study end'}], 'secondaryOutcomes': [{'measure': 'feasibility and toxicity', 'timeFrame': 'end of treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['High-Grade Lymphomas']}, 'descriptionModule': {'briefSummary': 'The study is planned to compare the outcome of aggressive NHL patients in partial remission after four courses of front-line therapy, randomly assigned to receive either additional four courses of the same regimen or a modified HDS program.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Newly diagnosed, untreated patients with histologically documented aggressive lymphoma;\n* Age between 18 and 65 years;\n* Clinical stage at diagnosis: I A bulky - IV B;\n* Reduction of tumoral masses, after four courses of induction therapy, between 50 and 75%;\n* Serum negativity for HIV, HbsAg and HCV;\n* ECOG performance status 0 through 4;\n* Adequate bone marrow function;\n* Adequate renal and hepatic functions;\n* Left ventricular ejection fraction (LVEF) \\> 50%;\n* No previous malignant disease;\n* No previous chemo-radiotherapy;\n* No cerebral or CNS involvement, assessed by clinical history, physical examination and CSF examination through lumbar puncture;\n* Written informed consent given at time of randomization.\n\nExclusion Criteria:\n\n* Clinical stage I no bulky, or CS IIA-B with less than three sites of disease involved;\n* Patients with CR, unconfirmed complete remission (uCR), very good PR (\\>75%) and clinical response less than 50%, as defined by Cheson et al., following four courses of induction therapy;\n* Tumor involvement of CNS (except patients with peridural masses without liquor involvement , who can be enrolled in this study);\n* Indolent lymphoma transformed in more aggressive histologic type, even if never previously treated;\n* Aggressive non-Hodgkin's lymphoma in pre-transplanted patient;\n* Clinically significant secondary cardiovascular disease e.g. uncontrolled hypertension, (resting diastolic blood pressure \\> 115 mmHg), uncontrolled multifocal cardiac arrhythmias, symptomatic angina pectoris or congestive cardiac failure NYHA class III-IV;\n* Left ventricular ejection fraction (LVEF) \\< 50%;\n* Evidence of any severe active acute or chronic infection;\n* Concurrent malignancy of history of other malignancy, except basal cell carcinoma of the skin (BCC) and in situ cervical carcinoma (CIN);\n* myelodisplastic syndrome;\n* HbsAg, HIV-positive, or HCV-RNA-positive patients;\n* Patient with psychiatric, or any disorder that compromises ability to give truly informed consent for participation in this study;\n* Pregnant woman; potential child-bearing women can be enrolled if adequate contraceptive precautions are used before entering this trial and for the duration of the trial;\n* Concerns for patient's compliance with the protocol procedures."}, 'identificationModule': {'nctId': 'NCT00866203', 'briefTitle': 'HDS Plus PBPC Transplant Vs 4 More Courses of FrontLine Therapy in Pts With Aggressive NHL in PR After Induction Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Gruppo Italiano Studio Linfomi'}, 'officialTitle': 'A Prospective, Randomized, Multicenter Trial Comparing a Modified HDS Therapy Supported by PBPC Transplant With Additional 4 Courses of Front-Line Therapy in Adult Aggressive NHL With PR After Short Course of Up-Front Chemotherapy', 'orgStudyIdInfo': {'id': 'LA05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HDS', 'description': 'modified high dose sequential therapy', 'interventionNames': ['Drug: HDS vs ProMECE/CytaBOM']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ProMECE/CytaBOM', 'description': 'four additional courses of standard ProMECE/CytaBOM', 'interventionNames': ['Drug: HDS vs ProMECE/CytaBOM']}], 'interventions': [{'name': 'HDS vs ProMECE/CytaBOM', 'type': 'DRUG', 'armGroupLabels': ['HDS', 'ProMECE/CytaBOM']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41100', 'city': 'Modena', 'country': 'Italy', 'facility': 'GISL Trial Office', 'geoPoint': {'lat': 44.64783, 'lon': 10.92539}}], 'overallOfficials': [{'name': 'Nicola Di Renzo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'GISL'}, {'name': 'Massimo Federico, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'GISL'}, {'name': 'Maura Brugiatelli, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'GISL'}, {'name': 'Mario Petrini, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'GISL'}, {'name': 'Paolo G Gobbi, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'GISL'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gruppo Italiano Studio Linfomi', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'sponsor', 'oldOrganization': 'Gruppo Italiano Studio Linfomi'}}}}