Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2025-12-26 @ 4:26 AM
Study NCT ID:
NCT00244127
Status:
UNKNOWN
Last Update Posted:
2005-10-28
First Post:
2005-10-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Open Label, Single Arm, Phase II Study Using R-COMP in Elderly Patients With Aggressive NHL.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D014750', 'term': 'Vincristine'}, {'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D011241', 'term': 'Prednisone'}, {'id': 'D000069283', 'term': 'Rituximab'}], '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': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D058846', 'term': 'Antibodies, Monoclonal, Murine-Derived'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 75}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2002-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-10', 'lastUpdateSubmitDate': '2005-10-26', 'studyFirstSubmitDate': '2005-10-24', 'studyFirstSubmitQcDate': '2005-10-24', 'lastUpdatePostDateStruct': {'date': '2005-10-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-10-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response rate'}]}, 'conditionsModule': {'conditions': ["Aggressive Non-Hodgkin's Lymphoma in the Elderly."]}, 'descriptionModule': {'briefSummary': 'To evaluate the safety and efficacy of R-COMP in elderly patients with advanced aggressive NHL. Myocet (non-pegylated liposomal doxorubicin) replaces conventional doxorubicin in the R-CHOP regimen.', 'detailedDescription': 'To evaluate the duration of remission, disease free survival and 2-year survival of R-COMP in first line therapy of elderly patients with advanced aggressive NHL.\n\nTo evaluate the tolerability of R-COMP in first line therapy of elderly patients with advanced aggressive NHL.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diffuse Large B-Cell Lymphoma (DLBCL), and their morphologic variants and subtypes, i.e. Centroblastic lymphoma, Immunoblastic lymphoma, T-cell rich/B-cell lymphoma, anaplastic large B-cell lymphoma, mediastinal (thymic) large B-cell lymphoma;\n* Primary diffuse large B-cell lymphoma of MALT (incorrectly defined as high-grade MALT lymphoma);\n* Marginal zone B-cell lymphoma with coexisting areas of DLBCL;\n* Age of ≥60 years;\n* Clinical stage at diagnosis: I A bulky - IV B;\n* CD20 positivity;\n* Serum negativity for HbsAg and HCV except for those with no sign of active viral replication, assessed by HCV-RNA copies;\n* Absolute neutrophil count (ANC) ≥1.5x109/L, and platelet count ≥100x109/L (unless both are attributed directly to bone marrow involvement by lymphoma or auto-immune disease secondary to lymphoma);\n* Serum creatinine ≤130μM/L, serum bilirubin ≤2.5xULN aspartate amino-transferase (AST/GOT), ≤2.5xULN alanine amino-transferase (ALT/GPT) ≤2.5xULN, and alkaline phosphatase ≤4 times the upper limit of normal (unless the increase is attributed directly to the presence of tumour by the Investigator)\n* Left ventricular ejection fraction (LVEF) ≥50%;\n* ECOG performance status 0-2;\n* At least one measurable lesion is mandatory;\n* Written informed consent given at time of registration;\n* Males and females (both males and females of childbearing potential must agree to use adequate contraception for the duration, and for 3 months after the completion, of the treatment).\n\nExclusion Criteria:\n\n* Clinical stage I non-bulky, or CS IIA with less than three sites of disease involved (patients with stage IIB are eligible, regardless of the number of sites involved);\n* Tumour involvement of CNS;\n* Indolent lymphoma transformed in more aggressive histological type, even if never previously treated;\n* Mantle Cell Lymphoma, Peripheral T cell Lymphoma and their variants;\n* Aggressive non-Hodgkin's lymphoma in 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* Evidence of any severe active acute or chronic infection;\n* Concurrent malignancy or history of other malignancy, except basal cell carcinoma of the skin (BCC) and in-situ cervical carcinoma (CIN) / Myelodysplastic syndrome;\n* HbsAg, HIV-positive, or HCV-RNA-positive patients;\n* Inability to comply with study procedures;\n* Prior CNS lymphoma;\n* Prior radiation to non-CNS lymphoma mass(es) as a treatment for lymphomas;\n* History of allergic reaction to anthracyclines, eggs, and egg products or known sensitivities, or history of unusual reaction, to other components of, or treatments similar to, the investigational treatment regimen;\n* Presence of other medication that may interfere with study treatment or the action of the investigational product or confuse the assessment of study results\n* Pregnant women or nursing mothers;\n* Participation in an investigational drug study within 4 weeks prior to study entry."}, 'identificationModule': {'nctId': 'NCT00244127', 'briefTitle': 'Open Label, Single Arm, Phase II Study Using R-COMP in Elderly Patients With Aggressive NHL.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zeneus Pharma'}, 'officialTitle': 'Cyclophosphamide, Oncovin, Myocet, Prednisone and Rituximab (R-COMP) in the Treatment of Elderly Patients With Aggressive NHL.', 'orgStudyIdInfo': {'id': 'Myocet 018'}, 'secondaryIdInfos': [{'id': 'The MYOCAN Study'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Cyclophosphamide, oncovin, myocet, prednisone & rituximab (R-COMP)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Paris', 'country': 'France', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Berlin', 'country': 'Germany', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '41100', 'city': 'Modena', 'country': 'Italy', 'facility': 'Universita Degli Studi Di Modena AZ Ospedaliere Policlinico', 'geoPoint': {'lat': 44.64783, 'lon': 10.92539}}, {'city': 'Barcelona', 'country': 'Spain', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Leicester', 'country': 'United Kingdom', 'geoPoint': {'lat': 52.6386, 'lon': -1.13169}}], 'overallOfficials': [{'name': 'Massimo Federico', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universita Degli Studi di Modena'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zeneus Pharma', 'class': 'INDUSTRY'}}}}