Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-27 @ 11:24 PM
Study NCT ID:
NCT01679860
Status:
COMPLETED
Last Update Posted:
2012-09-06
First Post:
2012-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intensive Chemo-immunotherapy as First Line Treatment in Adult Patients With Peripheral T- Cell Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016411', 'term': 'Lymphoma, T-Cell, Peripheral'}], 'ancestors': [{'id': 'D016399', 'term': 'Lymphoma, T-Cell'}, {'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': 'D000074323', 'term': 'Alemtuzumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'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': {'type': 'ACTUAL', 'count': 92}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-03', 'studyFirstSubmitDate': '2012-08-30', 'studyFirstSubmitQcDate': '2012-09-03', 'lastUpdatePostDateStruct': {'date': '2012-09-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy', 'timeFrame': 'one year', 'description': 'number of clinical responses'}], 'secondaryOutcomes': [{'measure': 'evaluation of OS (overall survival)', 'timeFrame': '4 years', 'description': 'OS time is calculated from patients enrollment to death for all causes; censored cases are pts alive at the date of last follow-up assessment.'}, {'measure': 'DFS (Disease Free Survival)', 'timeFrame': '4 years', 'description': 'DFS time is the interval between CR achievement and the first disease relapse or death regardless of the cause.Definition of disease response/progression will be performed according to the criteria published by Juweid et al.(J Clin Oncol. 2005; 23: 4652-61)'}, {'measure': 'TRM (Treatment Related Mortality)', 'timeFrame': '4 years', 'description': 'TRM will be analysed by computing the corresponding crude cumulative incidence curve, considering disease-related death as competing event.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Lymphoma, T-Cell, Peripheral']}, 'descriptionModule': {'briefSummary': 'Peripheral T cell lymphomas (PTCL) are a rare hematologic disease. Five-year overall survival (OS) of PTCL patients (pts) ranges between 20 and 30%. Allogeneic stem cell transplantation (allo-STC) may have a curative role for these pts but its toxicity is high when myeloablative conditioning is used. Reduced intensity conditionings (RIC) can decrease transplant related toxicity and mortality. The investigators have recently proved feasibility and potential efficacy of a RIC regimen in relapsed PTCL patients.\n\nWe want to investigate whether it is possible to improve the outcome of alk negative PTCL pts, stage II-IV at diagnosis, by intensifying the therapeutic approach.\n\nThe intensification will be obtained by combining intensive chemotherapy, alemtuzumab (anti-CD52 humanised antibody) and auto- or allo-SCT in pts aged between 18 and 60 years (Clinical Study A) or adding alemtuzumab to standard chemotherapy (CHOP) in pts aged between 61 and 70 years(Clinical Study B).', 'detailedDescription': 'Inclusion criteria Clin A\n\n* Age ≥18 \\< or =60 years (patients older than 60 years are excluded because of the intensive chemotherapy and transplant procedures)\n* Histologically proven diagnosis of PTCL, including the following categories: PTCL-U (peripheral T-cell lymphoma, unspecified), AILD-T (angioimmunoblastic-like T-cell lymphoma), ALKneg ALCL (ALK-negative anaplastic large cell lymphoma),intestinal T - NHL\n* Advanced stage disease (stage II-IV) or stage I and aaIPI score ≥ 2\n* Written informed consent\n\nInclusion criteria Clin B\n\n* Age \\>60 and ≤75 years (patients older than 75 years are excluded because of the intensive chemo-immunotherapy program)\n* Histological proven diagnosis of PTCL, including the following categories: PTCL-U (peripheral T-cell lymphoma, unspecified), AILD-T (angioimmunoblastic-like T-cell lymphoma), ALKneg ALCL (ALK-negative anaplastic large cell lymphoma), intestinal T - NHL\n* Advanced-stage disease (stage II-IV) or stage I and aaIPI score ≥ 2\n* Informed written consent\n\nIn clinical study A (Clin A) we are planning to evaluate the efficacy and the feasibility of an intensified chemo-immunotherapy program including auto-SCT or RIC allo-SCT in advanced stage PTCL pts ≥ 18 and \\< or = 60 years.\n\nIn clinical study B (Clin B) we intend to verify the efficacy and the feasibility of a combined immuno-chemotherapy approach in a subset of elderly pts aged \\> 60 and \\< or = 75 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 \\<60 years (patients older than 60 years are excluded because of the intensive chemotherapy and transplant procedures)\n* Histologically proven diagnosis of PTCL, including the following categories: PTCL-U (peripheral T-cell lymphoma, unspecified), AILD-T (angioimmunoblastic-like T-cell lymphoma), ALKneg ALCL (ALK-negative anaplastic large cell lymphoma),intestinal T - NHL\n* Advanced stage disease (stage II-IV) or stage I and aaIPI score ≥ 2\n* Written informed consent\n\nExclusion Criteria:\n\n* Histological PTCL subset other than PTCL-U, AILD-T ALCL-ALKneg, intestinal T - NHL\n* Central nervous system localization\n* Positive serologic markers for human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV) infection\n* Serum bilirubin levels \\> 2 the upper normal limit\n* Clearance of creatinine \\< 50 ml/min\n* DLCO \\< 50%\n* Ejection fraction \\< 45% (or myocardial infarction in the last 12 months)\n* Pregnancy or lactation\n* Patient not agreeing to take adequate contraceptive measures during the study\n* Psychiatric disease\n* Any active, uncontrolled infection\n* Type I hypersensitivity or anaphylactic reactions to proteins drugs\n* Active secondary malignancy'}, 'identificationModule': {'nctId': 'NCT01679860', 'acronym': 'PTCL-06', 'briefTitle': 'Intensive Chemo-immunotherapy as First Line Treatment in Adult Patients With Peripheral T- Cell Lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione IRCCS Istituto Nazionale dei Tumori, Milano'}, 'officialTitle': 'Intensive Chemo-immunotherapy as First-line Treatment in Adult Patients With Peripheral T-cell Lymphoma (PTCL)', 'orgStudyIdInfo': {'id': 'PTCL-062006-004234-33'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Clin A', 'description': 'Clin A. CHOP-Campath (CHOP-C) for 2 cycles , Hyper-C-Hidam for 2 cycles and auto-SCT (stem cell transplantation) or RIC allo-SCT in advanced stage PTCL pts ≥ 18 and ≤ 60 years', 'interventionNames': ['Procedure: Clin A. CHOP-CAMPATH (Chemo-immunotherapy) + SCT']}, {'type': 'EXPERIMENTAL', 'label': 'Clin B', 'description': 'Clin B: CHOP-Campath (CHOP-C) for 6 cycles . It is a combined immunochemotherapy approach in a subset of elderly pts aged \\> 60 ≤ 75 years', 'interventionNames': ['Drug: Clin B (CHOP- CAMPATH) Chemo-immunotherapy']}], 'interventions': [{'name': 'Clin A. CHOP-CAMPATH (Chemo-immunotherapy) + SCT', 'type': 'PROCEDURE', 'otherNames': ['Mab - Campath (Alemtuzumab)'], 'description': 'Clin A:\n\n* CHOP-Campath (CHOP-C) for 2 cycles (every 21 days): Doxorubicin 50mg/m2 day +1, Vincristin 1.4mg/m2 day +1, Cyclophosphamide 750mg/m2 day +1, prednisone 100mg/m2 PO on days +1 to +5; Campath-1H (alemtuzumab) dose escalation 3-10-20mg IV days - 2, - 1, 0 (first CHOP-C) or 30mg SC day 0 (second CHOP-C). Methotrexate 12.5mg IT, Ara-C 40mg IT, Dexamethasone 4mg IT on days + 1 and 21 (first and second CHOP-C).\n* HYPER-C-HiDAM for 2 cycles: Methotrexate 1.5gr/m2 day +1; Cyclophosphamide 300mg/m2 every 12 hours days +2-3-4; ARA-C 2gr/m2 every 12 hours days +2-3-4; G-CSF 5μcg/kg/day starting from day +5 until peripheral blood stem cell harvest\n* Myeloablative regimen followed by autologous transplantation or Reduced intensity conditioning followed by allogeneic transplantation.', 'armGroupLabels': ['Clin A']}, {'name': 'Clin B (CHOP- CAMPATH) Chemo-immunotherapy', 'type': 'DRUG', 'otherNames': ['Mab- Campath (Alemtuzumab)'], 'description': 'Clin B:\n\n* CHOP-Campath (CHOP-C) for 6 cycles (every 21 days): Doxorubicin 50mg/m2 day +1, Vincristin 1.4mg/m2 day +1, Cyclophosphamide 750mg/m2 day +1, prednisone 100mg/m2 PO from day +1 to day +5¸ Campath-1H (alemtuzumab) 3-10mg IV on days - 1 and 0 ( first CHOP-C course) or 10mg SC on day 0 (for the following 5 C-CHOP courses). Methotrexate 12.5mg IT, Ara-C 40mg IT, Dexamethasone 4mg IT on day +1 of each CHOP-C course.', 'armGroupLabels': ['Clin B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25123', 'city': 'Brescia', 'state': 'Brescia', 'country': 'Italy', 'facility': 'Spedali Civili di Brescia', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}, {'zip': '94124', 'city': 'Catania', 'state': 'Catania', 'country': 'Italy', 'facility': 'Azienda Ospedale Vittorio Emanuele Ferrarorro S. Bambino- Università di Catania', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}, {'zip': '85100', 'city': 'Potenza', 'state': 'Potenza', 'country': 'Italy', 'facility': 'Ospedale San Carlo', 'geoPoint': {'lat': 40.64175, 'lon': 15.80794}}, {'zip': '10043', 'city': 'Orbassano', 'state': 'Torino', 'country': 'Italy', 'facility': 'Azienda Ospedaliera S. Luigi', 'geoPoint': {'lat': 45.00547, 'lon': 7.53813}}, {'zip': '10126', 'city': 'Torino', 'state': 'Torino', 'country': 'Italy', 'facility': 'Azienda OspedalieraSan Giovanni Battista', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}, {'zip': '10126', 'city': 'Torino', 'state': 'Torino', 'country': 'Italy', 'facility': 'Università di Torino- Azienda Ospedaliera S. Giovanni Battista', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}, {'city': 'Udine', 'state': 'Udine', 'country': 'Italy', 'facility': 'Policlinico Universitario Udine', 'geoPoint': {'lat': 46.0693, 'lon': 13.23715}}, {'zip': '15100', 'city': 'Alessandria', 'country': 'Italy', 'facility': 'Ospedale SS. Antonio e Biagio e Cesare Arrigo', 'geoPoint': {'lat': 44.90924, 'lon': 8.61007}}, {'zip': '62020', 'city': 'Ancona', 'country': 'Italy', 'facility': 'University of Ancona - Division of Hematology', 'geoPoint': {'lat': 43.60717, 'lon': 13.5103}}, {'zip': '24128', 'city': 'Bergamo', 'country': 'Italy', 'facility': 'Ospedale Riuniti, Bergamo - Division of Hematology', 'geoPoint': {'lat': 45.69601, 'lon': 9.66721}}, {'zip': '39100', 'city': 'Bolzano', 'country': 'Italy', 'facility': 'Ospedale Generale Regionale Bolzano', 'geoPoint': {'lat': 46.49067, 'lon': 11.33982}}, {'zip': '12100', 'city': 'Cuneo', 'country': 'Italy', 'facility': 'Ospedale S. Croce - Division of Hematology', 'geoPoint': {'lat': 44.39071, 'lon': 7.54828}}, {'zip': '20100', 'city': 'Milan', 'country': 'Italy', 'facility': 'Ospedale San Raffaele, Milano - Division of Hematology', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '20133', 'city': 'Milan', 'country': 'Italy', 'facility': 'Division of Hematology - Fondazione IRCCS Istituto Nazionale Tumori', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '20122', 'city': 'Milan', 'country': 'Italy', 'facility': 'IRCCS Ospedale Maggiore Policlinico di Milano', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Palermo', 'country': 'Italy', 'facility': 'Ospedale Cervello - Bone Marrow Transplantation Unit', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}, {'zip': '37134', 'city': 'Verona', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Policlinico di Verona', 'geoPoint': {'lat': 45.43854, 'lon': 10.9938}}], 'overallOfficials': [{'name': 'paolo corradini', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'fondazione IRCCS istituto nazionale tumori Milano'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione IRCCS Istituto Nazionale dei Tumori, Milano', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director Hematology and BMT Unit', 'investigatorFullName': 'Paolo Corradini', 'investigatorAffiliation': 'Fondazione IRCCS Istituto Nazionale dei Tumori, Milano'}}}}