Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 11:26 PM
Study NCT ID:
NCT00388193
Status:
COMPLETED
Last Update Posted:
2014-10-28
First Post:
2006-10-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Rituximab Combined With Chemotherapy in Burkitt's Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D002051', 'term': 'Burkitt Lymphoma'}], 'ancestors': [{'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D020031', 'term': 'Epstein-Barr Virus Infections'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069283', 'term': 'Rituximab'}], 'ancestors': [{'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': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-27', 'studyFirstSubmitDate': '2006-10-13', 'studyFirstSubmitQcDate': '2006-10-13', 'lastUpdatePostDateStruct': {'date': '2014-10-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-10-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determinate the efficacy of the administration of anti-CD20 (RITUXIMAB) combined with chemotherapy.', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Combined treatment with high doses of methotrexate and high doses of cytarabine with conventional cytostatics (block C)', 'timeFrame': '1 year'}, {'measure': 'Prophylactic administration of G-CSF after all chemotherapy cycles', 'timeFrame': '1 year'}, {'measure': 'local irradiation after 6 cycle if CNS was affected or if there are residual tumour', 'timeFrame': '1 year'}]}, 'conditionsModule': {'keywords': ['ALL (L3)', "BURKITT's LYMPHOMA", 'RITUXIMAB'], 'conditions': ['Acute Lymphoblastic Leukemia', "Burkitt's Lymphoma"]}, 'referencesModule': {'references': [{'pmid': '8555471', 'type': 'BACKGROUND', 'citation': 'Hoelzer D, Ludwig WD, Thiel E, Gassmann W, Loffler H, Fonatsch C, Rieder H, Heil G, Heinze B, Arnold R, Hossfeld D, Buchner T, Koch P, Freund M, Hiddemann W, Maschmeyer G, Heyll A, Aul C, Faak T, Kuse R, Ittel TH, Gramatzki M, Diedrich H, Kolbe K, Fuhr HG, Fischer K, Schadeck-Gressel C, Weiss A, Strohscheer I, Metzner B, Fabry U, Gokbuget N, Volkers B, Messerer D, Uberla K. Improved outcome in adult B-cell acute lymphoblastic leukemia. Blood. 1996 Jan 15;87(2):495-508.'}, {'pmid': '10552938', 'type': 'BACKGROUND', 'citation': 'Reiter A, Schrappe M, Tiemann M, Ludwig WD, Yakisan E, Zimmermann M, Mann G, Chott A, Ebell W, Klingebiel T, Graf N, Kremens B, Muller-Weihrich S, Pluss HJ, Zintl F, Henze G, Riehm H. Improved treatment results in childhood B-cell neoplasms with tailored intensification of therapy: A report of the Berlin-Frankfurt-Munster Group Trial NHL-BFM 90. Blood. 1999 Nov 15;94(10):3294-306.'}, {'pmid': '10561310', 'type': 'BACKGROUND', 'citation': "Thomas DA, Cortes J, O'Brien S, Pierce S, Faderl S, Albitar M, Hagemeister FB, Cabanillas FF, Murphy S, Keating MJ, Kantarjian H. Hyper-CVAD program in Burkitt's-type adult acute lymphoblastic leukemia. J Clin Oncol. 1999 Aug;17(8):2461-70. doi: 10.1200/JCO.1999.17.8.2461."}, {'pmid': '9578060', 'type': 'BACKGROUND', 'citation': 'Adde M, Shad A, Venzon D, Arndt C, Gootenberg J, Neely J, Nieder M, Owen W, Seibel N, Wilson W, Horak ID, Magrath I. Additional chemotherapy agents improve treatment outcome for children and adults with advanced B-cell lymphomas. Semin Oncol. 1998 Apr;25(2 Suppl 4):33-9; discussion 45-8.'}, {'pmid': '12576316', 'type': 'BACKGROUND', 'citation': 'Mounier N, Briere J, Gisselbrecht C, Emile JF, Lederlin P, Sebban C, Berger F, Bosly A, Morel P, Tilly H, Bouabdallah R, Reyes F, Gaulard P, Coiffier B. Rituximab plus CHOP (R-CHOP) overcomes bcl-2--associated resistance to chemotherapy in elderly patients with diffuse large B-cell lymphoma (DLBCL). Blood. 2003 Jun 1;101(11):4279-84. doi: 10.1182/blood-2002-11-3442. Epub 2003 Feb 6.'}, {'pmid': '11600602', 'type': 'BACKGROUND', 'citation': 'Lee EJ, Petroni GR, Schiffer CA, Freter CE, Johnson JL, Barcos M, Frizzera G, Bloomfield CD, Peterson BA. Brief-duration high-intensity chemotherapy for patients with small noncleaved-cell lymphoma or FAB L3 acute lymphocytic leukemia: results of cancer and leukemia group B study 9251. J Clin Oncol. 2001 Oct 15;19(20):4014-22. doi: 10.1200/JCO.2001.19.20.4014.'}, {'pmid': '10552937', 'type': 'BACKGROUND', 'citation': 'Zinzani PL, Martelli M, Magagnoli M, Pescarmona E, Scaramucci L, Palombi F, Bendandi M, Martelli MP, Ascani S, Orcioni GF, Pileri SA, Mandelli F, Tura S. Treatment and clinical management of primary mediastinal large B-cell lymphoma with sclerosis: MACOP-B regimen and mediastinal radiotherapy monitored by (67)Gallium scan in 50 patients. Blood. 1999 Nov 15;94(10):3289-93.'}, {'pmid': '12681972', 'type': 'BACKGROUND', 'citation': 'Oriol A, Ribera JM, Esteve J, Sanz MA, Brunet S, Garcia-Boyero R, Fernandez-Abellan P, Marti JM, Abella E, Sanchez-Delgado M, Penarrubia MJ, Besalduch J, Moreno MJ, Borrego D, Feliu E, Ortega JJ; PETHEMA Group, Spanish Society of Hematology. Lack of influence of human immunodeficiency virus infection status in the response to therapy and survival of adult patients with mature B-cell lymphoma or leukemia. Results of the PETHEMA-LAL3/97 study. Haematologica. 2003 Apr;88(4):445-53.'}], 'seeAlsoLinks': [{'url': 'http://www.aehh.org', 'label': 'Spanish association of Haematology'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical trial is to prove the efficacy of the following new regimen treatment:\n\n* Administration of anti-CD20 (Rituximab) combined with chemotherapy.\n* Combined treatment with high doses of methotrexate and high doses of cytarabine with conventional cytostatics (block C)\n* Prophylactic administration of G-CSF after all chemotherapy cycles\n* local irradiation after 6 cycle if CNS was affected or if there are residual tumour', 'detailedDescription': 'Clinical Trial with a pharmaceutical speciality in new conditions to use.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients diagnosed with mature LLA-B cell (LLA-L3)\n* Patients diagnosed with Burkitt´s and Burkitt´s Like Lymphoma\n* Patients 15 years old or up\n* Written Informed Consent signed\n\nExclusion Criteria:\n\n* Serious complications related with LAL3/LB or Secondary illness:\n\nSerious complications, uncontrollable, for example, sepsis, pneumonia with hypoxia, shock, haemorrhage at diagnosis.\n\n* Renal failure unconditional for the Lymphoma/Leukemia\n* Heart failure or serious liver.\n* Pulmonary obstructive disease or serious restrictive that not allow to treat the patient with intensive chemotherapy.\n* Secondary Lymphoma after chemotherapy or previous radiotherapy or second malignant tumour.\n* Known hypersensitivity to any foreign protein.\n* Previous treatment with cytostatics of the LLA-B or Burkitt´s Lymphoma (exception: administration on short time of glucocorticoids ≤ 7 days, one administration of vincristine or cyclophosphamide, one cycle of CHOP, urgent administration of the another cytostatics).\n* With another malignant tumour in the last 5 year.\n* Women in fertile age must give positive in the pregnancy test or nursing mother.\n* Mental disability or emotional or psychiatric significant disorder were the patient can't understand nor cooperate with treatment.\n* Patients is enrolled in another clinical research study."}, 'identificationModule': {'nctId': 'NCT00388193', 'briefTitle': "Rituximab Combined With Chemotherapy in Burkitt's Lymphoma", 'organization': {'class': 'OTHER', 'fullName': 'PETHEMA Foundation'}, 'officialTitle': "Burkimab:Study Multicenter of Optimization of the Treatment of LLA-B and the Burkitt's Lymphoma in Adult Patients (From 15 Years Old)", 'orgStudyIdInfo': {'id': '2005-001067-64'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: RITUXIMAB']}], 'interventions': [{'name': 'RITUXIMAB', 'type': 'DRUG', 'description': '375 mg/m2/d day 1', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alicante', 'state': 'Alicante', 'country': 'Spain', 'facility': 'Hospital General de Alicante', 'geoPoint': {'lat': 38.34517, 'lon': -0.48149}}, {'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital "Santa Creu i Sant Pau"', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clínico y Provincial de Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'A Coruña', 'state': 'La Coruña', 'country': 'Spain', 'facility': 'Hospital Juan Canalejo', 'geoPoint': {'lat': 43.37135, 'lon': -8.396}}, {'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Clínico San Carlos de Madrid', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Doce de Octubre', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Murcia', 'state': 'Murcia', 'country': 'Spain', 'facility': 'Hospital Universitario Morales Meseguer, Murcia', 'geoPoint': {'lat': 37.98704, 'lon': -1.13004}}, {'city': 'Málaga', 'state': 'Málaga', 'country': 'Spain', 'facility': 'Hospital Carlos Haya', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'city': 'Palma de Mallorca', 'state': 'Palma de Mallorca', 'country': 'Spain', 'facility': 'Hospital Son Dureta', 'geoPoint': {'lat': 39.56939, 'lon': 2.65024}}, {'city': 'Seville', 'state': 'Sevilla', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen del Rocío', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'city': 'Valencia', 'state': 'Valencia', 'country': 'Spain', 'facility': 'Hospital La Fe', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'city': 'Cáceres', 'country': 'Spain', 'facility': 'Complejo Hospitalario de Cáceres', 'geoPoint': {'lat': 39.47649, 'lon': -6.37224}}, {'city': 'Jerez de la Frontera', 'country': 'Spain', 'facility': 'Hospital general de Jerez de la Frontera', 'geoPoint': {'lat': 36.68645, 'lon': -6.13606}}, {'city': 'Salamanca', 'country': 'Spain', 'facility': 'Hospital Clínico Universitario de Salamanca', 'geoPoint': {'lat': 40.42972, 'lon': -3.67975}}, {'city': 'Vitoria-Gasteiz', 'country': 'Spain', 'facility': 'Hospital Txagorritxu', 'geoPoint': {'lat': 42.84998, 'lon': -2.67268}}], 'overallOfficials': [{'name': 'Ribera Josep Mª, Dr', 'role': 'STUDY_CHAIR', 'affiliation': 'Germans Trias i Pujol Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'PETHEMA Foundation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}