Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-25 @ 9:29 PM
Study NCT ID:
NCT00012051
Status:
COMPLETED
Last Update Posted:
2013-08-12
First Post:
2001-03-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Chemotherapy and Peripheral Stem Cell Transplant With or Without Monoclonal Antibody Therapy in Treating Patients With Non-Hodgkin's Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D008224', 'term': 'Lymphoma, Follicular'}, {'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}], 'ancestors': [{'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'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D016393', 'term': 'Lymphoma, B-Cell'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069585', 'term': 'Filgrastim'}, {'id': 'D000069283', 'term': 'Rituximab'}, {'id': 'D002330', 'term': 'Carmustine'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D003561', 'term': 'Cytarabine'}, {'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D005047', 'term': 'Etoposide'}, {'id': 'D007069', 'term': 'Ifosfamide'}, {'id': 'D008558', 'term': 'Melphalan'}, {'id': 'D008727', 'term': 'Methotrexate'}, {'id': 'D036102', 'term': 'Peripheral Blood Stem Cell Transplantation'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D016179', 'term': 'Granulocyte Colony-Stimulating Factor'}, {'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'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': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D009607', 'term': 'Nitrosourea Compounds'}, {'id': 'D014508', 'term': 'Urea'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009603', 'term': 'Nitroso Compounds'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001087', 'term': 'Arabinonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D011034', 'term': 'Podophyllotoxin'}, {'id': 'D013764', 'term': 'Tetrahydronaphthalenes'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D010078', 'term': 'Oxazines'}, {'id': 'D010649', 'term': 'Phenylalanine'}, {'id': 'D024322', 'term': 'Amino Acids, Aromatic'}, {'id': 'D000598', 'term': 'Amino Acids, Cyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D018380', 'term': 'Hematopoietic Stem Cell Transplantation'}, {'id': 'D033581', 'term': 'Stem Cell Transplantation'}, {'id': 'D017690', 'term': 'Cell Transplantation'}, {'id': 'D064987', 'term': 'Cell- and Tissue-Based Therapy'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D014180', 'term': 'Transplantation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 340}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-03', 'completionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-09', 'studyFirstSubmitDate': '2001-03-03', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2013-08-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival'}], 'secondaryOutcomes': [{'measure': 'Response rate'}, {'measure': 'Event-free survival'}]}, 'conditionsModule': {'keywords': ['recurrent grade 3 follicular lymphoma', 'recurrent adult diffuse large cell lymphoma'], 'conditions': ['Lymphoma']}, 'referencesModule': {'references': [{'pmid': '17971487', 'type': 'RESULT', 'citation': "Vellenga E, van Putten WL, van 't Veer MB, Zijlstra JM, Fibbe WE, van Oers MH, Verdonck LF, Wijermans PW, van Imhoff GW, Lugtenburg PJ, Huijgens PC. Rituximab improves the treatment results of DHAP-VIM-DHAP and ASCT in relapsed/progressive aggressive CD20+ NHL: a prospective randomized HOVON trial. Blood. 2008 Jan 15;111(2):537-43. doi: 10.1182/blood-2007-08-108415. Epub 2007 Oct 30."}]}, 'descriptionModule': {'briefSummary': "RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Peripheral stem cell transplant may be able to replace immune cells that were destroyed by the chemotherapy. Monoclonal antibodies, such as rituximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known if giving more than one drug (combination chemotherapy) plus peripheral stem cell transplant is more effective with or without monoclonal antibody therapy in treating non-Hodgkin's lymphoma.\n\nPURPOSE: This randomized phase III trial is studying how well chemotherapy plus peripheral stem cell transplant with or without monoclonal antibody therapy works in treating patients with relapsed non-Hodgkin's lymphoma.", 'detailedDescription': "OBJECTIVES:\n\n* Compare the partial and complete response rates in patients with relapsed, CD20 positive, aggressive B-cell non-Hodgkin's lymphoma treated with dexamethasone, cisplatin, and cytarabine in combination with etoposide, ifosfamide, and methotrexate with or without rituximab followed by carmustine, etoposide, cytarabine, melphalan, and autologous peripheral blood stem cell transplantation (APBSCT).\n* Compare the effect of APBSCT with or without rituximab on the overall and event-free survival of these patients.\n\nOUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center. Patients are randomized to one of two treatment arms.\n\n* Arm I: Patients receive DHAP induction chemotherapy comprising dexamethasone orally or IV on days 1-4, cisplatin IV continuously over 24 hours on day 1, and cytarabine IV over 3 hours every 12 hours on day 2. Beginning 3-4 weeks after DHAP, patients receive VIM induction chemotherapy comprising etoposide IV over 2 hours on days 1, 3, and 5; ifosfamide IV over 1 hour on days 1-5; and methotrexate IV on days 1 and 5. Beginning 3-4 weeks after VIM, patients with partial or complete response after DHAP and VIM receive a second course of DHAP (patients with progressive or unresponsive disease after DHAP but responsive disease after VIM receive a second course of VIM) followed by filgrastim (G-CSF) subcutaneously beginning on day 10 and continuing until a target number of cells are collected.\n* Arm II: Patients receive induction chemotherapy and G-CSF as in arm I. At 1 day after the last dose of each chemotherapy course, patients also receive rituximab IV once for a maximum of 3 courses.\n\nAt 4-5 weeks after the completion of the last induction chemotherapy course, responsive patients in both arms receive BEAM conditioning chemotherapy comprising carmustine IV over 60 minutes on day -6, etoposide IV over 60 minutes and cytarabine IV over 30 minutes on days -5 to -2, and melphalan IV over 15 minutes on day -1. Patients undergo autologous peripheral blood stem cell transplantation on day 0. After transplantation, patients in partial remission may undergo radiotherapy to nodal sites with residual tumor mass.\n\nPatients are followed every 6 months for 3 years and then annually thereafter.\n\nPROJECTED ACCRUAL: A total of 296-340 patients (148-170 per treatment arm) will be accrued for this study within 4-5 years."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Histologically confirmed relapsed B-cell non-Hodgkin's lymphoma (NHL)\n\n * Diffuse large cell B-cell lymphoma\n * Grade III follicular center-cell lymphoma\n * Primary mediastinal B-cell lymphoma\n* CD20 positive\n* First relapse after doxorubicin containing regimen\n* Documented remission of at least 3 months after first-line chemotherapy\n* No Epstein-Barr virus post-transplantation lymphoproliferative disorder\n* No CNS involvement\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 to 65\n\nPerformance status:\n\n* WHO 0-1\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* Not specified\n\nHepatic:\n\n* No hepatic dysfunction\n* Bilirubin less than 2.5 times upper limit of normal (ULN)\n* Transaminases less than 2.5 times ULN\n\nRenal:\n\n* No renal dysfunction\n* Creatinine less than 2.0 mg/dL OR\n* Creatinine clearance greater than 40 mL/min\n\nCardiovascular:\n\n* No severe cardiac dysfunction\n* No New York Heart association class II-IV heart disease\n\nPulmonary:\n\n* No severe pulmonary dysfunction\n* Vital capacity or diffusion capacity at least 70% predicted unless related to NHL involvement\n\nOther:\n\n* No active uncontrolled infection\n* HIV negative\n* No intolerance to exogenous protein administration\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* At least 1 month since prior immunotherapy\n\nChemotherapy:\n\n* See Disease Characteristics\n* At least 1 month since prior chemotherapy\n\nEndocrine therapy:\n\n* Not specified\n\nRadiotherapy:\n\n* At least 1 month since prior radiotherapy\n\nSurgery:\n\n* Not specified"}, 'identificationModule': {'nctId': 'NCT00012051', 'briefTitle': "Chemotherapy and Peripheral Stem Cell Transplant With or Without Monoclonal Antibody Therapy in Treating Patients With Non-Hodgkin's Lymphoma", 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Randomised Phase III Study On The Effect Of The Chimeric Anti-CD20 Monoclonal Antibody (Mabthera) During Sequential Chemotherapy Followed By Autologous Stem Cell Transplantation In Patients With Relapse B-Cell Non-Hodgkin Lymphoma(HOVON 44 STUDY)', 'orgStudyIdInfo': {'id': 'CKTO-2000-06'}, 'secondaryIdInfos': [{'id': 'CDR0000068476', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}, {'id': 'HOVON-44'}, {'id': 'HOVON-44/CKVO-2000-06'}, {'id': 'EU-20042'}, {'id': 'ISRCTN95614846'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'filgrastim', 'type': 'BIOLOGICAL'}, {'name': 'rituximab', 'type': 'BIOLOGICAL'}, {'name': 'carmustine', 'type': 'DRUG'}, {'name': 'cisplatin', 'type': 'DRUG'}, {'name': 'cytarabine', 'type': 'DRUG'}, {'name': 'dexamethasone', 'type': 'DRUG'}, {'name': 'etoposide', 'type': 'DRUG'}, {'name': 'ifosfamide', 'type': 'DRUG'}, {'name': 'melphalan', 'type': 'DRUG'}, {'name': 'methotrexate', 'type': 'DRUG'}, {'name': 'bone marrow ablation with stem cell support', 'type': 'PROCEDURE'}, {'name': 'peripheral blood stem cell transplantation', 'type': 'PROCEDURE'}, {'name': 'radiation therapy', 'type': 'RADIATION'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B-3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'U.Z. Gasthuisberg', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '5211 NL', 'city': "'s-Hertogenbosch", 'country': 'Netherlands', 'facility': 'Jeroen Bosch Ziekenhuis', 'geoPoint': {'lat': 51.69917, 'lon': 5.30417}}, {'zip': '3816 CP', 'city': 'Amersfoort', 'country': 'Netherlands', 'facility': 'Meander Medisch Centrum', 'geoPoint': {'lat': 52.155, 'lon': 5.3875}}, {'zip': '1066 BE', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '1081HV', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Vrije Universiteit Medisch Centrum', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '1105 AZ', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Academisch Medisch Centrum at University of Amsterdam', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '7500 KA', 'city': 'Enschede', 'country': 'Netherlands', 'facility': 'Medisch Spectrum Twente', 'geoPoint': {'lat': 52.21833, 'lon': 6.89583}}, {'zip': '9713 EZ', 'city': 'Groningen', 'country': 'Netherlands', 'facility': 'University Medical Center Groningen', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'zip': '8934 AD', 'city': 'Leeuwarden', 'country': 'Netherlands', 'facility': 'Medisch Centrum Leeuwarden - Zuid', 'geoPoint': {'lat': 53.20271, 'lon': 5.80973}}, {'zip': '2300 CA', 'city': 'Leiden', 'country': 'Netherlands', 'facility': 'Leiden University Medical Center', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}, {'zip': '6202 AZ', 'city': 'Maastricht', 'country': 'Netherlands', 'facility': 'Academisch Ziekenhuis Maastricht', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}, {'zip': '3435 CM', 'city': 'Nieuwegein', 'country': 'Netherlands', 'facility': 'Sint Antonius Ziekenhuis', 'geoPoint': {'lat': 52.02917, 'lon': 5.08056}}, {'zip': 'NL-6500 HB', 'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'Universitair Medisch Centrum St. Radboud - Nijmegen', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'zip': '3008 AE', 'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Daniel Den Hoed Cancer Center at Erasmus Medical Center', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': '2545 CH', 'city': 'The Hague', 'country': 'Netherlands', 'facility': 'HagaZiekenhuis - Locatie Leyenburg', 'geoPoint': {'lat': 52.07667, 'lon': 4.29861}}, {'zip': '3584 CX', 'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'University Medical Center Utrecht', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}, {'zip': '8000 GK', 'city': 'Zwolle', 'country': 'Netherlands', 'facility': 'Isala Klinieken - locatie Sophia', 'geoPoint': {'lat': 52.5125, 'lon': 6.09444}}], 'overallOfficials': [{'name': 'Edo Vellenga, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University Medical Center Groningen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Commissie Voor Klinisch Toegepast Onderzoek', 'class': 'OTHER'}}}}