Study of the Combination of Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Mantle Cell Lymphoma
Overview[ - collapse ][ - ]
| Purpose | This is a randomized, open-label, multicentre, prospective study to compare the efficacy and safety of the combination of VcR-CAP to that of R-CHOP in patients who have newly diagnosed mantle cell lymphoma grade II, III or IV and who are ineligible to undergo bone marrow transplantation. |
|---|---|
| Condition | Mantle Cell Lymphoma |
| Intervention | Drug: Rituximab Drug: Cyclophosphamide Drug: Doxorubicin Drug: VELCADE Drug: Prednisone Drug: Vincristine |
| Phase | Phase 3 |
| Sponsor | Millennium Pharmaceuticals, Inc. |
| Responsible Party | Millennium Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier | NCT00722137 |
| First Received | July 23, 2008 |
| Last Updated | December 10, 2013 |
| Last verified | December 2013 |
Tracking Information[ + expand ][ + ]
| First Received Date | July 23, 2008 |
|---|---|
| Last Updated Date | December 10, 2013 |
| Start Date | May 2008 |
| Estimated Primary Completion Date | January 2014 |
| Current Primary Outcome Measures | Progression free survival [Time Frame: 18-25 months] [Designated as safety issue: No] |
| Current Secondary Outcome Measures | Overall response rate [Time Frame: 18-25 months] [Designated as safety issue: No] |
Descriptive Information[ + expand ][ + ]
| Brief Title | Study of the Combination of Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Mantle Cell Lymphoma |
|---|---|
| Official Title | A Randomized, Open-Label, Multicentre Phase 3 Study of the Combination of Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Mantle Cell Lymphoma Who Are Not Eligible for a Bone Marrow Transplant |
| Brief Summary | This is a randomized, open-label, multicentre, prospective study to compare the efficacy and safety of the combination of VcR-CAP to that of R-CHOP in patients who have newly diagnosed mantle cell lymphoma grade II, III or IV and who are ineligible to undergo bone marrow transplantation. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 3 |
| Study Design | Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Mantle Cell Lymphoma |
| Intervention | Drug: Rituximab Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles. Drug: Cyclophosphamide Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles Drug: Doxorubicin Intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles Drug: VELCADE VELCADE intravenous on Days 1,4,8, and 11of a 21 day (3 week) cycle for 6 cycles Drug: Prednisone Prednisone per overall survival on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles Drug: Vincristine Vincristine intravenous on Day 1of a 21 day (3 week) cycle for 6 cycles |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Active, not recruiting |
|---|---|
| Estimated Enrollment | 486 |
| Estimated Completion Date | January 2014 |
| Estimated Primary Completion Date | June 2012 |
| Eligibility Criteria | Inclusion Criteria: - Male or female patients 18 years or older. - Diagnosis of mantle cell lymphoma (Stage II, III or IV). - At least 1 measurable site of disease. - No prior therapies for mantle cell lymphoma. - Not eligible for bone marrow transplantation. Exclusion Criteria: - Prior treatment with VELCADE. - Prior anti-neoplastic (including unconjugated therapeutic antibodies), experimental or radiation therapy, radioimmunoconjugates or toxin immunoconjugates for the treatment of mantle cell lymphoma. - Major surgery. - Active systemic infection requiring treatment and patients with known diagnosis of HIV or active Hepatitis B. - Peripheral neuropathy or neuropathic pain of Grade 2 or worse. - Diagnosed or treated for a malignancy other than mantle cell lymphoma (MCL) within 1 year of randomization, or who were previously diagnosed with a malignancy other than MCL and have any radiographic or biochemical marker evidence of malignancy. |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United States, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Germany, Hungary, India, Israel, Italy, Malaysia, Morocco, Philippines, Poland, Portugal, Romania, Russian Federation, Singapore, South Africa, Spain, Taiwan, Thailand, Tunisia, Turkey, Ukraine |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00722137 |
|---|---|
| Other Study ID Numbers | 26866138-LYM-3002 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | Millennium Pharmaceuticals, Inc. |
| Study Sponsor | Millennium Pharmaceuticals, Inc. |
| Collaborators | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
| Investigators | Study Director: Medical Monitor Millennium Pharmaceuticals, Inc. |
| Verification Date | December 2013 |
Locations[ + expand ][ + ]
| St. Francis Hosptial and Medical Center | Hartford, Connecticut, United States, 06105 |
|---|---|
| Center for Cancer Care at Goshen Hospital | Goshen, Indiana, United States, 46526 |
| Sinai Hospital | Baltimore, Maryland, United States, 21215 |
| Capitol Comp. Cancer Center | Jefferson City, Missouri, United States, 65109 |
| Nebraska Cancer Specialists | Omaha, Nebraska, United States, 68114 |
| Hematology-Oncology Associates of Northern NJ | Morristown, New Jersey, United States, 07960 |
| Legacy Pharma Research | Bismarck, North Dakota, United States, 58501 |
| Division of Hematology and Oncology Vanderbilt University | Nashville, Tennessee, United States, 37232 |
| Cancer Outreach Associates, PC | Abingdon, Virginia, United States, 24211 |
| St.Johanns Spital/Landeskrankenhaus Salzburg | Salzburg, Austria |
| Allgemeines Krankenhaus der Stadt Wien | Wien, Austria |
| AZ Stuivenberg Oncologie/ Hematologie | Antwerpen, Belgium |
| AZ St Jan AV | Brugge, Belgium |
| UZ Brussel Department Medical Oncology | Brussels, Belgium |
| UZA Hematologie, 1e verdiep | Edegem, Belgium |
| Universitair Ziekenhuis Gent - UZ GENT, Hematologie, 9K12IE 9de verdiep- polikliniek Hematologie | Gent, Belgium |
| UZ Leuven Gasthuisberg Hematologie | Leuven, Belgium |
| C.H.R. Citadelle | Liege, Belgium |
| Centre Hospitalier Universitaire | Liege, Belgium |
| Ucl de Mont-Godinne | Yvoir, Belgium |
| Centro de Hematologia E Hemoterapia - Unicamp | Campinas, Brazil |
| Fundacao Hospital Amaral Carvalho | Jau, Brazil |
| Hospital Sao Lucas Puc-Rs | Porto Alegre, Brazil |
| Hospital Nossa Senhora da Conceicao | Porto Alegre, Brazil |
| Inca - Instituto Nacional Do Cancêr | Rio de Janeiro, Brazil |
| Hospital das Clínicas da Faculdade de Medicina da USP | Sao Paulo, Brazil |
| Hospital Alemao Oswaldo Cruz | Sao Paulo, Brazil |
| Fundacao Pio XII - Hospital de Cancer de Barretos | Sao Paulo, Brazil |
| Centro de Estudos de Hematologia E Oncologia Da Fmabc | Sao Paulo, Brazil |
| Santa Casa de Misericórida de São Paulo | Sao Paulo, Brazil |
| Hospital Ac Camargo | Sao Paulo, Brazil |
| Cross Cancer Institute | Edmonton, Alberta, Canada |
| University Health Network, Princess Margaret Hospital | Toronto, Ontario, Canada |
| Hospital Clinico Universidad Catolica de Chile | Santiago, Chile |
| Instituto Nacional Del Cancer | Santiago, Chile |
| Hospital Del Salvador | Santiago, Chile |
| Sun Yat-sen University Cancer Center | Guangzhou, Guangdong, China |
| West China Hospital, Sichuan University | Chengdu, Sichuan, China |
| Zhejiang University First Hospital | Hangzhou, Zhejiang, China |
| Peking University Third Hospital | Beijing, China |
| Cancer Institute & Cancer Hospital, CAMS&PUMC | Beijing, China |
| Beijing Cancer Hospital | Beijing, China |
| Ruijin Hospital | Shanghai, China |
| Cancer hospital, Fudan University | Shanghai, China |
| Tianjin Medical University Cancer Hospital and Institute | Tianjin, China |
| Clinica Reina Sofia | Bogota, Colombia |
| Hospital Universitario San Vicente de Paul | Medellin, Colombia |
| Hospital Pablo Tobon Uribe | Medellin, Colombia |
| Interni hematoonkoligicka klinika | Brno, Czech Republic |
| Interni klinika - Oddeleni klin. hematologie Fakultni nemocnice Hradec Kralove | Hradec Kralove, Czech Republic |
| Oddeleni klinicke hematologie, Fakultni nemocnice Kralovske Vinohrady | Praha, Czech Republic |
| Vivantes Klinikum Spandau Klinik für Innere Medizin - Hämatologie, Onkologie und Gastroenterologie | Berlin, Germany |
| Vivantes Klinikum Neukölln Klinik für Innere Medizin Hämatologie und Onkologie | Berlin, Germany |
| Städt. Kliniken Frankfurt-Hoechst Med. Klinik II - Hämatologie und Onkologie | Frankfurt, Germany |
| Tumorklinik SANAFONTIS Alpine GmbH | Freiburg, Germany |
| Wilhelm-Anton-Hospital Goch gGmbH Klinik für Hämatologie und internistische Onkologie | Goch, Germany |
| Klinikum Lippe-Lemgo Med. Klinik II - Hämatologie und Onkologie | Lemgo, Germany |
| Johannes-Gutenberg-Universität Mainz III. Med. Klinik | Mainz, Germany |
| Mutterhaus der Borromäerinnen Med. Klinik I | Trier, Germany |
| Schwarzwald-Baar-Kliniken Innere Med. II | Villingen, Germany |
| Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum, III. sz. Belgyogyaszati Klinika | Debrecen, Hungary |
| Petz Aladár Kórház, II. Belgyógyászat | Győr, Hungary |
| Kaposi Mor Megyei Korhaz, Belgyogyaszat | Kaposvar, Hungary |
| Apollo Hospital and Research Foundation, Apollo Hospitals | Hyderabad 500033, Andhra Pradesh, India |
| Sir Ganga Ram Hospital | New Delhi- 110060, Delhi, India |
| Kidwai Memorial Institute of Oncology | Bangalore 560 029, Karnataka, India |
| Regional Cancer Centre, Medical Oncology | Thiruvananthapuram, Kerala-695011, India |
| Jehangir Hospital | Pune-411002, Maharashtra, India |
| Apollo Speciality Hospital, Chennai | Chennai-600035, Tamil Nadu, India |
| Netaji Subash Chanda Bose Cancer Research Institute | Kolkata- 700016, West Bengal, India |
| Rambam Medical Center-Hematology department | Haifa, Israel |
| Hadassah Medical Center - Hematology department | Jerusalem, Israel |
| Rabin Medical Center, Beilinson Campus | Petach Tiqva, Israel |
| Sheba Medical Center | Ramat-Gan, Israel |
| Kaplan Medical Center - Hematology Institute | Rechovot, Israel |
| Azienda Ospedaliera Universitaria di Bologna Policlinico S.Orsola-Malpighi Dipartimento di Ematologia e Scienze Oncologiche "L. e A. Seragnoli" | Bologna, Italy |
| Spedali Civili di Brescia | Brescia, Italy |
| Dipartimento di Oncologia ed Ematologia Università di Modena e Reggio Emilia | Modena, Italy |
| AZIENDA OSPEDALIERA UNIVERSITARIA POLICLINICO TOR VERGATA DIPARTIMENTO DI MEDICINA U.O.C. Ematologia | Roma, Italy |
| Azienda Ospedaliera San Giovanni Battista "Molinette" Struttura Complessa Ematologia 2 | Torino, Italy |
| University Malaya Medical Centre | Kuala Lumpur, Malaysia |
| Gleneagles Medical Centre | Pulau Pinang, Malaysia |
| Hopital Du 20 Aout 1953 | Casablanca, Morocco |
| Centre D'oncologie Al Azhar | Rabat, Morocco |
| Institut National D'oncologie | Rabat, Morocco |
| St Lukes Medical Center | Quezon City, Philippines |
| National Kidney and Transplant Institute | Quezon City, Philippines |
| Szpital Morski im. PCK w Gdyni Gdynskie Centrum Onkologii Oddzial Chemioterapii | Gdynia, Poland |
| Klinika Hematologii Uniwersytetu Medycznego w Lodzi | Lodz, Poland |
| "Katedra i Klinika Hematologii i Chorob Rozrostowych Ukladu Krwiotworczego | Poznan, Poland |
| Klinika Hematologii Nowotworow Krwi i Transplantacji Szpiku Akademii Medycznej we Wroclawiu | Wroclaw, Poland |
| Hospital Sao Marcos | Braga, Portugal |
| Hospitais da Universidade de Coimbra | Coimbra, Portugal |
| Hospital de Santa Maria | Lisboa, Portugal |
| Instituto Portugues de Oncologia | Porto, Portugal |
| Spitalul Judetean de Urgenta "Dr. Constantin Opris", Hematologie | Baia Mare, Romania |
| Spitalul Clinic Universitar de Urgenta Bucuresti, Hematologie | Bucuresti, Romania |
| Institutul Clinic Fundeni, Hematologie | Bucuresti, Romania |
| Spitalul Clinic Coltea, Clinica Hematologie | Bucuresti, Romania |
| Spitalul Clinic Judetean de Urgenta "Sf. Spiridon" Iasi, Oncologie Medicala | Iasi, Romania |
| Arkhangelsk Regional Clinical Hospital | Arkhangelsk, Russian Federation |
| Belgorod Regional Oncology Center | Belgorod, Russian Federation |
| Chelyabinsk Regional Oncology Center | Chelyabinsk, Russian Federation |
| Sverdlovsk Regional Oncology Dispensary | Ekaterinburg, Russian Federation |
| 1st Republican Clinical Hospital of Udmurtia | Izhevsk, Russian Federation |
| Hematology Scientific Center | Moscow, Russian Federation |
| S.P. Botkin Moscow City Clinical Hospital | Moscow, Russian Federation |
| Cancer Research Center RAMS - N.N. Blokhin - Academy of Medical Science | Moscow, Russian Federation |
| Moscow Regional Clinical Research Institute | Moscow, Russian Federation |
| Nizhniy Novgorod Region Clinical Hospital | Nizhniy Novgorod, Russian Federation |
| Medical Scientific Radiology - Center | Obninsk, Russian Federation |
| Omsk Regional Oncology Dispensary | Omsk, Russian Federation |
| Medical Sanitary Unit # 1 | Perm, Russian Federation |
| Republikan Hospital named after V.A/ Baranov | Petrozavodsk, Russian Federation |
| Rostov Research Institute of Oncology | Rostov-on-Don, Russian Federation |
| City Clinical Oncology Dispensary | St Petersburg, Russian Federation |
| Pavlov State Medical Univercity | St-Petersburg, Russian Federation |
| Central Res. Inst. of Roentgen-Radiology | St-Petersburg, Russian Federation |
| St.-Petersburg Clinical Research Institute of Hematology and Transfusiology | St. Petersburg, Russian Federation |
| Leningrad Region Clinical Hospital | St. Petersburg, Russian Federation |
| Singapore General Hospital - Hematology | Singapore, Singapore |
| National Cancer Centre | Singapore, Singapore |
| University of the Witwatersrand Oncology | Johannesburg, Gauteng, South Africa |
| Chris Hani Baragwanath Hospital | Johannesburg, Gauteng, South Africa |
| Medical Oncology Center of Rosebank | Johannesburg, Gauteng, South Africa |
| Pretoria Academic Hospital-Dr. Savage Road, 3rd Floor Radiotherapy Building, Prinshof | Pretoria, Gauteng, South Africa |
| Dr AI Pirjol & Dr WM Szpak Inc. | Durban, Kwazulu Natal, South Africa |
| Hospital Universitario Germans Trias i Pujol | Badalona, Barcelona, Spain |
| Hospital Clinic I Provincial de Barcelona | Barcelona, Spain |
| Hospital de la Princesa | Madrid, Spain |
| Hospital Universitario 12 de Octubre | Madrid, Spain |
| Hospital Clinico Universitario Salamanca | Salamanca, Spain |
| Chang Gung Memorial Hospital, Linkou | Tao-Yuan, Taiwan |
| Ramathibodi Hospital | Bangkok, Thailand |
| Siriraj Hospital-Hematology Unit | Bangkok, Thailand |
| King Chulalongkorn Memorial Hospital | Bangkok, Thailand |
| Maharaj Nakorn Chiang Mai hospital - Faculty of Medicine | Chiang Mai, Thailand |
| Hôpital Farhat Hached | Sousse, Tunisia |
| Institut Salah Azaiz | Tunis, Tunisia |
| Hôpital Aziza Othmana | Tunis, Tunisia |
| Centre National de Greffe de Moelle osseuse | Tunis, Tunisia |
| Hacettepe University Medical Faculty | Ankara, Turkey |
| Dokuz Eylul University Med. Fac. | Izmir, Turkey |
| Cherkassy Regional Oncology Center, Dept. of Hematology | Cherkassy, Ukraine |
| Dnepropetrovsk City Clinical Hospital #4, Regional Hematology Center | Dnepropetrovsk, Ukraine |
| Institute of Urgent and Recovery Surgery named after V.K.Gusaka of AMS of Ukraine, Haematology Dept. | Donetsk, Ukraine |
| Khmelnitskiy Regional Hospital, Hematology Department | Khmelnitsky, Ukraine |
| National Cancer Institute, Department of chemotherapy of hemoblastosis | Kiev, Ukraine |
| Institute of Blood Pathology and Transfusion Medicine, Lviv Clinical Hospital #5, Hematology Dept. | Lviv, Ukraine |
| Crimean Republic Clinical Oncology Dispensary, Haematology Department | Simferopol, Ukraine |