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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00722137
First received: July 23, 2008
Last updated: December 10, 2013
Last verified: December 2013
  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 Intervention Phase
Mantle Cell Lymphoma
Drug: Rituximab
Drug: Cyclophosphamide
Drug: Doxorubicin
Drug: VELCADE
Drug: Prednisone
Drug: Vincristine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Millennium Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Progression free survival [ Time Frame: 18-25 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall response rate [ Time Frame: 18-25 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 486
Study Start Date: May 2008
Estimated Study Completion Date: January 2014
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VcR-CAP
Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone
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
Active Comparator: R-CHOP
Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
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: 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00722137

  Hide Study Locations
Locations
United States, Connecticut
St. Francis Hosptial and Medical Center
Hartford, Connecticut, United States, 06105
United States, Indiana
Center for Cancer Care at Goshen Hospital
Goshen, Indiana, United States, 46526
United States, Maryland
Sinai Hospital
Baltimore, Maryland, United States, 21215
United States, Missouri
Capitol Comp. Cancer Center
Jefferson City, Missouri, United States, 65109
United States, Nebraska
Nebraska Cancer Specialists
Omaha, Nebraska, United States, 68114
United States, New Jersey
Hematology-Oncology Associates of Northern NJ
Morristown, New Jersey, United States, 07960
United States, North Dakota
Legacy Pharma Research
Bismarck, North Dakota, United States, 58501
United States, Tennessee
Division of Hematology and Oncology Vanderbilt University
Nashville, Tennessee, United States, 37232
United States, Virginia
Cancer Outreach Associates, PC
Abingdon, Virginia, United States, 24211
Austria
St.Johanns Spital/Landeskrankenhaus Salzburg
Salzburg, Austria
Allgemeines Krankenhaus der Stadt Wien
Wien, Austria
Belgium
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
Brazil
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
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada
Canada, Ontario
University Health Network, Princess Margaret Hospital
Toronto, Ontario, Canada
Chile
Hospital Del Salvador
Santiago, Chile
Instituto Nacional Del Cancer
Santiago, Chile
Hospital Clinico Universidad Catolica de Chile
Santiago, Chile
China, Guangdong
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
China, Sichuan
West China Hospital, Sichuan University
Chengdu, Sichuan, China
China, Zhejiang
Zhejiang University First Hospital
Hangzhou, Zhejiang, China
China
Peking University Third Hospital
Beijing, China
Cancer Institute & Cancer Hospital, CAMS&PUMC
Beijing, China
Beijing Cancer Hospital
Beijing, China
Cancer hospital, Fudan University
Shanghai, China
Ruijin Hospital
Shanghai, China
Tianjin Medical University Cancer Hospital and Institute
Tianjin, China
Colombia
Clinica Reina Sofia
Bogota, Colombia
Hospital Universitario San Vicente de Paul
Medellin, Colombia
Hospital Pablo Tobon Uribe
Medellin, Colombia
Czech Republic
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
Germany
Vivantes Klinikum Neukölln Klinik für Innere Medizin Hämatologie und Onkologie
Berlin, Germany
Vivantes Klinikum Spandau Klinik für Innere Medizin - Hämatologie, Onkologie und Gastroenterologie
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
Hungary
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
India
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
Israel
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
Italy
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
Malaysia
University Malaya Medical Centre
Kuala Lumpur, Malaysia
Gleneagles Medical Centre
Pulau Pinang, Malaysia
Morocco
Hopital Du 20 Aout 1953
Casablanca, Morocco
Centre D'oncologie Al Azhar
Rabat, Morocco
Institut National D'oncologie
Rabat, Morocco
Philippines
St Lukes Medical Center
Quezon City, Philippines
National Kidney and Transplant Institute
Quezon City, Philippines
Poland
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
Portugal
Hospital Sao Marcos
Braga, Portugal
Hospitais da Universidade de Coimbra
Coimbra, Portugal
Hospital de Santa Maria
Lisboa, Portugal
Instituto Portugues de Oncologia
Porto, Portugal
Romania
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
Russian Federation
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
Moscow Regional Clinical Research Institute
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
Hematology Scientific Center
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
National Cancer Centre
Singapore, Singapore
Singapore General Hospital - Hematology
Singapore, Singapore
South Africa
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
Spain
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
Taiwan
Chang Gung Memorial Hospital, Linkou
Tao-Yuan, Taiwan
Thailand
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
Tunisia
Hôpital Farhat Hached
Sousse, Tunisia
Institut Salah Azaiz
Tunis, Tunisia
Hôpital Aziza Othmana
Tunis, Tunisia
Centre National de Greffe de Moelle osseuse
Tunis, Tunisia
Turkey
Hacettepe University Medical Faculty
Ankara, Turkey
Dokuz Eylul University Med. Fac.
Izmir, Turkey
Ukraine
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
Sponsors and Collaborators
Millennium Pharmaceuticals, Inc.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director: Medical Monitor Millennium Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00722137     History of Changes
Other Study ID Numbers: 26866138-LYM-3002
Study First Received: July 23, 2008
Last Updated: December 10, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lymphoma, Mantle-Cell
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Rituximab
Bortezomib
Liposomal doxorubicin
Vincristine
Doxorubicin
Prednisone
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents

ClinicalTrials.gov processed this record on October 19, 2014