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

NCT00722137 | Completed Phase 3 Results FDA Drug

• 5 other identifiers: 26866138-LYM-300226866138-LYM-3002CTIL2007-005669-370970313683U1111-1195-3827
• Study Type: interventional
• Target: 487
• Locations: 28 countries
• Sites: 148

Brief Summary

This is a randomized, open-label, multicenter, prospective study to compare the efficacy and safety of the combination of VcR-CAP to that of R-CHOP in participants who have newly diagnosed mantle cell lymphoma grade II, III or IV and who are ineligible to undergo bone marrow transplantation.

Conditions

Mantle Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  PFS was defined as the interval between the date of randomization and the date of progressive disease (PD) or death, whichever occurred first. PD was based on the assessment of an Independent Review Committee.

  Median duration of follow-up of 40 months

Secondary Outcomes (10)

• Time to Progression (TTP)

  Median duration of follow-up of 40 months

• Duration of Response

  Median duration of follow-up of 40 months

• Time to Next Anti-lymphoma Treatment (TTNT)

  : Median duration of follow-up of 40 months

• Treatment-free Interval (TFI)

  Median duration of follow-up of 40 months

• Overall Response Rate (ORR)

  Median duration of follow-up of 40 months

Study Arms (2)

R-CHOP

ACTIVE COMPARATOR

Rituximab 375 mg/m\^2, Cyclophosphamide 750 mg/m\^2, Doxorubicin 50 mg/m\^2, Vincristine 1.4 mg/m\^2, and Prednisone 100 mg/m\^2

Drug: Rituximab 375 mg/m^2; Drug: Cyclophosphamide 750 mg/m^2; Drug: Doxorubicin 50 mg/m^2; Drug: Prednisone 100 mg/m^2; Drug: Vincristine 1.4 mg/m^2

VcR-CAP

EXPERIMENTAL

Rituximab 375 mg/m\^2, Cyclophosphamide 750 mg/m\^2, Doxorubicin 50 mg/m\^2, VELCADE 1.3 mg/m\^2, and Prednisone 100 mg/m\^2

Drug: Rituximab 375 mg/m^2; Drug: Cyclophosphamide 750 mg/m^2; Drug: Doxorubicin 50 mg/m^2; Drug: VELCADE 1.3 mg/m^2; Drug: Prednisone 100 mg/m^2

Interventions

Rituximab 375 mg/m^2 DRUG

Intravenous rituximab 375 mg/m\^2 on Day 1 of a 21-day (3 week) cycle for 6 cycles.

R-CHOP; VcR-CAP

Cyclophosphamide 750 mg/m^2 DRUG

Intravenous cyclophosphamide 750 mg/m\^2 on Day 1 of a 21-day (3 week) cycle for 6 cycles

R-CHOP; VcR-CAP

Doxorubicin 50 mg/m^2 DRUG

Intravenous doxorubicin 50 mg/m\^2 on Day 1 of a 21-day (3 week) cycle for 6 cycles

R-CHOP; VcR-CAP

VELCADE 1.3 mg/m^2 DRUG

Intravenous VELCADE 1.3 mg/m\^2 on Days 1,4,8, and 11of a 21-day (3 week) cycle for 6 cycles

VcR-CAP

Prednisone 100 mg/m^2 DRUG

Oral prednisone 100 mg/m\^2 on Day 1 to Day 5 of a 21-day (3 week) cycle for 6 cycles

R-CHOP; VcR-CAP

Vincristine 1.4 mg/m^2 DRUG

Intravenous vincristine 1.4 mg/m\^2 on Day 1of a 21-day (3 week) cycle for 6 cycles. Maximum of 2 mg. Participants could receive 8 cycles if a response was initially documented at the Cycle 6 assessment.

R-CHOP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients 18 years or older (the patient must be at least the legal age limit to be able to give informed consent within the jurisdiction the study is taking place)
• Diagnosis of mantle cell lymphoma MCL (Stage II, III or IV) as evidenced by lymph node histology and either expression of cyclin D1 (in association with CD20 and CD5) or evidence of t(11;14) translocation, such as by cytogenetics, fluorescent in situ hybridization (FISH) or polymerase chain reaction (PCR). Patients with a diagnosis of Stage I MCL will not be permitted to enter study.
• \- Paraffin embedded biopsy tissue block (preferably of lymph node origin) must be sent to the central laboratory for confirmation of MCL diagnosis prior to randomization. In China, a paraffin embedded lymph node biopsy tissue block must be sent for central confirmation of sample adequacy, prior to randomization
• At least 1 measurable site of disease
• No prior therapies for MCL
• Not eligible for bone marrow transplantation as assessed by the treating physician (e.g., age or the presence of co-morbid conditions that may have a negative impact on the tolerability to transplantation).
• Eastern Cooperative Oncology Group ECOG status ≤2
• Absolute neutrophil count (ANC) ≥1500 cells/µL,
• Platelets ≥100,000 cells/µL or ≥75,000 cells/µL if thrombocytopenia is considered by the investigator to be secondary to MCL (e.g., due to bone marrow infiltration or sequestration from splenomegaly).
• Alanine transaminase ≤3 x upper limit of normal (ULN)
• Aspartate transaminase ≤3 x ULN
• Total bilirubin ≤1.5 x ULN,
• Calculated creatinine clearance ≥20 mL/min.
• Female patients must be post menopausal for at least 1 year (must not have had a natural menses for at least 12 months), surgically sterile, or practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) and have a negative serum βHCG or urine pregnancy test at screening. They must also be prepared to continue birth control measures for at least 6 months after terminating treatment.
• Male patients must agree to use an acceptable method of contraception (for themselves or female partners as listed above) for the duration of the study.

You may not qualify if:

• Prior treatment with VELCADE
• Prior antineoplastic (including unconjugated therapeutic antibodies), experimental or radiation therapy, radioimmunoconjugates or toxin immunoconjugates for the treatment of MCL. In the event that a patient has received doxorubicin for the treatment of any condition, other than MCL, the maximum dose and exposure received prior to entry into this study should not exceed 150 mg/m2.
• \- short course (maximum of 10 days, not exceeding 100 mg/day) prednisone or equivalent steroids are allowed to treat symptoms in patients with advanced disease who enter the screening phase and are waiting to be randomized.
• Major surgery (at the discretion of the treating physician and in consultation with the sponsor's medical monitor) within 2 weeks before randomization
• Peripheral neuropathy or neuropathic pain of Grade 2 or worse (as per the investigators assessment)
• Diagnosed or treated for a malignancy other than 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. Patients with completely resected basal cell carcinoma, squamous cell carcinoma of the skin, or in situ malignancy are not excluded.
• Active systemic infection requiring treatment and patients with known diagnosis of human immunodeficiency virus HIV or active hepatitis B (carriers of hepatitis B are permitted to enter study)
• History of allergic reaction attributable to compounds containing boron, mannitol, or hydroxybenzoates
• Known anaphylaxis or immunoglobulin E (IgE)-mediated hypersensitivity to murine proteins or to any component of rituximab including polysorbate 80 and sodium citrate dihydrate
• Female or male patients of child-bearing potential who will not use adequate contraception during the course of the study.
• Serious medical (e.g., pericardial disease, cardiac failure \[New York Heart Association; NYHA Class III or IV, Attachment 12 or left ventricular ejection fraction; LVEF \<50%\], active peptic ulceration, uncontrolled diabetes mellitus, or acute diffuse infiltrative pulmonary disease), or psychiatric illness likely to interfere with participation in this clinical study
• Concurrent treatment with another investigational agent.

Sponsors & Collaborators

• Millennium Pharmaceuticals, Inc.: lead
• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: collaborator

Study Sites (150)

St. Francis Hosptial and Medical Center

Hartford, Connecticut, 06105, United States

Location

Center for Cancer Care at Goshen Hospital

Goshen, Indiana, 46526, United States

Location

Sinai Hospital

Baltimore, Maryland, 21215, United States

Location

Capitol Comp. Cancer Center

Jefferson City, Missouri, 65109, United States

Location

Nebraska Cancer Specialists

Omaha, Nebraska, 68114, United States

Location

Hematology-Oncology Associates of Northern NJ

Morristown, New Jersey, 07960, United States

Location

Legacy Pharma Research

Bismarck, North Dakota, 58501, United States

Location

Division of Hematology and Oncology Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

Cancer Outreach Associates, PC

Abingdon, Virginia, 24211, United States

Location

St.Johanns Spital/Landeskrankenhaus Salzburg

Salzburg, Austria

Location

Allgemeines Krankenhaus der Stadt Wien

Vienna, Austria

Location

AZ Stuivenberg Oncologie/ Hematologie

Antwerp, Belgium

Location

AZ St Jan AV

Bruges, Belgium

Location

UZ Brussel Department Medical Oncology

Brussels, Belgium

Location

UZA Hematologie, 1e verdiep

Edegem, Belgium

Location

Universitair Ziekenhuis Gent - UZ GENT, Hematologie, 9K12IE 9de verdiep- polikliniek Hematologie

Ghent, Belgium

Location

UZ Leuven Gasthuisberg Hematologie

Leuven, Belgium

Location

C.H.R. Citadelle

Liège, Belgium

Location

Centre Hospitalier Universitaire

Liège, Belgium

Location

Ucl de Mont-Godinne

Yvoir, Belgium

Location

Centro de Hematologia E Hemoterapia - Unicamp

Campinas, Brazil

Location

Fundacao Hospital Amaral Carvalho

Jaú, Brazil

Location

Hospital Nossa Senhora da Conceicao

Porto Alegre, Brazil

Location

Hospital Sao Lucas Puc-Rs

Porto Alegre, Brazil

Location

Inca - Instituto Nacional Do Cancêr

Rio de Janeiro, Brazil

Location

Centro de Estudos de Hematologia E Oncologia Da Fmabc

São Paulo, Brazil

Location

Fundacao Pio XII - Hospital de Cancer de Barretos

São Paulo, Brazil

Location

Hospital Ac Camargo

São Paulo, Brazil

Location

Hospital Alemao Oswaldo Cruz

São Paulo, Brazil

Location

Hospital das Clínicas da Faculdade de Medicina da USP

São Paulo, Brazil

Location

Santa Casa de Misericórida de São Paulo

São Paulo, Brazil

Location

Cross Cancer Institute

Edmonton, Alberta, Canada

Location

University Health Network, Princess Margaret Hospital

Toronto, Ontario, Canada

Location

Hospital Clinico Universidad Catolica de Chile

Santiago, Chile

Location

Hospital Del Salvador

Santiago, Chile

Location

Instituto Nacional Del Cancer

Santiago, Chile

Location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Location

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Location

Zhejiang University First Hospital

Hangzhou, Zhejiang, China

Location

Beijing Cancer Hospital

Beijing, China

Location

Cancer Institute & Cancer Hospital, CAMS&PUMC

Beijing, China

Location

Peking University Third Hospital

Beijing, China

Location

Cancer hospital, Fudan University

Shanghai, China

Location

Ruijin Hospital

Shanghai, China

Location

Tianjin Medical University Cancer Hospital and Institute

Tianjin, China

Location

Clinica Reina Sofia

Bogotá, Colombia

Location

Hospital Pablo Tobon Uribe

Medellín, Colombia

Location

Hospital Universitario San Vicente de Paul

Medellín, Colombia

Location

Interni hematoonkoligicka klinika

Brno, Czechia

Location

Interni klinika - Oddeleni klin. hematologie Fakultni nemocnice Hradec Kralove

Hradec Králové, Czechia

Location

Oddeleni klinicke hematologie, Fakultni nemocnice Kralovske Vinohrady

Prague, Czechia

Location

Vivantes Klinikum Neukölln Klinik für Innere Medizin Hämatologie und Onkologie

Berlin, Germany

Location

Vivantes Klinikum Spandau Klinik für Innere Medizin - Hämatologie, Onkologie und Gastroenterologie

Berlin, Germany

Location

Städt. Kliniken Frankfurt-Hoechst Med. Klinik II - Hämatologie und Onkologie

Frankfurt, Germany

Location

Tumorklinik SANAFONTIS Alpine GmbH

Freiburg im Breisgau, Germany

Location

Wilhelm-Anton-Hospital Goch gGmbH Klinik für Hämatologie und internistische Onkologie

Goch, Germany

Location

Klinikum Lippe-Lemgo Med. Klinik II - Hämatologie und Onkologie

Lemgo, Germany

Location

Johannes-Gutenberg-Universität Mainz III. Med. Klinik

Mainz, Germany

Location

Mutterhaus der Borromäerinnen Med. Klinik I

Trier, Germany

Location

Schwarzwald-Baar-Kliniken Innere Med. II

Villingen, Germany

Location

Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum, III. sz. Belgyogyaszati Klinika

Debrecen, Hungary

Location

Petz Aladár Kórház, II. Belgyógyászat

Győr, Hungary

Location

Kaposi Mor Megyei Korhaz, Belgyogyaszat

Kaposvár, Hungary

Location

Apollo Hospital and Research Foundation, Apollo Hospitals

Hyderabad 500033, Andhra Pradesh, India

Location

Kidwai Memorial Institute of Oncology

Bangalore 560 029, Karnataka, India

Location

Regional Cancer Centre, Medical Oncology

Thiruvananthapuram, Kerala-695011, India

Location

Jehangir Hospital

Pune-411002, Maharashtra, India

Location

Sir Ganga Ram Hospital

New Delhi- 110060, National Capital Territory of Delhi, India

Location

Apollo Speciality Hospital, Chennai

Chennai-600035, Tamil Nadu, India

Location

Netaji Subash Chanda Bose Cancer Research Institute

Kolkata- 700016, West Bengal, India

Location

Rambam Medical Center-Hematology department

Haifa, Israel

Location

Hadassah Medical Center - Hematology department

Jerusalem, Israel

Location

Rabin Medical Center, Beilinson Campus

Petach Tiqva, Israel

Location

Sheba Medical Center

Ramat Gan, Israel

Location

Kaplan Medical Center - Hematology Institute

Rehovot, Israel

Location

Azienda Ospedaliera Universitaria di Bologna Policlinico S.Orsola-Malpighi Dipartimento di Ematologia e Scienze Oncologiche "L. e A. Seragnoli"

Bologna, Italy

Location

Spedali Civili di Brescia

Brescia, Italy

Location

Dipartimento di Oncologia ed Ematologia Università di Modena e Reggio Emilia

Modena, Italy

Location

AZIENDA OSPEDALIERA UNIVERSITARIA POLICLINICO TOR VERGATA DIPARTIMENTO DI MEDICINA U.O.C. Ematologia

Roma, Italy

Location

Azienda Ospedaliera San Giovanni Battista "Molinette" Struttura Complessa Ematologia 2

Torino, Italy

Location

University Malaya Medical Centre

Kuala Lumpur, Malaysia

Location

Gleneagles Medical Centre

Pulau Pinang, Malaysia

Location

Hopital Du 20 Aout 1953

Casablanca, Morocco

Location

Centre D'oncologie Al Azhar

Rabat, Morocco

Location

Institut National D'oncologie

Rabat, Morocco

Location

National Kidney and Transplant Institute

Quezon City, Philippines

Location

St Lukes Medical Center

Quezon City, Philippines

Location

Szpital Morski im. PCK w Gdyni Gdynskie Centrum Onkologii Oddzial Chemioterapii

Gdynia, Poland

Location

Klinika Hematologii Uniwersytetu Medycznego w Lodzi

Lodz, Poland

Location

"Katedra i Klinika Hematologii i Chorob Rozrostowych Ukladu Krwiotworczego

Poznan, Poland

Location

Klinika Hematologii Nowotworow Krwi i Transplantacji Szpiku Akademii Medycznej we Wroclawiu

Wroclaw, Poland

Location

Hospital Sao Marcos

Braga, Portugal

Location

Hospitais da Universidade de Coimbra

Coimbra, Portugal

Location

Hospital de Santa Maria

Lisbon, Portugal

Location

Instituto Portugues de Oncologia

Porto, Portugal

Location

Spitalul Judetean de Urgenta "Dr. Constantin Opris", Hematologie

Baia Mare, Romania

Location

Institutul Clinic Fundeni, Hematologie

Bucharest, Romania

Location

Spitalul Clinic Coltea, Clinica Hematologie

Bucharest, Romania

Location

Spitalul Clinic Universitar de Urgenta Bucuresti, Hematologie

Bucharest, Romania

Location

Spitalul Clinic Judetean de Urgenta "Sf. Spiridon" Iasi, Oncologie Medicala

Iași, Romania

Location

Arkhangelsk Regional Clinical Hospital

Arkhangelsk, Russia

Location

Belgorod Regional Oncology Center

Belgorod, Russia

Location

Chelyabinsk Regional Oncology Center

Chelyabinsk, Russia

Location

1st Republican Clinical Hospital of Udmurtia

Izhevsk, Russia

Location

Cancer Research Center RAMS - N.N. Blokhin - Academy of Medical Science

Moscow, Russia

Location

Hematology Scientific Center

Moscow, Russia

Location

Moscow Regional Clinical Research Institute

Moscow, Russia

Location

S.P. Botkin Moscow City Clinical Hospital

Moscow, Russia

Location

Nizhniy Novgorod Region Clinical Hospital

Nizhny Novgorod, Russia

Location

Medical Scientific Radiology - Center

Obninsk, Russia

Location

Omsk Regional Oncology Dispensary

Omsk, Russia

Location

Medical Sanitary Unit # 1

Perm, Russia

Location

Republikan Hospital named after V.A/ Baranov

Petrozavodsk, Russia

Location

Rostov Research Institute of Oncology

Rostov-on-Don, Russia

Location

Central Res. Inst. of Roentgen-Radiology

Saint Petersburg, Russia

Location

City Clinical Oncology Dispensary

Saint Petersburg, Russia

Location

Leningrad Region Clinical Hospital

Saint Petersburg, Russia

Location

Pavlov State Medical Univercity

Saint Petersburg, Russia

Location

St.-Petersburg Clinical Research Institute of Hematology and Transfusiology

Saint Petersburg, Russia

Location

Sverdlovsk Regional Oncology Dispensary

Yekaterinburg, Russia

Location

National Cancer Centre

Singapore, Singapore

Location

Singapore General Hospital - Hematology

Singapore, Singapore

Location

Chris Hani Baragwanath Hospital

Johannesburg, Gauteng, South Africa

Location

Medical Oncology Center of Rosebank

Johannesburg, Gauteng, South Africa

Location

University of the Witwatersrand Oncology

Johannesburg, Gauteng, South Africa

Location

Pretoria Academic Hospital-Dr. Savage Road, 3rd Floor Radiotherapy Building, Prinshof

Pretoria, Gauteng, South Africa

Location

Dr AI Pirjol & Dr WM Szpak Inc.

Durban, KwaZulu-Natal, South Africa

Location

Hospital Universitario Germans Trias i Pujol

Badalona, Barcelona, Spain

Location

Hospital Clinic I Provincial de Barcelona

Barcelona, Spain

Location

Hospital de la Princesa

Madrid, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, Spain

Location

Hospital Clinico Universitario Salamanca

Salamanca, Spain

Location

Chang Gung Memorial Hospital, Linkou

Taoyuan District, Taiwan

Location

King Chulalongkorn Memorial Hospital

Bangkok, Thailand

Location

Ramathibodi Hospital

Bangkok, Thailand

Location

Siriraj Hospital-Hematology Unit

Bangkok, Thailand

Location

Maharaj Nakorn Chiang Mai hospital - Faculty of Medicine

Chiang Mai, Thailand

Location

Hôpital Farhat Hached

Sousse, Tunisia

Location

Centre National de Greffe de Moelle osseuse

Tunis, Tunisia

Location

Hôpital Aziza Othmana

Tunis, Tunisia

Location

Institut Salah Azaiz

Tunis, Tunisia

Location

Hacettepe University Medical Faculty

Ankara, Turkey (Türkiye)

Location

Dokuz Eylul University Med. Fac.

Izmir, Turkey (Türkiye)

Location

Cherkassy Regional Oncology Center, Dept. of Hematology

Cherkassy, Ukraine

Location

Dnepropetrovsk City Clinical Hospital #4, Regional Hematology Center

Dnipro, Ukraine

Location

Institute of Urgent and Recovery Surgery named after V.K.Gusaka of AMS of Ukraine, Haematology Dept.

Donetsk, Ukraine

Location

Khmelnitskiy Regional Hospital, Hematology Department

Khmelnitsky, Ukraine

Location

National Cancer Institute, Department of chemotherapy of hemoblastosis

Kiev, Ukraine

Location

Institute of Blood Pathology and Transfusion Medicine, Lviv Clinical Hospital #5, Hematology Dept.

Lviv, Ukraine

Location

Crimean Republic Clinical Oncology Dispensary, Haematology Department

Simferopol, Ukraine

Location

Related Publications (4)

• Robak T, Jin J, Pylypenko H, Verhoef G, Siritanaratkul N, Drach J, Raderer M, Mayer J, Pereira J, Tumyan G, Okamoto R, Nakahara S, Hu P, Appiani C, Nemat S, Cavalli F; LYM-3002 investigators. Frontline bortezomib, rituximab, cyclophosphamide, doxorubicin, and prednisone (VR-CAP) versus rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in transplantation-ineligible patients with newly diagnosed mantle cell lymphoma: final overall survival results of a randomised, open-label, phase 3 study. Lancet Oncol. 2018 Nov;19(11):1449-1458. doi: 10.1016/S1470-2045(18)30685-5. Epub 2018 Oct 19.

  PMID: 30348538 DERIVED

• Robak T, Huang H, Jin J, Zhu J, Liu T, Samoilova O, Pylypenko H, Verhoef G, Siritanaratkul N, Osmanov E, Pereira J, Mayer J, Hong X, Okamoto R, Pei L, Rooney B, van de Velde H, Cavalli F. Association between bortezomib dose intensity and overall survival in mantle cell lymphoma patients on frontline VR-CAP in the phase 3 LYM-3002 study. Leuk Lymphoma. 2019 Jan;60(1):172-179. doi: 10.1080/10428194.2017.1321750. Epub 2017 Jun 5.

  PMID: 28583031 DERIVED

• Verhoef G, Robak T, Huang H, Pylypenko H, Siritanaratkul N, Pereira J, Drach J, Mayer J, Okamoto R, Pei L, Rooney B, Cakana A, van de Velde H, Cavalli F. Association between quality of response and outcomes in patients with newly diagnosed mantle cell lymphoma receiving VR-CAP versus R-CHOP in the phase 3 LYM-3002 study. Haematologica. 2017 May;102(5):895-902. doi: 10.3324/haematol.2016.152496. Epub 2017 Feb 9.

  PMID: 28183846 DERIVED

• Robak T, Huang H, Jin J, Zhu J, Liu T, Samoilova O, Pylypenko H, Verhoef G, Siritanaratkul N, Osmanov E, Alexeeva J, Pereira J, Drach J, Mayer J, Hong X, Okamoto R, Pei L, Rooney B, van de Velde H, Cavalli F; LYM-3002 Investigators. Bortezomib-based therapy for newly diagnosed mantle-cell lymphoma. N Engl J Med. 2015 Mar 5;372(10):944-53. doi: 10.1056/NEJMoa1412096.

  PMID: 25738670 DERIVED

MeSH Terms

Conditions

Lymphoma, Mantle-Cell

Interventions

Rituximab; Cyclophosphamide; Doxorubicin; Bortezomib; Prednisone; Vincristine

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Pyrazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Medical Director Clinical Science

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2008
• First Posted: July 25, 2008
• Study Start: May 1, 2008
• Primary Completion: January 1, 2014
• Study Completion: June 17, 2017
• Last Updated: July 12, 2018
• Results First Posted: November 17, 2014

Record last verified: 2018-06

Locations

TH (4); TU (4); CL (3); DE (9); MY (2); CN (9); BR (11); ZA (5); BE (9); PL (4); UA (7); CO (3); PH (2); RO (5); IT (5); HU (3); RU (20); IL (5); ES (5); CZ (3); SG (2); IN (7); US (9); AU (2); CA (2); MO (3); TW (1); PT (4)