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

NCT ID: NCT00722137

Last Updated: 2018-07-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 487 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-01
• Study Completion Date: 2017-06-17

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.

Detailed Description

The drug being tested in this study were combination of VcR-CAP and R-CHOP. Combination of VcR-CAP and R-CHOP is being tested to treat people who had mantle cell lymphoma (MCL).

The study enrolled 487 patients. Participants were randomly assigned (by chance, like flipping a coin) to one of the two treatment groups in a 1:1 ratio:

Treatment Group A (VcR-CAP) Treatment Group B (R-CHOP)

The study included a screening phase, a treatment phase, a short-term follow-up phase, and a long-term follow-up phase. The screening phase was up to 28 days (56 days for bone marrow evaluation) prior to randomization.

This multi-center trial was conducted worldwide. The total study duration from randomization of the first patient until the last progression-free survival (PFS) event required for the final analysis was expected to be approximately 42 months (24 months for enrollment and 18 months for follow-up) and survival follow-up every 12 weeks until death.

Conditions

Mantle Cell Lymphoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

R-CHOP

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

Group Type: ACTIVE_COMPARATOR

Rituximab 375 mg/m^2

Intervention Type: DRUG

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

Cyclophosphamide 750 mg/m^2

Intervention Type: DRUG

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

Doxorubicin 50 mg/m^2

Intervention Type: DRUG

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

Prednisone 100 mg/m^2

Intervention Type: DRUG

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

Vincristine 1.4 mg/m^2

Intervention Type: 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.

VcR-CAP

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

Group Type: EXPERIMENTAL

Rituximab 375 mg/m^2

Intervention Type: DRUG

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

Cyclophosphamide 750 mg/m^2

Intervention Type: DRUG

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

Doxorubicin 50 mg/m^2

Intervention Type: DRUG

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

VELCADE 1.3 mg/m^2

Intervention Type: DRUG

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

Prednisone 100 mg/m^2

Intervention Type: DRUG

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

Interventions

Rituximab 375 mg/m^2

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

Intervention Type: DRUG

Cyclophosphamide 750 mg/m^2

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

Intervention Type: DRUG

Doxorubicin 50 mg/m^2

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

Intervention Type: DRUG

VELCADE 1.3 mg/m^2

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

Intervention Type: DRUG

Prednisone 100 mg/m^2

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

Intervention Type: DRUG

Vincristine 1.4 mg/m^2

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.
• All patients (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
• In order to participate in the pharmacogenomics component of this study, patients (or their legally acceptable representative) must have signed the informed consent form for pharmacogenomics research indicating willingness to participate in the pharmacogenomics component of the study. Acquisition of tumor sample collections is required for all patients (where available); all other sample collections are optional

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

INDUSTRY

Sponsor Role: collaborator

Millennium Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director Clinical Science

Role: STUDY_DIRECTOR

Takeda

Locations

St. Francis Hosptial and Medical Center

Hartford, Connecticut, United States

Center for Cancer Care at Goshen Hospital

Goshen, Indiana, United States

Sinai Hospital

Baltimore, Maryland, United States

Capitol Comp. Cancer Center

Jefferson City, Missouri, United States

Nebraska Cancer Specialists

Omaha, Nebraska, United States

Hematology-Oncology Associates of Northern NJ

Morristown, New Jersey, United States

Legacy Pharma Research

Bismarck, North Dakota, United States

Division of Hematology and Oncology Vanderbilt University

Nashville, Tennessee, United States

Cancer Outreach Associates, PC

Abingdon, Virginia, United States

St.Johanns Spital/Landeskrankenhaus Salzburg

Salzburg, , Austria

Allgemeines Krankenhaus der Stadt Wien

Vienna, , Austria

AZ Stuivenberg Oncologie/ Hematologie

Antwerp, , Belgium

AZ St Jan AV

Bruges, , 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

Ghent, , Belgium

UZ Leuven Gasthuisberg Hematologie

Leuven, , Belgium

C.H.R. Citadelle

Liège, , Belgium

Centre Hospitalier Universitaire

Liège, , Belgium

Ucl de Mont-Godinne

Yvoir, , Belgium

Centro de Hematologia E Hemoterapia - Unicamp

Campinas, , Brazil

Fundacao Hospital Amaral Carvalho

Jaú, , Brazil

Hospital Nossa Senhora da Conceicao

Porto Alegre, , Brazil

Hospital Sao Lucas Puc-Rs

Porto Alegre, , Brazil

Inca - Instituto Nacional Do Cancêr

Rio de Janeiro, , Brazil

Centro de Estudos de Hematologia E Oncologia Da Fmabc

São Paulo, , Brazil

Fundacao Pio XII - Hospital de Cancer de Barretos

São Paulo, , Brazil

Hospital Ac Camargo

São Paulo, , Brazil

Hospital Alemao Oswaldo Cruz

São Paulo, , Brazil

Hospital das Clínicas da Faculdade de Medicina da USP

São Paulo, , Brazil

Santa Casa de Misericórida de São Paulo

São 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

Hospital Del Salvador

Santiago, , Chile

Instituto Nacional Del Cancer

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

Beijing Cancer Hospital

Beijing, , China

Cancer Institute & Cancer Hospital, CAMS&PUMC

Beijing, , China

Peking University Third Hospital

Beijing, , China

Cancer hospital, Fudan University

Shanghai, , China

Ruijin Hospital

Shanghai, , China

Tianjin Medical University Cancer Hospital and Institute

Tianjin, , China

Clinica Reina Sofia

Bogotá, , Colombia

Hospital Pablo Tobon Uribe

Medellín, , Colombia

Hospital Universitario San Vicente de Paul

Medellín, , Colombia

Interni hematoonkoligicka klinika

Brno, , Czechia

Interni klinika - Oddeleni klin. hematologie Fakultni nemocnice Hradec Kralove

Hradec Králové, , Czechia

Oddeleni klinicke hematologie, Fakultni nemocnice Kralovske Vinohrady

Prague, , Czechia

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 im Breisgau, , 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

Kaposvár, , Hungary

Apollo Hospital and Research Foundation, Apollo Hospitals

Hyderabad 500033, Andhra Pradesh, 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

Sir Ganga Ram Hospital

New Delhi- 110060, National Capital Territory of Delhi, 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

Rehovot, , 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

National Kidney and Transplant Institute

Quezon City, , Philippines

St Lukes Medical Center

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

Lisbon, , Portugal

Instituto Portugues de Oncologia

Porto, , Portugal

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

Baia Mare, , Romania

Institutul Clinic Fundeni, Hematologie

Bucharest, , Romania

Spitalul Clinic Coltea, Clinica Hematologie

Bucharest, , Romania

Spitalul Clinic Universitar de Urgenta Bucuresti, Hematologie

Bucharest, , Romania

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

Iași, , Romania

Arkhangelsk Regional Clinical Hospital

Arkhangelsk, , Russia

Belgorod Regional Oncology Center

Belgorod, , Russia

Chelyabinsk Regional Oncology Center

Chelyabinsk, , Russia

1st Republican Clinical Hospital of Udmurtia

Izhevsk, , Russia

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

Moscow, , Russia

Hematology Scientific Center

Moscow, , Russia

Moscow Regional Clinical Research Institute

Moscow, , Russia

S.P. Botkin Moscow City Clinical Hospital

Moscow, , Russia

Nizhniy Novgorod Region Clinical Hospital

Nizhny Novgorod, , Russia

Medical Scientific Radiology - Center

Obninsk, , Russia

Omsk Regional Oncology Dispensary

Omsk, , Russia

Medical Sanitary Unit # 1

Perm, , Russia

Republikan Hospital named after V.A/ Baranov

Petrozavodsk, , Russia

Rostov Research Institute of Oncology

Rostov-on-Don, , Russia

Central Res. Inst. of Roentgen-Radiology

Saint Petersburg, , Russia

City Clinical Oncology Dispensary

Saint Petersburg, , Russia

Leningrad Region Clinical Hospital

Saint Petersburg, , Russia

Pavlov State Medical Univercity

Saint Petersburg, , Russia

St.-Petersburg Clinical Research Institute of Hematology and Transfusiology

Saint Petersburg, , Russia

Sverdlovsk Regional Oncology Dispensary

Yekaterinburg, , Russia

National Cancer Centre

Singapore, , Singapore

Singapore General Hospital - Hematology

Singapore, , Singapore

Chris Hani Baragwanath Hospital

Johannesburg, Gauteng, South Africa

Medical Oncology Center of Rosebank

Johannesburg, Gauteng, South Africa

University of the Witwatersrand Oncology

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

Taoyuan District, , Taiwan

King Chulalongkorn Memorial Hospital

Bangkok, , Thailand

Ramathibodi Hospital

Bangkok, , Thailand

Siriraj Hospital-Hematology Unit

Bangkok, , Thailand

Maharaj Nakorn Chiang Mai hospital - Faculty of Medicine

Chiang Mai, , Thailand

Hôpital Farhat Hached

Sousse, , Tunisia

Centre National de Greffe de Moelle osseuse

Tunis, , Tunisia

Hôpital Aziza Othmana

Tunis, , Tunisia

Institut Salah Azaiz

Tunis, , Tunisia

Hacettepe University Medical Faculty

Ankara, , Turkey (Türkiye)

Dokuz Eylul University Med. Fac.

Izmir, , Turkey (Türkiye)

Cherkassy Regional Oncology Center, Dept. of Hematology

Cherkassy, , Ukraine

Dnepropetrovsk City Clinical Hospital #4, Regional Hematology Center

Dnipro, , 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

Countries

United States; Austria; Belgium; Brazil; Canada; Chile; China; Colombia; Czechia; Germany; Hungary; India; Israel; Italy; Malaysia; Morocco; Philippines; Poland; Portugal; Romania; Russia; Singapore; South Africa; Spain; Taiwan; Thailand; Tunisia; Turkey (Türkiye); Ukraine

References

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.

Reference Type: DERIVED

PMID: 30348538 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28583031 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28183846 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25738670 (View on PubMed)

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

26866138-LYM-3002CTIL

Identifier Type: OTHER

Identifier Source: secondary_id

2007-005669-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

0970313683

Identifier Type: REGISTRY

Identifier Source: secondary_id

U1111-1195-3827

Identifier Type: OTHER

Identifier Source: secondary_id

26866138-LYM-3002

Identifier Type: -

Identifier Source: org_study_id