AzTrials
AzTrials

Mantle Cell LymphomaPhase 3NCT00722137

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

A Phase 3 study testing Rituximab 375 mg/m^2, Cyclophosphamide 750 mg/m^2 and Doxorubicin 50 mg/m^2 in people with Mantle Cell Lymphoma, run by Millennium Pharmaceuticals, Inc. at 150 sites in 29 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Mantle Cell Lymphoma
What is being tested?
Rituximab 375 mg/m^2, Cyclophosphamide 750 mg/m^2 and Doxorubicin 50 mg/m^2
Could I receive a placebo?
No, everyone receives an active treatment
How many people
487 participants
Where
150 sitesin 29 countries
Study dates
1 May 2008to 17 Jun 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
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  • 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

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

150 sites in 29 countries.

150 sites in 29 countries

Russia20 sites

  • Arkhangelsk Regional Clinical Hospital

    Arkhangelsk

  • Belgorod Regional Oncology Center

    Belgorod

  • Chelyabinsk Regional Oncology Center

    Chelyabinsk

  • 1st Republican Clinical Hospital of Udmurtia

    Izhevsk

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

    Moscow

  • Hematology Scientific Center

    Moscow

  • Moscow Regional Clinical Research Institute

    Moscow

  • S.P. Botkin Moscow City Clinical Hospital

    Moscow

  • Nizhniy Novgorod Region Clinical Hospital

    Nizhny Novgorod

  • Medical Scientific Radiology - Center

    Obninsk

  • Omsk Regional Oncology Dispensary

    Omsk

  • Medical Sanitary Unit # 1

    Perm

  • Republikan Hospital named after V.A/ Baranov

    Petrozavodsk

  • Rostov Research Institute of Oncology

    Rostov-on-Don

  • Central Res. Inst. of Roentgen-Radiology

    Saint Petersburg

  • City Clinical Oncology Dispensary

    Saint Petersburg

  • Leningrad Region Clinical Hospital

    Saint Petersburg

  • Pavlov State Medical Univercity

    Saint Petersburg

  • St.-Petersburg Clinical Research Institute of Hematology and Transfusiology

    Saint Petersburg

  • Sverdlovsk Regional Oncology Dispensary

    Yekaterinburg

Other trials in Russia

Brazil11 sites

  • Centro de Hematologia E Hemoterapia - Unicamp

    Campinas

  • Fundacao Hospital Amaral Carvalho

    Jaú

  • Hospital Nossa Senhora da Conceicao

    Porto Alegre

  • Hospital Sao Lucas Puc-Rs

    Porto Alegre

  • Inca - Instituto Nacional Do Cancêr

    Rio de Janeiro

  • Centro de Estudos de Hematologia E Oncologia Da Fmabc

    São Paulo

  • Fundacao Pio XII - Hospital de Cancer de Barretos

    São Paulo

  • Hospital Ac Camargo

    São Paulo

  • Hospital Alemao Oswaldo Cruz

    São Paulo

  • Hospital das Clínicas da Faculdade de Medicina da USP

    São Paulo

  • Santa Casa de Misericórida de São Paulo

    São Paulo

Other trials in Brazil

United States9 sites

  • Cancer Outreach Associates, PC

    Abingdon, Virginia, 24211

  • Sinai Hospital

    Baltimore, Maryland, 21215

  • Legacy Pharma Research

    Bismarck, North Dakota, 58501

  • Center for Cancer Care at Goshen Hospital

    Goshen, Indiana, 46526

  • St. Francis Hosptial and Medical Center

    Hartford, Connecticut, 06105

  • Capitol Comp. Cancer Center

    Jefferson City, Missouri, 65109

  • Hematology-Oncology Associates of Northern NJ

    Morristown, New Jersey, 07960

  • Division of Hematology and Oncology Vanderbilt University

    Nashville, Tennessee, 37232

  • Nebraska Cancer Specialists

    Omaha, Nebraska, 68114

Other trials in United States

Belgium9 sites

  • AZ Stuivenberg Oncologie/ Hematologie

    Antwerp

  • AZ St Jan AV

    Bruges

  • UZ Brussel Department Medical Oncology

    Brussels

  • UZA Hematologie, 1e verdiep

    Edegem

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

    Ghent

  • UZ Leuven Gasthuisberg Hematologie

    Leuven

  • C.H.R. Citadelle

    Liège

  • Centre Hospitalier Universitaire

    Liège

  • Ucl de Mont-Godinne

    Yvoir

Other trials in Belgium

China9 sites

  • Beijing Cancer Hospital

    Beijing

  • Cancer Institute & Cancer Hospital, CAMS&PUMC

    Beijing

  • Peking University Third Hospital

    Beijing

  • West China Hospital, Sichuan University

    Chengdu, Sichuan

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong

  • Zhejiang University First Hospital

    Hangzhou, Zhejiang

  • Cancer hospital, Fudan University

    Shanghai

  • Ruijin Hospital

    Shanghai

  • Tianjin Medical University Cancer Hospital and Institute

    Tianjin

Other trials in China

Germany9 sites

  • Vivantes Klinikum Neukölln Klinik für Innere Medizin Hämatologie und Onkologie

    Berlin

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

    Berlin

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

    Frankfurt

  • Tumorklinik SANAFONTIS Alpine GmbH

    Freiburg im Breisgau

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

    Goch

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

    Lemgo

  • Johannes-Gutenberg-Universität Mainz III. Med. Klinik

    Mainz

  • Mutterhaus der Borromäerinnen Med. Klinik I

    Trier

  • Schwarzwald-Baar-Kliniken Innere Med. II

    Villingen

Other trials in Germany

India7 sites

  • Kidwai Memorial Institute of Oncology

    Bangalore 560 029, Karnataka

  • Apollo Speciality Hospital, Chennai

    Chennai-600035, Tamil Nadu

  • Apollo Hospital and Research Foundation, Apollo Hospitals

    Hyderabad 500033, Andhra Pradesh

  • Netaji Subash Chanda Bose Cancer Research Institute

    Kolkata- 700016, West Bengal

  • Sir Ganga Ram Hospital

    New Delhi- 110060, National Capital Territory of Delhi

  • Jehangir Hospital

    Pune-411002, Maharashtra

  • Regional Cancer Centre, Medical Oncology

    Thiruvananthapuram, Kerala-695011

Other trials in India

Ukraine7 sites

  • Cherkassy Regional Oncology Center, Dept. of Hematology

    Cherkassy

  • Dnepropetrovsk City Clinical Hospital #4, Regional Hematology Center

    Dnipro

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

    Donetsk

  • Khmelnitskiy Regional Hospital, Hematology Department

    Khmelnitsky

  • National Cancer Institute, Department of chemotherapy of hemoblastosis

    Kiev

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

    Lviv

  • Crimean Republic Clinical Oncology Dispensary, Haematology Department

    Simferopol

Other trials in Ukraine

Israel5 sites

  • Rambam Medical Center-Hematology department

    Haifa

  • Hadassah Medical Center - Hematology department

    Jerusalem

  • Rabin Medical Center, Beilinson Campus

    Petach Tiqva

  • Sheba Medical Center

    Ramat Gan

  • Kaplan Medical Center - Hematology Institute

    Rehovot

Other trials in Israel

Italy5 sites

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

    Bologna

  • Spedali Civili di Brescia

    Brescia

  • Dipartimento di Oncologia ed Ematologia Università di Modena e Reggio Emilia

    Modena

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

    Roma

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

    Torino

Other trials in Italy

Romania5 sites

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

    Baia Mare

  • Institutul Clinic Fundeni, Hematologie

    Bucharest

  • Spitalul Clinic Coltea, Clinica Hematologie

    Bucharest

  • Spitalul Clinic Universitar de Urgenta Bucuresti, Hematologie

    Bucharest

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

    Iași

Other trials in Romania

South Africa5 sites

  • Dr AI Pirjol & Dr WM Szpak Inc.

    Durban, KwaZulu-Natal

  • Chris Hani Baragwanath Hospital

    Johannesburg, Gauteng

  • Medical Oncology Center of Rosebank

    Johannesburg, Gauteng

  • University of the Witwatersrand Oncology

    Johannesburg, Gauteng

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

    Pretoria, Gauteng

Other trials in South Africa

Spain5 sites

  • Hospital Universitario Germans Trias i Pujol

    Badalona, Barcelona

  • Hospital Clinic I Provincial de Barcelona

    Barcelona

  • Hospital de la Princesa

    Madrid

  • Hospital Universitario 12 de Octubre

    Madrid

  • Hospital Clinico Universitario Salamanca

    Salamanca

Other trials in Spain

Poland4 sites

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

    Gdynia

  • Klinika Hematologii Uniwersytetu Medycznego w Lodzi

    Lodz

  • "Katedra i Klinika Hematologii i Chorob Rozrostowych Ukladu Krwiotworczego

    Poznan

  • Klinika Hematologii Nowotworow Krwi i Transplantacji Szpiku Akademii Medycznej we Wroclawiu

    Wroclaw

Other trials in Poland

Portugal4 sites

  • Hospital Sao Marcos

    Braga

  • Hospitais da Universidade de Coimbra

    Coimbra

  • Hospital de Santa Maria

    Lisbon

  • Instituto Portugues de Oncologia

    Porto

Other trials in Portugal

Thailand4 sites

  • King Chulalongkorn Memorial Hospital

    Bangkok

  • Ramathibodi Hospital

    Bangkok

  • Siriraj Hospital-Hematology Unit

    Bangkok

  • Maharaj Nakorn Chiang Mai hospital - Faculty of Medicine

    Chiang Mai

Other trials in Thailand

Tunisia4 sites

  • Hôpital Farhat Hached

    Sousse

  • Centre National de Greffe de Moelle osseuse

    Tunis

  • Hôpital Aziza Othmana

    Tunis

  • Institut Salah Azaiz

    Tunis

Other trials in Tunisia

Chile3 sites

  • Hospital Clinico Universidad Catolica de Chile

    Santiago

  • Hospital Del Salvador

    Santiago

  • Instituto Nacional Del Cancer

    Santiago

Other trials in Chile

Colombia3 sites

  • Clinica Reina Sofia

    Bogotá

  • Hospital Pablo Tobon Uribe

    Medellín

  • Hospital Universitario San Vicente de Paul

    Medellín

Other trials in Colombia

Czechia3 sites

  • Interni hematoonkoligicka klinika

    Brno

  • Interni klinika - Oddeleni klin. hematologie Fakultni nemocnice Hradec Kralove

    Hradec Králové

  • Oddeleni klinicke hematologie, Fakultni nemocnice Kralovske Vinohrady

    Prague

Other trials in Czechia

Hungary3 sites

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

    Debrecen

  • Petz Aladár Kórház, II. Belgyógyászat

    Győr

  • Kaposi Mor Megyei Korhaz, Belgyogyaszat

    Kaposvár

Other trials in Hungary

Morocco3 sites

  • Hopital Du 20 Aout 1953

    Casablanca

  • Centre D'oncologie Al Azhar

    Rabat

  • Institut National D'oncologie

    Rabat

Other trials in Morocco

Austria2 sites

  • St.Johanns Spital/Landeskrankenhaus Salzburg

    Salzburg

  • Allgemeines Krankenhaus der Stadt Wien

    Vienna

Other trials in Austria

Canada2 sites

  • Cross Cancer Institute

    Edmonton, Alberta

  • University Health Network, Princess Margaret Hospital

    Toronto, Ontario

Other trials in Canada

Malaysia2 sites

  • University Malaya Medical Centre

    Kuala Lumpur

  • Gleneagles Medical Centre

    Pulau Pinang

Other trials in Malaysia

Philippines2 sites

  • National Kidney and Transplant Institute

    Quezon City

  • St Lukes Medical Center

    Quezon City

Other trials in Philippines

Singapore2 sites

  • National Cancer Centre

    Singapore

  • Singapore General Hospital - Hematology

    Singapore

Other trials in Singapore

Turkey (Türkiye)2 sites

  • Hacettepe University Medical Faculty

    Ankara

  • Dokuz Eylul University Med. Fac.

    Izmir

Other trials in Turkey (Türkiye)

Taiwan1 site

  • Chang Gung Memorial Hospital, Linkou

    Taoyuan

Other trials in Taiwan

About this study

Official title: A Randomized, Open-Label, Multicenter Phase 3 Study of the Combination of Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone (VcR-CAP) or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Patients With Newly Diagnosed Mantle Cell Lymphoma Who Are Not Eligible for a Bone Marrow Transplant

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.

Read the 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.

Being tested
Rituximab 375 mg/m^2, Cyclophosphamide 750 mg/m^2, Doxorubicin 50 mg/m^2, VELCADE 1.3 mg/m^2, Prednisone 100 mg/m^2
Medical subject headings
Lymphoma, Mantle-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rituximab 375 mg/m^2Drug

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

  • Cyclophosphamide 750 mg/m^2Drug

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

  • Doxorubicin 50 mg/m^2Drug

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

  • VELCADE 1.3 mg/m^2Drug

    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^2Drug

    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^2Drug

    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.

Study groups in NCT00722137
Study groupRoleWhat they receive
R-CHOPActive comparatorRituximab 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
Receives: 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-CAPExperimentalRituximab 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
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Median duration of follow-up of 40 months

Secondary outcomes (10)

  1. Time to Progression (TTP)

    Time to progression was defined as the duration from the date of randomization until the date of first documented evidence of progressive disease (PD) or date of relapse for subjects who experienced complete response (CR) or complete response, unconfirmed (CRu). PD and response were based on the assessment of an Independent Review Committee.

    Measured: Median duration of follow-up of 40 months

  2. Duration of Response

    The duration of treatment response was defined as the time from the date of the first response to the date of PD or death due to PD for those participants with a best response of CR, CRu, or PR as determined by the Independent Review Committee. The duration of response for complete responders was defined as the time from the date of the first response to the date of PD or death due to PD for those participants with a best response of CR or CRu verified by bone marrow and lactate dehydrogenase (LDH).

    Measured: Median duration of follow-up of 40 months

  3. Time to Next Anti-lymphoma Treatment (TTNT)

    The time to next anti-lymphomatreatment was measured from the date of initiation of study treatment as per protocol to the start date of new anti-lymphoma treatment. Death due to disease progression prior to subsequent therapy was considered as an event. Otherwise, time to next anti lymphoma treatment was censored at the date of death or the last date known to be alive.

    Measured: : Median duration of follow-up of 40 months

  4. Treatment-free Interval (TFI)

    The TFI was defined as the duration from the date of last dose plus 1 day to the start date of the new treatment. Death due to disease progression prior to subsequent therapy was considered as an event. Otherwise, treatment-free interval was censored at the date of death or the last date known to be alive.

    Measured: Median duration of follow-up of 40 months

  5. Overall Response Rate (ORR)

    ORR was defined as complete response (CR) + complete response, unconfirmed (CRu) + partial response (PR) as determined by the Independent Review Committee. Response assessment was carried out every 6 weeks for 18 weeks; thereafter, every 8 weeks until PD/initiation of alternate therapy/withdrawal from study/death.

    Measured: Median duration of follow-up of 40 months

  6. Overall Complete Response (CR + CRu)

    Overall complete response was defined as the number of participants with complete response (CR) and those with unconfirmed complete response (CRu). Response assessment was carried out every 6 weeks for 18 weeks; thereafter, every 8 weeks until PD/initiation of alternate therapy/withdrawal from study/death.

    Measured: Median duration of follow-up of 40 months

  7. Overall Survival (OS)

    OS was measured from the date of randomization to the date of the participant's death. If the participant was alive or the vital status was unknown, OS was censored at the date that the subject was last known to be alive.

    Measured: Median duration of follow-up of 40 months

  8. 18-Month Survival

    18-month survival was defined as the estimated probability of survival at 18 months (Kaplan-Meier estimate).

    Measured: Up to month 18 from the time of randomization

  9. Overall Survival (OS) in Long Term Follow-up Period

    OS was measured from the date of randomization to the date of the participant's death. If the participant was alive or the vital status was unknown, OS was censored at the date that the subject was last known to be alive.

    Measured: Up to 107.4 months

  10. Number of Participants Experiencing an Adverse Event (AE)

    An AE was defined as any untoward medical occurrence associated with the use of a drug, whether or not considered drug related. AEs were collected from the first dose of study drug through 30 days after the last dose of study drug. Treatment was administered for up to 8 cycles (24 weeks) and AEs were collected for up to 30 days following the last dose of study drug.

    Measured: Up to 107.4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2008 (estimated)
  2. Study start1 May 2008
  3. Primary completion1 Jan 2014
  4. Study completion17 Jun 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
487 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00722137
Sponsor's protocol ID
26866138-LYM-3002
Other IDs
26866138-LYM-3002CTIL, 2007-005669-37, 0970313683, U1111-1195-3827
Status last verified
Jun 2018
First submitted
23 Jul 2008
Last updated
12 Jul 2018
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 30348538

  • 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.

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Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rituximab 375 mg/m^2, Cyclophosphamide 750 mg/m^2 and Doxorubicin 50 mg/m^2 in people with Mantle Cell Lymphoma, run by Millennium Pharmaceuticals, Inc. at 150 sites in 29 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 150 sites in Russia, Brazil, United States, Belgium, China and 24 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) (time frame: Median duration of follow-up of 40 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00722137, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2018.

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