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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

Primary Purpose

Mantle Cell Lymphoma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
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
Vincristine 1.4 mg/m^2
Sponsored by
Millennium Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mantle Cell Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • St. Francis Hosptial and Medical Center
  • Center for Cancer Care at Goshen Hospital
  • Sinai Hospital
  • Capitol Comp. Cancer Center
  • Nebraska Cancer Specialists
  • Hematology-Oncology Associates of Northern NJ
  • Legacy Pharma Research
  • Division of Hematology and Oncology Vanderbilt University
  • Cancer Outreach Associates, PC
  • St.Johanns Spital/Landeskrankenhaus Salzburg
  • Allgemeines Krankenhaus der Stadt Wien
  • AZ Stuivenberg Oncologie/ Hematologie
  • AZ St Jan AV
  • UZ Brussel Department Medical Oncology
  • UZA Hematologie, 1e verdiep
  • Universitair Ziekenhuis Gent - UZ GENT, Hematologie, 9K12IE 9de verdiep- polikliniek Hematologie
  • UZ Leuven Gasthuisberg Hematologie
  • C.H.R. Citadelle
  • Centre Hospitalier Universitaire
  • Ucl de Mont-Godinne
  • Centro de Hematologia E Hemoterapia - Unicamp
  • Fundacao Hospital Amaral Carvalho
  • Hospital Nossa Senhora da Conceicao
  • Hospital Sao Lucas Puc-Rs
  • Inca - Instituto Nacional Do Cancêr
  • Centro de Estudos de Hematologia E Oncologia Da Fmabc
  • Fundacao Pio XII - Hospital de Cancer de Barretos
  • Hospital Ac Camargo
  • Hospital Alemao Oswaldo Cruz
  • Hospital das Clínicas da Faculdade de Medicina da USP
  • Santa Casa de Misericórida de São Paulo
  • Cross Cancer Institute
  • University Health Network, Princess Margaret Hospital
  • Hospital Clinico Universidad Catolica de Chile
  • Hospital Del Salvador
  • Instituto Nacional Del Cancer
  • Sun Yat-sen University Cancer Center
  • West China Hospital, Sichuan University
  • Zhejiang University First Hospital
  • Beijing Cancer Hospital
  • Cancer Institute & Cancer Hospital, CAMS&PUMC
  • Peking University Third Hospital
  • Cancer hospital, Fudan University
  • Ruijin Hospital
  • Tianjin Medical University Cancer Hospital and Institute
  • Clinica Reina Sofia
  • Hospital Pablo Tobon Uribe
  • Hospital Universitario San Vicente de Paul
  • Interni hematoonkoligicka klinika
  • Interni klinika - Oddeleni klin. hematologie Fakultni nemocnice Hradec Kralove
  • Oddeleni klinicke hematologie, Fakultni nemocnice Kralovske Vinohrady
  • Vivantes Klinikum Neukölln Klinik für Innere Medizin Hämatologie und Onkologie
  • Vivantes Klinikum Spandau Klinik für Innere Medizin - Hämatologie, Onkologie und Gastroenterologie
  • Städt. Kliniken Frankfurt-Hoechst Med. Klinik II - Hämatologie und Onkologie
  • Tumorklinik SANAFONTIS Alpine GmbH
  • Wilhelm-Anton-Hospital Goch gGmbH Klinik für Hämatologie und internistische Onkologie
  • Klinikum Lippe-Lemgo Med. Klinik II - Hämatologie und Onkologie
  • Johannes-Gutenberg-Universität Mainz III. Med. Klinik
  • Mutterhaus der Borromäerinnen Med. Klinik I
  • Schwarzwald-Baar-Kliniken Innere Med. II
  • Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum, III. sz. Belgyogyaszati Klinika
  • Petz Aladár Kórház, II. Belgyógyászat
  • Kaposi Mor Megyei Korhaz, Belgyogyaszat
  • Apollo Hospital and Research Foundation, Apollo Hospitals
  • Sir Ganga Ram Hospital
  • Kidwai Memorial Institute of Oncology
  • Regional Cancer Centre, Medical Oncology
  • Jehangir Hospital
  • Apollo Speciality Hospital, Chennai
  • Netaji Subash Chanda Bose Cancer Research Institute
  • Rambam Medical Center-Hematology department
  • Hadassah Medical Center - Hematology department
  • Rabin Medical Center, Beilinson Campus
  • Sheba Medical Center
  • Kaplan Medical Center - Hematology Institute
  • Azienda Ospedaliera Universitaria di Bologna Policlinico S.Orsola-Malpighi Dipartimento di Ematologia e Scienze Oncologiche "L. e A. Seragnoli"
  • Spedali Civili di Brescia
  • Dipartimento di Oncologia ed Ematologia Università di Modena e Reggio Emilia
  • AZIENDA OSPEDALIERA UNIVERSITARIA POLICLINICO TOR VERGATA DIPARTIMENTO DI MEDICINA U.O.C. Ematologia
  • Azienda Ospedaliera San Giovanni Battista "Molinette" Struttura Complessa Ematologia 2
  • University Malaya Medical Centre
  • Gleneagles Medical Centre
  • Hopital Du 20 Aout 1953
  • Centre D'oncologie Al Azhar
  • Institut National D'oncologie
  • National Kidney and Transplant Institute
  • St Lukes Medical Center
  • Szpital Morski im. PCK w Gdyni Gdynskie Centrum Onkologii Oddzial Chemioterapii
  • Klinika Hematologii Uniwersytetu Medycznego w Lodzi
  • "Katedra i Klinika Hematologii i Chorob Rozrostowych Ukladu Krwiotworczego
  • Klinika Hematologii Nowotworow Krwi i Transplantacji Szpiku Akademii Medycznej we Wroclawiu
  • Hospital Sao Marcos
  • Hospitais da Universidade de Coimbra
  • Hospital de Santa Maria
  • Instituto Portugues de Oncologia
  • Spitalul Judetean de Urgenta "Dr. Constantin Opris", Hematologie
  • Institutul Clinic Fundeni, Hematologie
  • Spitalul Clinic Coltea, Clinica Hematologie
  • Spitalul Clinic Universitar de Urgenta Bucuresti, Hematologie
  • Spitalul Clinic Judetean de Urgenta "Sf. Spiridon" Iasi, Oncologie Medicala
  • Arkhangelsk Regional Clinical Hospital
  • Belgorod Regional Oncology Center
  • Chelyabinsk Regional Oncology Center
  • Sverdlovsk Regional Oncology Dispensary
  • 1st Republican Clinical Hospital of Udmurtia
  • Cancer Research Center RAMS - N.N. Blokhin - Academy of Medical Science
  • Hematology Scientific Center
  • Moscow Regional Clinical Research Institute
  • S.P. Botkin Moscow City Clinical Hospital
  • Nizhniy Novgorod Region Clinical Hospital
  • Medical Scientific Radiology - Center
  • Omsk Regional Oncology Dispensary
  • Medical Sanitary Unit # 1
  • Republikan Hospital named after V.A/ Baranov
  • Rostov Research Institute of Oncology
  • City Clinical Oncology Dispensary
  • Central Res. Inst. of Roentgen-Radiology
  • Pavlov State Medical Univercity
  • Leningrad Region Clinical Hospital
  • St.-Petersburg Clinical Research Institute of Hematology and Transfusiology
  • National Cancer Centre
  • Singapore General Hospital - Hematology
  • Chris Hani Baragwanath Hospital
  • Medical Oncology Center of Rosebank
  • University of the Witwatersrand Oncology
  • Pretoria Academic Hospital-Dr. Savage Road, 3rd Floor Radiotherapy Building, Prinshof
  • Dr AI Pirjol & Dr WM Szpak Inc.
  • Hospital Universitario Germans Trias i Pujol
  • Hospital Clinic I Provincial de Barcelona
  • Hospital de la Princesa
  • Hospital Universitario 12 de Octubre
  • Hospital Clinico Universitario Salamanca
  • Chang Gung Memorial Hospital, Linkou
  • King Chulalongkorn Memorial Hospital
  • Ramathibodi Hospital
  • Siriraj Hospital-Hematology Unit
  • Maharaj Nakorn Chiang Mai hospital - Faculty of Medicine
  • Hôpital Farhat Hached
  • Centre National de Greffe de Moelle osseuse
  • Hôpital Aziza Othmana
  • Institut Salah Azaiz
  • Hacettepe University Medical Faculty
  • Dokuz Eylul University Med. Fac.
  • Cherkassy Regional Oncology Center, Dept. of Hematology
  • Dnepropetrovsk City Clinical Hospital #4, Regional Hematology Center
  • Institute of Urgent and Recovery Surgery named after V.K.Gusaka of AMS of Ukraine, Haematology Dept.
  • Khmelnitskiy Regional Hospital, Hematology Department
  • National Cancer Institute, Department of chemotherapy of hemoblastosis
  • Institute of Blood Pathology and Transfusion Medicine, Lviv Clinical Hospital #5, Hematology Dept.
  • Crimean Republic Clinical Oncology Dispensary, Haematology Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

R-CHOP

VcR-CAP

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
July 23, 2008
Last Updated
June 14, 2018
Sponsor
Millennium Pharmaceuticals, Inc.
Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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1. Study Identification

Unique Protocol Identification Number
NCT00722137
Brief Title
Study of the Combination of Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Mantle Cell Lymphoma
Official Title
A Randomized, Open-Label, 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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
May 1, 2008 (Actual)
Primary Completion Date
January 1, 2014 (Actual)
Study Completion Date
June 17, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Millennium Pharmaceuticals, Inc.
Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mantle Cell Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
487 (Actual)

8. Arms, Groups, and Interventions

Arm Title
R-CHOP
Arm Type
Active Comparator
Arm Description
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
Arm Title
VcR-CAP
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Rituximab 375 mg/m^2
Intervention Description
Intravenous rituximab 375 mg/m^2 on Day 1 of a 21-day (3 week) cycle for 6 cycles.
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide 750 mg/m^2
Intervention Description
Intravenous cyclophosphamide 750 mg/m^2 on Day 1 of a 21-day (3 week) cycle for 6 cycles
Intervention Type
Drug
Intervention Name(s)
Doxorubicin 50 mg/m^2
Intervention Description
Intravenous doxorubicin 50 mg/m^2 on Day 1 of a 21-day (3 week) cycle for 6 cycles
Intervention Type
Drug
Intervention Name(s)
VELCADE 1.3 mg/m^2
Intervention Description
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
Intervention Name(s)
Prednisone 100 mg/m^2
Intervention Description
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
Intervention Name(s)
Vincristine 1.4 mg/m^2
Intervention Description
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.
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Description
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.
Time Frame
Median duration of follow-up of 40 months
Secondary Outcome Measure Information:
Title
Time to Progression (TTP)
Description
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.
Time Frame
Median duration of follow-up of 40 months
Title
Duration of Response
Description
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).
Time Frame
Median duration of follow-up of 40 months
Title
Time to Next Anti-lymphoma Treatment (TTNT)
Description
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.
Time Frame
: Median duration of follow-up of 40 months
Title
Treatment-free Interval (TFI)
Description
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.
Time Frame
Median duration of follow-up of 40 months
Title
Overall Response Rate (ORR)
Description
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.
Time Frame
Median duration of follow-up of 40 months
Title
Overall Complete Response (CR + CRu)
Description
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.
Time Frame
Median duration of follow-up of 40 months
Title
Overall Survival (OS)
Description
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.
Time Frame
Median duration of follow-up of 40 months
Title
18-Month Survival
Description
18-month survival was defined as the estimated probability of survival at 18 months (Kaplan-Meier estimate).
Time Frame
Up to month 18 from the time of randomization
Title
Overall Survival (OS) in Long Term Follow-up Period
Description
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.
Time Frame
Up to 107.4 months
Title
Number of Participants Experiencing an Adverse Event (AE)
Description
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.
Time Frame
Up to 107.4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director Clinical Science
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
St. Francis Hosptial and Medical Center
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06105
Country
United States
Facility Name
Center for Cancer Care at Goshen Hospital
City
Goshen
State/Province
Indiana
ZIP/Postal Code
46526
Country
United States
Facility Name
Sinai Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Facility Name
Capitol Comp. Cancer Center
City
Jefferson City
State/Province
Missouri
ZIP/Postal Code
65109
Country
United States
Facility Name
Nebraska Cancer Specialists
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Hematology-Oncology Associates of Northern NJ
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
Legacy Pharma Research
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
Division of Hematology and Oncology Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Cancer Outreach Associates, PC
City
Abingdon
State/Province
Virginia
ZIP/Postal Code
24211
Country
United States
Facility Name
St.Johanns Spital/Landeskrankenhaus Salzburg
City
Salzburg
Country
Austria
Facility Name
Allgemeines Krankenhaus der Stadt Wien
City
Wien
Country
Austria
Facility Name
AZ Stuivenberg Oncologie/ Hematologie
City
Antwerpen
Country
Belgium
Facility Name
AZ St Jan AV
City
Brugge
Country
Belgium
Facility Name
UZ Brussel Department Medical Oncology
City
Brussels
Country
Belgium
Facility Name
UZA Hematologie, 1e verdiep
City
Edegem
Country
Belgium
Facility Name
Universitair Ziekenhuis Gent - UZ GENT, Hematologie, 9K12IE 9de verdiep- polikliniek Hematologie
City
Gent
Country
Belgium
Facility Name
UZ Leuven Gasthuisberg Hematologie
City
Leuven
Country
Belgium
Facility Name
C.H.R. Citadelle
City
Liege
Country
Belgium
Facility Name
Centre Hospitalier Universitaire
City
Liege
Country
Belgium
Facility Name
Ucl de Mont-Godinne
City
Yvoir
Country
Belgium
Facility Name
Centro de Hematologia E Hemoterapia - Unicamp
City
Campinas
Country
Brazil
Facility Name
Fundacao Hospital Amaral Carvalho
City
Jau
Country
Brazil
Facility Name
Hospital Nossa Senhora da Conceicao
City
Porto Alegre
Country
Brazil
Facility Name
Hospital Sao Lucas Puc-Rs
City
Porto Alegre
Country
Brazil
Facility Name
Inca - Instituto Nacional Do Cancêr
City
Rio de Janeiro
Country
Brazil
Facility Name
Centro de Estudos de Hematologia E Oncologia Da Fmabc
City
Sao Paulo
Country
Brazil
Facility Name
Fundacao Pio XII - Hospital de Cancer de Barretos
City
Sao Paulo
Country
Brazil
Facility Name
Hospital Ac Camargo
City
Sao Paulo
Country
Brazil
Facility Name
Hospital Alemao Oswaldo Cruz
City
Sao Paulo
Country
Brazil
Facility Name
Hospital das Clínicas da Faculdade de Medicina da USP
City
Sao Paulo
Country
Brazil
Facility Name
Santa Casa de Misericórida de São Paulo
City
Sao Paulo
Country
Brazil
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
University Health Network, Princess Margaret Hospital
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Hospital Clinico Universidad Catolica de Chile
City
Santiago
Country
Chile
Facility Name
Hospital Del Salvador
City
Santiago
Country
Chile
Facility Name
Instituto Nacional Del Cancer
City
Santiago
Country
Chile
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
West China Hospital, Sichuan University
City
Chengdu
State/Province
Sichuan
Country
China
Facility Name
Zhejiang University First Hospital
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
Beijing Cancer Hospital
City
Beijing
Country
China
Facility Name
Cancer Institute & Cancer Hospital, CAMS&PUMC
City
Beijing
Country
China
Facility Name
Peking University Third Hospital
City
Beijing
Country
China
Facility Name
Cancer hospital, Fudan University
City
Shanghai
Country
China
Facility Name
Ruijin Hospital
City
Shanghai
Country
China
Facility Name
Tianjin Medical University Cancer Hospital and Institute
City
Tianjin
Country
China
Facility Name
Clinica Reina Sofia
City
Bogota
Country
Colombia
Facility Name
Hospital Pablo Tobon Uribe
City
Medellin
Country
Colombia
Facility Name
Hospital Universitario San Vicente de Paul
City
Medellin
Country
Colombia
Facility Name
Interni hematoonkoligicka klinika
City
Brno
Country
Czechia
Facility Name
Interni klinika - Oddeleni klin. hematologie Fakultni nemocnice Hradec Kralove
City
Hradec Kralove
Country
Czechia
Facility Name
Oddeleni klinicke hematologie, Fakultni nemocnice Kralovske Vinohrady
City
Praha
Country
Czechia
Facility Name
Vivantes Klinikum Neukölln Klinik für Innere Medizin Hämatologie und Onkologie
City
Berlin
Country
Germany
Facility Name
Vivantes Klinikum Spandau Klinik für Innere Medizin - Hämatologie, Onkologie und Gastroenterologie
City
Berlin
Country
Germany
Facility Name
Städt. Kliniken Frankfurt-Hoechst Med. Klinik II - Hämatologie und Onkologie
City
Frankfurt
Country
Germany
Facility Name
Tumorklinik SANAFONTIS Alpine GmbH
City
Freiburg
Country
Germany
Facility Name
Wilhelm-Anton-Hospital Goch gGmbH Klinik für Hämatologie und internistische Onkologie
City
Goch
Country
Germany
Facility Name
Klinikum Lippe-Lemgo Med. Klinik II - Hämatologie und Onkologie
City
Lemgo
Country
Germany
Facility Name
Johannes-Gutenberg-Universität Mainz III. Med. Klinik
City
Mainz
Country
Germany
Facility Name
Mutterhaus der Borromäerinnen Med. Klinik I
City
Trier
Country
Germany
Facility Name
Schwarzwald-Baar-Kliniken Innere Med. II
City
Villingen
Country
Germany
Facility Name
Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum, III. sz. Belgyogyaszati Klinika
City
Debrecen
Country
Hungary
Facility Name
Petz Aladár Kórház, II. Belgyógyászat
City
Győr
Country
Hungary
Facility Name
Kaposi Mor Megyei Korhaz, Belgyogyaszat
City
Kaposvar
Country
Hungary
Facility Name
Apollo Hospital and Research Foundation, Apollo Hospitals
City
Hyderabad 500033
State/Province
Andhra Pradesh
Country
India
Facility Name
Sir Ganga Ram Hospital
City
New Delhi- 110060
State/Province
Delhi
Country
India
Facility Name
Kidwai Memorial Institute of Oncology
City
Bangalore 560 029
State/Province
Karnataka
Country
India
Facility Name
Regional Cancer Centre, Medical Oncology
City
Thiruvananthapuram
State/Province
Kerala-695011
Country
India
Facility Name
Jehangir Hospital
City
Pune-411002
State/Province
Maharashtra
Country
India
Facility Name
Apollo Speciality Hospital, Chennai
City
Chennai-600035
State/Province
Tamil Nadu
Country
India
Facility Name
Netaji Subash Chanda Bose Cancer Research Institute
City
Kolkata- 700016
State/Province
West Bengal
Country
India
Facility Name
Rambam Medical Center-Hematology department
City
Haifa
Country
Israel
Facility Name
Hadassah Medical Center - Hematology department
City
Jerusalem
Country
Israel
Facility Name
Rabin Medical Center, Beilinson Campus
City
Petach Tiqva
Country
Israel
Facility Name
Sheba Medical Center
City
Ramat-Gan
Country
Israel
Facility Name
Kaplan Medical Center - Hematology Institute
City
Rechovot
Country
Israel
Facility Name
Azienda Ospedaliera Universitaria di Bologna Policlinico S.Orsola-Malpighi Dipartimento di Ematologia e Scienze Oncologiche "L. e A. Seragnoli"
City
Bologna
Country
Italy
Facility Name
Spedali Civili di Brescia
City
Brescia
Country
Italy
Facility Name
Dipartimento di Oncologia ed Ematologia Università di Modena e Reggio Emilia
City
Modena
Country
Italy
Facility Name
AZIENDA OSPEDALIERA UNIVERSITARIA POLICLINICO TOR VERGATA DIPARTIMENTO DI MEDICINA U.O.C. Ematologia
City
Roma
Country
Italy
Facility Name
Azienda Ospedaliera San Giovanni Battista "Molinette" Struttura Complessa Ematologia 2
City
Torino
Country
Italy
Facility Name
University Malaya Medical Centre
City
Kuala Lumpur
Country
Malaysia
Facility Name
Gleneagles Medical Centre
City
Pulau Pinang
Country
Malaysia
Facility Name
Hopital Du 20 Aout 1953
City
Casablanca
Country
Morocco
Facility Name
Centre D'oncologie Al Azhar
City
Rabat
Country
Morocco
Facility Name
Institut National D'oncologie
City
Rabat
Country
Morocco
Facility Name
National Kidney and Transplant Institute
City
Quezon City
Country
Philippines
Facility Name
St Lukes Medical Center
City
Quezon City
Country
Philippines
Facility Name
Szpital Morski im. PCK w Gdyni Gdynskie Centrum Onkologii Oddzial Chemioterapii
City
Gdynia
Country
Poland
Facility Name
Klinika Hematologii Uniwersytetu Medycznego w Lodzi
City
Lodz
Country
Poland
Facility Name
"Katedra i Klinika Hematologii i Chorob Rozrostowych Ukladu Krwiotworczego
City
Poznan
Country
Poland
Facility Name
Klinika Hematologii Nowotworow Krwi i Transplantacji Szpiku Akademii Medycznej we Wroclawiu
City
Wroclaw
Country
Poland
Facility Name
Hospital Sao Marcos
City
Braga
Country
Portugal
Facility Name
Hospitais da Universidade de Coimbra
City
Coimbra
Country
Portugal
Facility Name
Hospital de Santa Maria
City
Lisboa
Country
Portugal
Facility Name
Instituto Portugues de Oncologia
City
Porto
Country
Portugal
Facility Name
Spitalul Judetean de Urgenta "Dr. Constantin Opris", Hematologie
City
Baia Mare
Country
Romania
Facility Name
Institutul Clinic Fundeni, Hematologie
City
Bucuresti
Country
Romania
Facility Name
Spitalul Clinic Coltea, Clinica Hematologie
City
Bucuresti
Country
Romania
Facility Name
Spitalul Clinic Universitar de Urgenta Bucuresti, Hematologie
City
Bucuresti
Country
Romania
Facility Name
Spitalul Clinic Judetean de Urgenta "Sf. Spiridon" Iasi, Oncologie Medicala
City
Iasi
Country
Romania
Facility Name
Arkhangelsk Regional Clinical Hospital
City
Arkhangelsk
Country
Russian Federation
Facility Name
Belgorod Regional Oncology Center
City
Belgorod
Country
Russian Federation
Facility Name
Chelyabinsk Regional Oncology Center
City
Chelyabinsk
Country
Russian Federation
Facility Name
Sverdlovsk Regional Oncology Dispensary
City
Ekaterinburg
Country
Russian Federation
Facility Name
1st Republican Clinical Hospital of Udmurtia
City
Izhevsk
Country
Russian Federation
Facility Name
Cancer Research Center RAMS - N.N. Blokhin - Academy of Medical Science
City
Moscow
Country
Russian Federation
Facility Name
Hematology Scientific Center
City
Moscow
Country
Russian Federation
Facility Name
Moscow Regional Clinical Research Institute
City
Moscow
Country
Russian Federation
Facility Name
S.P. Botkin Moscow City Clinical Hospital
City
Moscow
Country
Russian Federation
Facility Name
Nizhniy Novgorod Region Clinical Hospital
City
Nizhniy Novgorod
Country
Russian Federation
Facility Name
Medical Scientific Radiology - Center
City
Obninsk
Country
Russian Federation
Facility Name
Omsk Regional Oncology Dispensary
City
Omsk
Country
Russian Federation
Facility Name
Medical Sanitary Unit # 1
City
Perm
Country
Russian Federation
Facility Name
Republikan Hospital named after V.A/ Baranov
City
Petrozavodsk
Country
Russian Federation
Facility Name
Rostov Research Institute of Oncology
City
Rostov-on-Don
Country
Russian Federation
Facility Name
City Clinical Oncology Dispensary
City
St Petersburg
Country
Russian Federation
Facility Name
Central Res. Inst. of Roentgen-Radiology
City
St-Petersburg
Country
Russian Federation
Facility Name
Pavlov State Medical Univercity
City
St-Petersburg
Country
Russian Federation
Facility Name
Leningrad Region Clinical Hospital
City
St. Petersburg
Country
Russian Federation
Facility Name
St.-Petersburg Clinical Research Institute of Hematology and Transfusiology
City
St. Petersburg
Country
Russian Federation
Facility Name
National Cancer Centre
City
Singapore
Country
Singapore
Facility Name
Singapore General Hospital - Hematology
City
Singapore
Country
Singapore
Facility Name
Chris Hani Baragwanath Hospital
City
Johannesburg
State/Province
Gauteng
Country
South Africa
Facility Name
Medical Oncology Center of Rosebank
City
Johannesburg
State/Province
Gauteng
Country
South Africa
Facility Name
University of the Witwatersrand Oncology
City
Johannesburg
State/Province
Gauteng
Country
South Africa
Facility Name
Pretoria Academic Hospital-Dr. Savage Road, 3rd Floor Radiotherapy Building, Prinshof
City
Pretoria
State/Province
Gauteng
Country
South Africa
Facility Name
Dr AI Pirjol & Dr WM Szpak Inc.
City
Durban
State/Province
Kwazulu Natal
Country
South Africa
Facility Name
Hospital Universitario Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
Country
Spain
Facility Name
Hospital Clinic I Provincial de Barcelona
City
Barcelona
Country
Spain
Facility Name
Hospital de la Princesa
City
Madrid
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
Country
Spain
Facility Name
Hospital Clinico Universitario Salamanca
City
Salamanca
Country
Spain
Facility Name
Chang Gung Memorial Hospital, Linkou
City
Tao-Yuan
Country
Taiwan
Facility Name
King Chulalongkorn Memorial Hospital
City
Bangkok
Country
Thailand
Facility Name
Ramathibodi Hospital
City
Bangkok
Country
Thailand
Facility Name
Siriraj Hospital-Hematology Unit
City
Bangkok
Country
Thailand
Facility Name
Maharaj Nakorn Chiang Mai hospital - Faculty of Medicine
City
Chiang Mai
Country
Thailand
Facility Name
Hôpital Farhat Hached
City
Sousse
Country
Tunisia
Facility Name
Centre National de Greffe de Moelle osseuse
City
Tunis
Country
Tunisia
Facility Name
Hôpital Aziza Othmana
City
Tunis
Country
Tunisia
Facility Name
Institut Salah Azaiz
City
Tunis
Country
Tunisia
Facility Name
Hacettepe University Medical Faculty
City
Ankara
Country
Turkey
Facility Name
Dokuz Eylul University Med. Fac.
City
Izmir
Country
Turkey
Facility Name
Cherkassy Regional Oncology Center, Dept. of Hematology
City
Cherkassy
Country
Ukraine
Facility Name
Dnepropetrovsk City Clinical Hospital #4, Regional Hematology Center
City
Dnepropetrovsk
Country
Ukraine
Facility Name
Institute of Urgent and Recovery Surgery named after V.K.Gusaka of AMS of Ukraine, Haematology Dept.
City
Donetsk
Country
Ukraine
Facility Name
Khmelnitskiy Regional Hospital, Hematology Department
City
Khmelnitsky
Country
Ukraine
Facility Name
National Cancer Institute, Department of chemotherapy of hemoblastosis
City
Kiev
Country
Ukraine
Facility Name
Institute of Blood Pathology and Transfusion Medicine, Lviv Clinical Hospital #5, Hematology Dept.
City
Lviv
Country
Ukraine
Facility Name
Crimean Republic Clinical Oncology Dispensary, Haematology Department
City
Simferopol
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
30348538
Citation
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.
Results Reference
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PubMed Identifier
28583031
Citation
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.
Results Reference
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PubMed Identifier
28183846
Citation
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.
Results Reference
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PubMed Identifier
25738670
Citation
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.
Results Reference
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Learn more about this trial

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

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