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| ID | Type | Description | Link |
|---|---|---|---|
| 26866138-LYM-3002CTIL | Other Identifier | Israel | |
| 2007-005669-37 | EudraCT Number | ||
| 0970313683 | Registry Identifier | TCTIN | |
| U1111-1195-3827 | Other Identifier | WHO |
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| Name | Class |
|---|---|
| Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| R-CHOP | Active Comparator | Rituximab 375 mg/m^2, Cyclophosphamide 750 mg/m^2, Doxorubicin 50 mg/m^2, Vincristine 1.4 mg/m^2, and Prednisone 100 mg/m^2 |
|
| VcR-CAP | Experimental | Rituximab 375 mg/m^2, Cyclophosphamide 750 mg/m^2, Doxorubicin 50 mg/m^2, VELCADE 1.3 mg/m^2, and Prednisone 100 mg/m^2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rituximab 375 mg/m^2 | Drug | Intravenous rituximab 375 mg/m^2 on Day 1 of a 21-day (3 week) cycle for 6 cycles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | PFS was defined as the interval between the date of randomization and the date of progressive disease (PD) or death, whichever occurred first. PD was based on the assessment of an Independent Review Committee. | Median duration of follow-up of 40 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Median duration of follow-up of 40 months |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director Clinical Science | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Francis Hosptial and Medical Center | Hartford | Connecticut | 06105 | United States | ||
| Center for Cancer Care at Goshen Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30348538 | Derived | 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. | |
| 28583031 |
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A total of 487 participants were randomized from 128 centers in 28 countries from 22 May 2008 to 17 June 2017; 244 to the R-CHOP treatment group and 243 to the VcR-CAP treatment group. Of the 487 randomized participants, 242 in the R-CHOP group and 240 in the VcR-CAP group received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles. Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles Doxorubicin: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles Prednisone: Prednisone orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles Vincristine: Vincristine intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 8, 2014 | Jun 14, 2018 |
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| Cyclophosphamide 750 mg/m^2 | Drug | Intravenous cyclophosphamide 750 mg/m^2 on Day 1 of a 21-day (3 week) cycle for 6 cycles |
|
| Doxorubicin 50 mg/m^2 | Drug | Intravenous doxorubicin 50 mg/m^2 on Day 1 of a 21-day (3 week) cycle for 6 cycles |
|
| VELCADE 1.3 mg/m^2 | Drug | Intravenous VELCADE 1.3 mg/m^2 on Days 1,4,8, and 11of a 21-day (3 week) cycle for 6 cycles |
|
| Prednisone 100 mg/m^2 | Drug | Oral prednisone 100 mg/m^2 on Day 1 to Day 5 of a 21-day (3 week) cycle for 6 cycles |
|
| Vincristine 1.4 mg/m^2 | Drug | Intravenous vincristine 1.4 mg/m^2 on Day 1of a 21-day (3 week) cycle for 6 cycles. Maximum of 2 mg. Participants could receive 8 cycles if a response was initially documented at the Cycle 6 assessment. |
|
| 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). | Median duration of follow-up of 40 months |
| 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. | : Median duration of follow-up of 40 months |
| 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. | Median duration of follow-up of 40 months |
| 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. | Median duration of follow-up of 40 months |
| 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. | Median duration of follow-up of 40 months |
| 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. | Median duration of follow-up of 40 months |
| 18-Month Survival | 18-month survival was defined as the estimated probability of survival at 18 months (Kaplan-Meier estimate). | Up to month 18 from the time of randomization |
| 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. | Up to 107.4 months |
| 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. | Up to 107.4 months |
| Goshen |
| Indiana |
| 46526 |
| United States |
| Sinai Hospital | Baltimore | Maryland | 21215 | United States |
| Capitol Comp. Cancer Center | Jefferson City | Missouri | 65109 | United States |
| Nebraska Cancer Specialists | Omaha | Nebraska | 68114 | United States |
| Hematology-Oncology Associates of Northern NJ | Morristown | New Jersey | 07960 | United States |
| Legacy Pharma Research | Bismarck | North Dakota | 58501 | United States |
| Division of Hematology and Oncology Vanderbilt University | Nashville | Tennessee | 37232 | United States |
| Cancer Outreach Associates, PC | Abingdon | Virginia | 24211 | 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 | 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 |
| Derived |
| Robak T, Huang H, Jin J, Zhu J, Liu T, Samoilova O, Pylypenko H, Verhoef G, Siritanaratkul N, Osmanov E, Pereira J, Mayer J, Hong X, Okamoto R, Pei L, Rooney B, van de Velde H, Cavalli F. Association between bortezomib dose intensity and overall survival in mantle cell lymphoma patients on frontline VR-CAP in the phase 3 LYM-3002 study. Leuk Lymphoma. 2019 Jan;60(1):172-179. doi: 10.1080/10428194.2017.1321750. Epub 2017 Jun 5. |
| 28183846 | Derived | Verhoef G, Robak T, Huang H, Pylypenko H, Siritanaratkul N, Pereira J, Drach J, Mayer J, Okamoto R, Pei L, Rooney B, Cakana A, van de Velde H, Cavalli F. Association between quality of response and outcomes in patients with newly diagnosed mantle cell lymphoma receiving VR-CAP versus R-CHOP in the phase 3 LYM-3002 study. Haematologica. 2017 May;102(5):895-902. doi: 10.3324/haematol.2016.152496. Epub 2017 Feb 9. |
| 25738670 | Derived | Robak T, Huang H, Jin J, Zhu J, Liu T, Samoilova O, Pylypenko H, Verhoef G, Siritanaratkul N, Osmanov E, Alexeeva J, Pereira J, Drach J, Mayer J, Hong X, Okamoto R, Pei L, Rooney B, van de Velde H, Cavalli F; LYM-3002 Investigators. Bortezomib-based therapy for newly diagnosed mantle-cell lymphoma. N Engl J Med. 2015 Mar 5;372(10):944-53. doi: 10.1056/NEJMoa1412096. |
| FG001 | 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 Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles. Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles Doxorubicin: Intravenous on Day of a 21 day (3 week) cycle for 6 cycles VELCADE: VELCADE intravenous on Days 1,4,8, and 11 of a 21 day (3 week) cycle for 6 cycles Prednisone: Prednisone orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles. |
| COMPLETED | Completed participants are the participants who completed the treatment. |
|
| NOT COMPLETED |
|
|
The population consisted of all randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles. Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles Doxorubicin: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles Prednisone: Prednisone orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles Vincristine: Vincristine intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles. |
| BG001 | 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 Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles. Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles Doxorubicin: Intravenous on Day of a 21 day (3 week) cycle for 6 cycles VELCADE: VELCADE intravenous on Days 1,4,8, and 11 of a 21 day (3 week) cycle for 6 cycles Prednisone: Prednisone orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The population consisted of all randomized participants. | Posted | Median | 95% Confidence Interval | Days | Median duration of follow-up of 40 months |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The population consisted of all randomized participants. | Posted | Median | 95% Confidence Interval | Days | Median duration of follow-up of 40 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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). | The response-evaluable population was defined as all participants who received at least 1 dose of study drug, had >= 1 measurable tumor mass (>1.5 cm in the longest dimension and >1.0 cm in the short axis) at baseline and had at least 1 post-baseline tumor assessment by Independent Review Committee, before any subsequent anti-lymphoma treatment. | Posted | Median | 95% Confidence Interval | Days | Median duration of follow-up of 40 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The population consisted of all randomized participants. | Posted | Median | 95% Confidence Interval | Days | : Median duration of follow-up of 40 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | All randomized participants who received at least 1 dose of study medication. | Posted | Median | 95% Confidence Interval | Days | Median duration of follow-up of 40 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The response-evaluable population was defined as all participants who received >= 1 dose of study drug, had at least 1 measurable tumor mass (>1.5 cm in the longest dimension and >1.0 cm in the short axis) at baseline and had at least 1 post-baseline tumor assessment by Independent Review Committee, before any subsequent anti-lymphoma treatment. | Posted | Number | Participants | Median duration of follow-up of 40 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The response-evaluable population was defined as all participants who received >= 1 dose of study drug, had at least 1 measurable tumor mass (>1.5 cm in the longest dimension and >1.0 cm in the short axis) at baseline and had at least 1 post-baseline tumor assessment by Independent Review Committee, before any subsequent anti-lymphoma treatment. | Posted | Number | Participants | Median duration of follow-up of 40 months |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The population consisted of all randomized participants. | Posted | Median | 95% Confidence Interval | Days | Median duration of follow-up of 40 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 18-Month Survival | 18-month survival was defined as the estimated probability of survival at 18 months (Kaplan-Meier estimate). | The population consisted of all randomized participants. | Posted | Mean | 95% Confidence Interval | Percentage of Participants | Up to month 18 from the time of randomization |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The population consisted of all randomized participants. | Posted | Median | 95% Confidence Interval | Days | Up to 107.4 months |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | The safety population was defined as all randomized participants who received at least 1 dose of study medication. | Posted | Number | Participants | Up to 107.4 months |
|
Up to 107.4 months
The safety population was defined as all randomized participants who received at least 1 dose of study medication.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles. Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles Doxorubicin: Intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles Prednisone: Prednisone orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles Vincristine: Vincristine intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles. | 72 | 242 | 187 | 242 | ||
| EG001 | 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 Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles. Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles Doxorubicin: Intravenous on Day of a 21 day (3 week) cycle for 6 cycles VELCADE: VELCADE intravenous on Days 1,4,8, and 11 of a 21 day (3 week) cycle for 6 cycles Prednisone: Prednisone orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles. | 91 | 240 | 185 | 240 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Bone marrow failure | Blood and lymphatic system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Pneumonia streptococcal | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Abscess neck | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Candidiasis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Hepatitis B | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Klebsiella sepsis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Nosocomial infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Parotitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Pneumonia cytomegaloviral | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Postoperative abscess | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Pulmonary mycosis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Salmonellosis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Bacterial sepsis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Endocarditis bacterial | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Oral fungal infection | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Oropharyngeal candidiasis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Peritonsillar abscess | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Rectal abscess | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Tracheobronchitis | Infections and infestations | MedDRA 16.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Tonsillar haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Acute phase reaction | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Cardiac death | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Abdominal adhesions | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Ileus paralytic | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Anal fissure | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Periproctitis | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Left ventricular dysfunction | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Cardiogenic shock | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Supraventricular extrasystoles | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Acute left ventricular failure | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Cardiopulmonary failure | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Left ventricular failure | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Poor venous access | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Venous thrombosis | Vascular disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Autonomic neuropathy | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Encephalitis | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Peripheral sensorimotor neuropathy | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Fluid retention | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Compression fracture | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Traumatic lung injury | Injury, poisoning and procedural complications | MedDRA 16.0 | Systematic Assessment |
| |
| Soft tissue necrosis | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | Systematic Assessment | This serious adverse event occurred during long term follow-up period |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 16.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 16.0 | Systematic Assessment |
|
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Feb 3, 2014 | Jun 14, 2018 | Prot_001.pdf |
| ID | Term |
|---|---|
| D020522 | Lymphoma, Mantle-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069283 | Rituximab |
| D003520 | Cyclophosphamide |
| D004317 | Doxorubicin |
| D000069286 | Bortezomib |
| D011241 | Prednisone |
| D014750 | Vincristine |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
| D001896 | Boron Compounds |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
Not provided
Not provided
| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Poland |
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| Czech Republic |
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| Spain |
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| Hungary |
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| Romania |
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| Austria |
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| Italy |
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| Germany |
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| Portugal |
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| France |
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| Canada |
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| United States |
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| Russia |
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| China |
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| Ukraine |
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| Brazil |
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| Thailand |
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| Japan |
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| India |
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| Israel |
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| Tunisia |
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| Turkey |
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| Colombia |
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| Korea, Republic Of |
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| Chile |
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| Singapore |
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| Taiwan, Province Of China |
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| 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 Rituximab: Rituximab intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles. Cyclophosphamide: Cyclophosphamide intravenous on Day 1 of a 21 day (3 week) cycle for 6 cycles Doxorubicin: Intravenous on Day of a 21 day (3 week) cycle for 6 cycles VELCADE: VELCADE intravenous on Days 1,4,8, and 11 of a 21 day (3 week) cycle for 6 cycles Prednisone: Prednisone orally on Day 1 to Day 5 of a 21 day (3 week) cycle for 6 cycles. |
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