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Study to Assess if ABP798 is Safe & Effective in Treating Non Hodgkin Lymphoma Compared to Rituximab (JASMINE)

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ClinicalTrials.gov Identifier: NCT02747043
Recruitment Status : Recruiting
First Posted : April 21, 2016
Last Update Posted : December 7, 2018
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief Summary:

This trial is designed to determine what effects the human body has on the

investigational medicine, ABP 798, and what effects the body has on the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, rituximab, in patients with CD 20 positive B-cell non Hodgkin lymphoma.

This study will assess if the investigational medicine is safe and effective in treating CD 20 positive B-cell non Hodgkin lymphoma.


Condition or disease Intervention/treatment Phase
Lymphoma, Non-Hodgkin Drug: ABP 798 Drug: Rituximab Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind Study Evaluating the Efficacy, Safety and Immunogenicity of ABP 798 Compared With Rituximab in Subjects With CD20 Positive B-Cell Non-Hodgkin Lymphoma (NHL)
Actual Study Start Date : May 25, 2016
Estimated Primary Completion Date : June 16, 2019
Estimated Study Completion Date : June 16, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab

Arm Intervention/treatment
Experimental: ABP 798
Concentrate for solution for infusion, ABP 798 at a dose of 375 mg/m2 administered as an intravenous (IV) infusion once weekly for 4 weeks followed by dosing at weeks 12 and 20
Drug: ABP 798
375 mg/m2, IV (in the vein)

Active Comparator: Rituximab
Concentrate for solution for infusion, Rituximab at a dose of 375 mg/m2 administered as an IV infusion once weekly for 4 weeks followed by dosing at weeks 12 and 20
Drug: Rituximab
375 mg/m2, IV (in the vein)
Other Name: Rituxan




Primary Outcome Measures :
  1. Risk difference (RD) of objective response rate (ORR) [ Time Frame: Week 28 ]
  2. Risk difference (RD) of overall response rate (ORR) [ Time Frame: Week 28 ]

Secondary Outcome Measures :
  1. Risk difference of ORR [ Time Frame: Week 12 ]
  2. Percent of subjects with complete depletion of CD19 cell count and total Immunoglobin G (IgG) and IgM antibody levels [ Time Frame: Baseline to study day 8 ]
  3. Subject incidence of treatment-emergent AEs and serious adverse events [ Time Frame: Up to Week 28 ]
    Clinical significant changes in laboratory values and vital signs will be reported as AEs

  4. Incidence of anti-drug antibodies [ Time Frame: Up to Week 28 ]
  5. On study progression-free survival [ Time Frame: Up to Week 28 ]
  6. On study overall survival [ Time Frame: Up to Week 28 ]
  7. Geometric mean ratio (GMR) of test (ABP 798)-to-reference (rituximab) [ Time Frame: Predose and after end of infusion at week 12 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females 18 years of age and older
  • Histological confirmed (by lymph node or extranodal region biopsy), Grade 1, 2, or 3a follicular B-cell NHL expressing CD20 within 12 months before randomization
  • Stage 2, 3, or 4 (per Cotswold's Modification of Ann Arbor Staging System) with measurable disease (per International Working Group)

    • subjects must have a baseline scan (computed tomography [CT]) of the neck (if palpable lymph node > 1.0 cm), chest, abdomen, and pelvis to assess disease burden within 6 weeks before randomization
    • subjects must have had a baseline bone marrow biopsy within 12 months before randomization. Previously confirmed positive bone marrow involvement does not need to be repeated for purposes of screening.
  • Low tumor burden based on the Groupe d'Etudes des Lymphomes Folliculaires (GELF) criteria

    • largest nodal or extranodal mass ≤ 7 cm
    • no more than 3 nodal sites with diameter > 3 cm
    • no splenomegaly > 16cm by CT scan and no symptomatic splenomegaly
    • no significant pleural or peritoneal serous effusions by CT
    • lactate dehydrogenase ≤ upper limit of normal (ULN)
    • no B symptoms (night sweats, fever [temperature > 38°C], weight loss > 10% in the previous 6 months)

Exclusion Criteria:

  • Diffuse large cell component and/or Grade 3b follicular NHL
  • History or known presence of central nervous system metastases
  • Malignancy other than NHL within 5 years (except treated in-situ cervical cancer, or squamous or basal cell carcinoma of the skin)
  • Recent infection requiring a course of systemic anti-infective agents that was completed ≤ 7 days before randomization (with the exception of uncomplicated urinary tract infection)
  • Other investigational procedures that can impact the study data, results, or patient safety while participating in this study are excluded; participation in observational studies is allowed.
  • Subject is currently enrolled in or has not yet completed at least 30 days or 5 half-lives (whichever is longer) since ending other investigational device or drug study(s), including vaccines, or subject is receiving other investigational agent(s)
  • Previous use of either commercially available or investigational chemotherapy, biological, or immunological therapy for NHL (including rituximab or biosimilar rituximab, or other anti-CD20 treatments)
  • Systemic corticosteroid use within 3 months before randomization (inhaled are allowable)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02747043


Contacts
Contact: Amgen Call Center 866-572-6436 medinfo@amgen.com

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Locations
United States, California
Research Site Recruiting
Encinitas, California, United States, 92024-1332
Research Site Recruiting
Vallejo, California, United States, 94589
United States, Kentucky
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Mount Sterling, Kentucky, United States, 40353
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Paducah, Kentucky, United States, 42003
United States, Montana
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Billings, Montana, United States, 59102
United States, Ohio
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Zanesville, Ohio, United States, 43701
United States, Oklahoma
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Oklahoma City, Oklahoma, United States, 73109
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Oklahoma City, Oklahoma, United States, 73142
United States, Virginia
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Roanoke, Virginia, United States, 24014
Australia, New South Wales
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Gosford, New South Wales, Australia, 2250
Australia, Victoria
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Frankston, Victoria, Australia, 3199
Australia, Western Australia
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Perth, Western Australia, Australia, 6000
Bulgaria
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Sofia, Sofiya, Bulgaria, 1407
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Plovdiv, Bulgaria, 4002
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Stara Zagora, Bulgaria, 6000
Canada, Ontario
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Windsor, Ontario, Canada, N8W 2X3
Colombia
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Medellin, Antioquia, Colombia, 050034
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Bogota, Cundinamarca, Colombia, 110111
Czechia
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Praha 5, Praha, Czechia, 150 06
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Ostrava - Poruba, Severomoravsky KRAJ, Czechia, 708 52
France
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Bordeaux Cedex, Aquitaine, France, 33077
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Clermont Ferrand, Auvergne, France, 63050
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Brest Cedex, Bretagne, France, 29609
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Cesson-Sevigne, Bretagne, France, 35576
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Corbeil Essonnes, Ile-de-france, France, 91106
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Boulogne sur Mer, NORD Pas-de-calais, France, 62321
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La Rochelle, Poitou-charentes, France, 17000
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Poitiers Cedex, Poitou-charentes, France, 86021
Georgia
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Batumi, Georgia, 6000
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Tbilisi, Georgia, 0112
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Tbilisi, Georgia, 0160
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Tbilisi, Georgia, 0186
Germany
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Freiburg, Baden-wuerttemberg, Germany, 79110
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Aschaffenburg, Bayern, Germany, 63739
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Augsburg, Bayern, Germany, 86156
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Würzburg, Bayern, Germany, 97080
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Kassel, Hessen, Germany, 34125
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Rostock, Mecklenburg-vorpommern, Germany, 18057
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Essen, Nordrhein-westfalen, Germany, 45147
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Münster, Nordrhein-westfalen, Germany, 48149
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Leipzig, Sachsen, Germany, 04103
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Flensburg, Schleswig-holstein, Germany, 24939
Greece
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Athens, Attica, Greece, 11525
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Athens, Attica, Greece, 11527
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Athens, Attica, Greece, 12462
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Ioannina, Epirus, Greece, 45500
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Patra, Peloponnese, Greece, 26504
India
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Vijayawada, Andhra Pradesh, India, 520002
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New Delhi, Delhi, India, 110060
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Ahmedabad, Gujarat, India, 380009
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Surat, Gujarat, India, 395010
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Vadodara, Gujarat, India, 390001
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Bangalore, Karnataka, India, 560068
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Mangalore, Karnataka, India, 575001
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Nashik, Maharashtra, India, 422004
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Pune, Maharashtra, India, 411 001
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Bikaner, Rajasthan, India, 334 003
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Madurai, Tamil NADU, India, 625107
Israel
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Be'er Ya'akov, Rehoboth, Israel, 7030000
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Haifa, Israel, 34362
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Nahariya, Israel
Italy
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San Fermo della Battaglia, Como, Italy, 22020
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San Giovanni Rotondo, Foggia, Italy, 71013
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Bergamo, Lombardia, Italy, 24127
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Pesaro, Pesaro E Urbino, Italy, 61100
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Aviano, Pordenone, Italy, 33081
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Candiolo, Torino, Italy, 10060
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Brescia, Italy, 25123
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Lecce, Italy, 73100
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Milano, Italy, 20141
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Milano, Italy, 20153
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Padova, Italy, 35128
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Parma, Italy, 43126
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Piacenza, Italy, 29100
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Potenza, Italy, 85100
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Ravenna, Italy, 48100
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Rimini, Italy, 47900
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Terni, Italy, 05100
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Verona, Italy, 37134
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Vimercate, Italy, 20871
Japan
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Chiba-city, Chiba, Japan, 260-8717
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Fukuoka-shi, Fukuoka, Japan, 811-1395
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Maebashi-city, Gunma, Japan, 371-8511
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Kobe-city, Hyogo, Japan, 650-0047
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Tsu, MIE, Japan, 514-8507
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Utsunomiya City, Tochigi, Japan, 320-0834
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Tachikawa-city, Tokyo, Japan, 190-0014
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Tokyo, Japan, 150-8935
Korea, Republic of
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Seoul, Gyeonggi-do, Korea, Republic of, 135-710
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Seoul, Gyeonggi-do, Korea, Republic of, 158-710
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Busan, Gyeongsangnam-do, Korea, Republic of, 48108
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Jinju-si, Gyeongsangnam-do, Korea, Republic of, 52727
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Daegu, Korea, Republic of, 41931
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Daegu, Korea, Republic of, 42415
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Seoul, Korea, Republic of, 03080
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Seoul, Korea, Republic of, 03181
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Seoul, Korea, Republic of, 03722
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Ulsan, Korea, Republic of, 44033
Mexico
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Mexico City, Distrito Federal, Mexico, 01120
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Cuernavaca, Morelos, Mexico, 62290
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Monterrey, Nuevo LEON, Mexico, 64000
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Monterrey, Nuevo LEON, Mexico, 64460
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Boca del Rio, Veracruz, Mexico, 94290
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Aguascalientes, Mexico, 20010
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Chihuahua, Mexico, 31203
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Veracruz, Mexico, 91900
Poland
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Legnica, Dolnoslaskie, Poland, 59-220
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Toruń, Kujawsko-pomorskie, Poland, 87-100
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Kraków, Malopolskie, Poland, 31-826
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Gdańsk, Pomorskie, Poland, 80-219
Romania
Research Site Completed
Targu-Mures, Mures, Romania, 540042
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Targu-Mures, Mures, Romania, 540136
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Timisoara, Timis, Romania, 300021
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Brasov, Romania, 500152
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Bucuresti, Romania, 020125
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Bucuresti, Romania, 022328
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Bucuresti, Romania, 030171
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Bucuresti, Romania, 050098
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Bucuresti, Romania, 50098
Spain
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Sabadell, Barcelona, Spain, 08208
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Córdoba, Cordoba, Spain, 14004
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Majadahonda, Madrid, Spain, 28222
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Pamplona, Navarra, Spain, 31008
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La Laguna Tenerife, Santa CRUZ DE Tenerife, Spain, 38320
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Barcelona, Spain, 08003
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Caceres, Spain, 10003
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Cadiz, Spain, 11009
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Madrid, Spain, 28046
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Salamanca, Spain, 37007
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Sevilla, Spain, 41009
Ukraine
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Kyiv, Kiev, Ukraine, 03115
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Kyiv, Kiev, Ukraine, 04112
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Uzhgorod, Transcarpathia, Ukraine, 88014
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Chernivtsi, Ukraine, 58013
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Dnipropetrovsk, Ukraine, 49055
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02747043     History of Changes
Other Study ID Numbers: 20130109
First Posted: April 21, 2016    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.
URL: https://www.amgen.com/datasharing

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents