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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02747043
Recruitment Status : Active, not recruiting
First Posted : April 21, 2016
Last Update Posted : January 10, 2019
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

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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 : July 17, 2019
Estimated Study Completion Date : July 17, 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 ]


Information from the National Library of Medicine

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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


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

Additional Information:
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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: January 10, 2019
Last Verified: January 2019
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:
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Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents