Non Hodgkin Lymphoma Clinical Trial

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

Summary

This was a randomized, double-blind, active-controlled, multiple-dose, clinical similarity study to evaluate the efficacy, pharmacokinetics, pharmacodynamics, safety, tolerability and immunogenicity of ABP 798 compared with rituximab in subjects with grade 1, 2, or 3a follicular B-cell NHL and low tumor burden.

Subjects were randomized in a 1:1 ratio to receive a 375 mg/m^2 intravenous infusion of either ABP 798 or rituximab once weekly for 4 weeks followed by dosing at weeks 12 and 20.

View Eligibility Criteria

Eligibility 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)

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 3

Estimated Enrollment:

256

Study ID:

NCT02747043

Recruitment Status:

Completed

Sponsor:

Amgen

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There are 96 Locations for this study

See Locations Near You

Research Site
Encinitas California, 92024, United States
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Mount Sterling Kentucky, 40353, United States
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Billings Montana, 59102, United States
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Zanesville Ohio, 43701, United States
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Roanoke Virginia, 24014, United States
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Gosford New South Wales, 2250, Australia
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Frankston Victoria, 3199, Australia
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Perth Western Australia, 6000, Australia
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Plovdiv , 4002, Bulgaria
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Stara Zagora , 6000, Bulgaria
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Windsor Ontario, N8W 2, Canada
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Medellin Antioquia, 05003, Colombia
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Bogota Cundinamarca, 11011, Colombia
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Praha 5 Praha, 150 0, Czechia
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Ostrava - Poruba Severomoravsky KRAJ, 708 5, Czechia
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Bordeaux Cedex Aquitaine, 33077, France
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Clermont Ferrand Auvergne, 63050, France
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Cesson-Sevigne Bretagne, 35576, France
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Boulogne sur Mer NORD Pas-de-calais, 62321, France
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La Rochelle Poitou-charentes, 17000, France
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Poitiers Cedex Poitou-charentes, 86021, France
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Batumi , 6000, Georgia
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Tbilisi , 0112, Georgia
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Tbilisi , 0160, Georgia
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Tbilisi , 0186, Georgia
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Freiburg Baden-wuerttemberg, 79110, Germany
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Augsburg Bayern, 86156, Germany
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Würzburg Bayern, 97080, Germany
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Kassel Hessen, 34125, Germany
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Münster Nordrhein-westfalen, 48149, Germany
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Leipzig Sachsen, 04103, Germany
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Flensburg Schleswig-holstein, 24939, Germany
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Athens Attica, 11525, Greece
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Athens Attica, 11527, Greece
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Patra Peloponnese, 26504, Greece
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Surat Gujarat, 39501, India
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Vadodara Gujarat, 39000, India
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Bangalore Karnataka, 56006, India
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Mangalore Karnataka, 57500, India
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Nashik Maharashtra, 42200, India
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Pune Maharashtra, 411 0, India
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Bikaner Rajasthan, 334 0, India
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Be'er Ya'akov Rehoboth, 70300, Israel
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San Giovanni Rotondo Foggia, 71013, Italy
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Bergamo Lombardia, 24127, Italy
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Pesaro Pesaro E Urbino, 61100, Italy
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Aviano Pordenone, 33081, Italy
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Candiolo Torino, 10060, Italy
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Brescia , 25123, Italy
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Milano , 20141, Italy
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Milano , 20153, Italy
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Padova , 35128, Italy
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Parma , 43126, Italy
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Ravenna , 48100, Italy
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Rimini , 47900, Italy
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Terni , 05100, Italy
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Chiba-city Chiba, 260-8, Japan
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Fukuoka-shi Fukuoka, 811-1, Japan
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Maebashi-city Gunma, 371-8, Japan
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Kobe-city Hyogo, 650-0, Japan
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Tsu MIE, 514-8, Japan
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Utsunomiya City Tochigi, 320-0, Japan
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Tachikawa-city Tokyo, 190-0, Japan
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Tokyo , 150-8, Japan
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Seoul Gyeonggi-do, 135-7, Korea, Republic of
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Seoul Gyeonggi-do, 158-7, Korea, Republic of
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Busan Gyeongsangnam-do, 48108, Korea, Republic of
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Jinju-si Gyeongsangnam-do, 52727, Korea, Republic of
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Daegu , 41931, Korea, Republic of
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Daegu , 42415, Korea, Republic of
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Seoul , 03080, Korea, Republic of
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Seoul , 03181, Korea, Republic of
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Seoul , 03722, Korea, Republic of
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Ulsan , 44033, Korea, Republic of
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Mexico City Distrito Federal, 01120, Mexico
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Chihuahua , 31203, Mexico
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Legnica Dolnoslaskie, 59-22, Poland
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Toruń Kujawsko-pomorskie, 87-10, Poland
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Kraków Malopolskie, 31-82, Poland
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Gdańsk Pomorskie, 80-21, Poland
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Targu-Mures Mures, 54004, Romania
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Targu-Mures Mures, 54013, Romania
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Timisoara Timis, 30002, Romania
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Bucuresti , 03017, Romania
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Sabadell Barcelona, 08208, Spain
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Córdoba Cordoba, 14004, Spain
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Majadahonda Madrid, 28222, Spain
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La Laguna Tenerife Santa CRUZ DE Tenerife, 38320, Spain
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Barcelona , 08003, Spain
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Caceres , 10003, Spain
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Cadiz , 11009, Spain
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Madrid , 28046, Spain
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Salamanca , 37007, Spain
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Kyiv Kiev, 03115, Ukraine
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Kyiv Kiev, 04112, Ukraine
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Uzhgorod Transcarpathia, 88014, Ukraine
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Chernivtsi , 58013, Ukraine
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Dnipropetrovsk , 49055, Ukraine

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 3

Estimated Enrollment:

256

Study ID:

NCT02747043

Recruitment Status:

Completed

Sponsor:


Amgen

How clear is this clinincal trial information?

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