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.
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)
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There are 96 Locations for this study
Encinitas California, 92024, United States
Mount Sterling Kentucky, 40353, United States
Billings Montana, 59102, United States
Zanesville Ohio, 43701, United States
Roanoke Virginia, 24014, United States
Gosford New South Wales, 2250, Australia
Frankston Victoria, 3199, Australia
Perth Western Australia, 6000, Australia
Plovdiv , 4002, Bulgaria
Stara Zagora , 6000, Bulgaria
Windsor Ontario, N8W 2, Canada
Medellin Antioquia, 05003, Colombia
Bogota Cundinamarca, 11011, Colombia
Praha 5 Praha, 150 0, Czechia
Ostrava - Poruba Severomoravsky KRAJ, 708 5, Czechia
Bordeaux Cedex Aquitaine, 33077, France
Clermont Ferrand Auvergne, 63050, France
Cesson-Sevigne Bretagne, 35576, France
Boulogne sur Mer NORD Pas-de-calais, 62321, France
La Rochelle Poitou-charentes, 17000, France
Poitiers Cedex Poitou-charentes, 86021, France
Batumi , 6000, Georgia
Tbilisi , 0112, Georgia
Tbilisi , 0160, Georgia
Tbilisi , 0186, Georgia
Freiburg Baden-wuerttemberg, 79110, Germany
Augsburg Bayern, 86156, Germany
Würzburg Bayern, 97080, Germany
Kassel Hessen, 34125, Germany
Münster Nordrhein-westfalen, 48149, Germany
Leipzig Sachsen, 04103, Germany
Flensburg Schleswig-holstein, 24939, Germany
Athens Attica, 11525, Greece
Athens Attica, 11527, Greece
Patra Peloponnese, 26504, Greece
Surat Gujarat, 39501, India
Vadodara Gujarat, 39000, India
Bangalore Karnataka, 56006, India
Mangalore Karnataka, 57500, India
Nashik Maharashtra, 42200, India
Pune Maharashtra, 411 0, India
Bikaner Rajasthan, 334 0, India
Be'er Ya'akov Rehoboth, 70300, Israel
San Giovanni Rotondo Foggia, 71013, Italy
Bergamo Lombardia, 24127, Italy
Pesaro Pesaro E Urbino, 61100, Italy
Aviano Pordenone, 33081, Italy
Candiolo Torino, 10060, Italy
Brescia , 25123, Italy
Milano , 20141, Italy
Milano , 20153, Italy
Padova , 35128, Italy
Parma , 43126, Italy
Ravenna , 48100, Italy
Rimini , 47900, Italy
Terni , 05100, Italy
Chiba-city Chiba, 260-8, Japan
Fukuoka-shi Fukuoka, 811-1, Japan
Maebashi-city Gunma, 371-8, Japan
Kobe-city Hyogo, 650-0, Japan
Tsu MIE, 514-8, Japan
Utsunomiya City Tochigi, 320-0, Japan
Tachikawa-city Tokyo, 190-0, Japan
Tokyo , 150-8, Japan
Seoul Gyeonggi-do, 135-7, Korea, Republic of
Seoul Gyeonggi-do, 158-7, Korea, Republic of
Busan Gyeongsangnam-do, 48108, Korea, Republic of
Jinju-si Gyeongsangnam-do, 52727, Korea, Republic of
Daegu , 41931, Korea, Republic of
Daegu , 42415, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 03181, Korea, Republic of
Seoul , 03722, Korea, Republic of
Ulsan , 44033, Korea, Republic of
Mexico City Distrito Federal, 01120, Mexico
Chihuahua , 31203, Mexico
Legnica Dolnoslaskie, 59-22, Poland
Toruń Kujawsko-pomorskie, 87-10, Poland
Kraków Malopolskie, 31-82, Poland
Gdańsk Pomorskie, 80-21, Poland
Targu-Mures Mures, 54004, Romania
Targu-Mures Mures, 54013, Romania
Timisoara Timis, 30002, Romania
Bucuresti , 03017, Romania
Sabadell Barcelona, 08208, Spain
Córdoba Cordoba, 14004, Spain
Majadahonda Madrid, 28222, Spain
La Laguna Tenerife Santa CRUZ DE Tenerife, 38320, Spain
Barcelona , 08003, Spain
Caceres , 10003, Spain
Cadiz , 11009, Spain
Madrid , 28046, Spain
Salamanca , 37007, Spain
Kyiv Kiev, 03115, Ukraine
Kyiv Kiev, 04112, Ukraine
Uzhgorod Transcarpathia, 88014, Ukraine
Chernivtsi , 58013, Ukraine
Dnipropetrovsk , 49055, Ukraine
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