Study to Assess if ABP798 is Safe & Effective in Treating Non Hodgkin Lymphoma Compared to Rituximab
NCT ID: NCT02747043
Last Updated: 2022-09-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
256 participants
INTERVENTIONAL
2016-05-25
2019-06-28
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ABP 798
ABP 798 was administered at a dose of 375 mg/m\^2 as an intravenous (IV) infusion once weekly for 4 weeks followed by dosing at weeks 12 and 20.
ABP 798
ABP 798 was supplied as a sterile, preservative-free liquid concentrate for IV infusion at a concentration of 10 mg/mL in either 100 mg/10 mL or 500 mg/50 mL single-dose vials. Subjects were to receive premedications before each infusion. Premedications were to be given according to local practice for administration of rituximab therapy.
Rituximab
Rituximab was administered at a dose of 375 mg/m\^2 as an IV infusion once weekly for 4 weeks followed by dosing at weeks 12 and 20.
Rituximab
Rituximab was procured from commercial supplies in the US and was supplied as a sterile, clear, colorless, preservative-free liquid concentrate for IV infusion at a concentration of 10 mg/mL in either 100-mg/10 mL or 500-mg/50 mL single-dose vials. Subjects were to receive premedications before each infusion. Premedications were to be given according to local practice for administration of rituximab therapy.
Interventions
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ABP 798
ABP 798 was supplied as a sterile, preservative-free liquid concentrate for IV infusion at a concentration of 10 mg/mL in either 100 mg/10 mL or 500 mg/50 mL single-dose vials. Subjects were to receive premedications before each infusion. Premedications were to be given according to local practice for administration of rituximab therapy.
Rituximab
Rituximab was procured from commercial supplies in the US and was supplied as a sterile, clear, colorless, preservative-free liquid concentrate for IV infusion at a concentration of 10 mg/mL in either 100-mg/10 mL or 500-mg/50 mL single-dose vials. Subjects were to receive premedications before each infusion. Premedications were to be given according to local practice for administration of rituximab therapy.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Research Site
Encinitas, California, United States
Research Site
Mount Sterling, Kentucky, United States
Research Site
Billings, Montana, United States
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Zanesville, Ohio, United States
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Roanoke, Virginia, United States
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Gosford, New South Wales, Australia
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Frankston, Victoria, Australia
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Perth, Western Australia, Australia
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Plovdiv, , Bulgaria
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Stara Zagora, , Bulgaria
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Windsor, Ontario, Canada
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Medellín, Antioquia, Colombia
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Bogota, Cundinamarca, Colombia
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Prague, Prague, Czechia
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Ostrava - Poruba, Severomoravsky KRAJ, Czechia
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Bordeaux, Aquitaine, France
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Clermont-Ferrand, Auvergne, France
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Cesson-Sévigné, Brittany Region, France
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Boulogne-sur-Mer, Hauts-de-France, France
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La Rochelle, Poitou-charentes, France
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Poitiers, Poitou-charentes, France
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Batumi, , Georgia
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Tbilisi, , Georgia
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Tbilisi, , Georgia
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Tbilisi, , Georgia
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Freiburg im Breisgau, Baden-Wurttemberg, Germany
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Augsburg, Bavaria, Germany
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Würzburg, Bavaria, Germany
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Kassel, Hesse, Germany
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Münster, North Rhine-Westphalia, Germany
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Leipzig, Saxony, Germany
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Flensburg, Schleswig-Holstein, Germany
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Athens, Attica, Greece
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Athens, Attica, Greece
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Patra, Peloponnese, Greece
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Surat, Gujarat, India
Research Site
Vadodara, Gujarat, India
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Bangalore, Karnataka, India
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Mangalore, Karnataka, India
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Nashik, Maharashtra, India
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Pune, Maharashtra, India
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Bikaner, Rajasthan, India
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Be’er Ya‘aqov, Rehoboth, Israel
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San Giovanni Rotondo, Foggia, Italy
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Bergamo, Lombardy, Italy
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Pesaro, Pesaro E Urbino, Italy
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Aviano, Pordenone, Italy
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Candiolo, Torino, Italy
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Brescia, , Italy
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Milan, , Italy
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Milan, , Italy
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Padua, , Italy
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Parma, , Italy
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Ravenna, , Italy
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Rimini, , Italy
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Terni, , Italy
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Chiba, Chiba, Japan
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Fukuoka, Fukuoka, Japan
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Maebashi, Gunma, Japan
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Kobe, Hyōgo, Japan
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Tsu, Mie-ken, Japan
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Utsunomiya, Tochigi, Japan
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Tachikawa, Tokyo, Japan
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Tokyo, , Japan
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Mexico City, Mexico City, Mexico
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Chihuahua City, , Mexico
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Torun, Kuyavian-Pomeranian Voivodeship, Poland
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Krakow, Lesser Poland Voivodeship, Poland
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Legnica, Lower Silesian Voivodeship, Poland
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Gdansk, Pomeranian Voivodeship, Poland
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Târgu Mureş, Mureș County, Romania
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Târgu Mureş, Mureș County, Romania
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Timișoara, Timiș County, Romania
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Bucharest, , Romania
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Seoul, Gyeonggi-do, South Korea
Research Site
Seoul, Gyeonggi-do, South Korea
Research Site
Jinju, Gyeongsangnam-do, South Korea
Research Site
Pusan, Gyeongsangnam-do, South Korea
Research Site
Daegu, , South Korea
Research Site
Daegu, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Ulsan, , South Korea
Research Site
Sabadell, Barcelona, Spain
Research Site
Córdoba, Cordoba, Spain
Research Site
Majadahonda, Madrid, Spain
Research Site
La Laguna Tenerife, Santa CRUZ DE Tenerife, Spain
Research Site
Barcelona, , Spain
Research Site
Cadiz, , Spain
Research Site
Cáceres, , Spain
Research Site
Madrid, , Spain
Research Site
Salamanca, , Spain
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Kyiv, Kyiv City, Ukraine
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Kyiv, Kyiv City, Ukraine
Research Site
Uzhhorod, Zakarpattia Oblast, Ukraine
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Chernivtsi, , Ukraine
Research Site
Dnipropetrovsk, , Ukraine
Countries
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References
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Niederwieser D, Hamm C, Cobb P, Mo M, Forsyth C, Tucci A, Hanes V, Delwail V, Hajek R, Chien D. Efficacy and Safety of ABP 798: Results from the JASMINE Trial in Patients with Follicular Lymphoma in Comparison with Rituximab Reference Product. Target Oncol. 2020 Oct;15(5):599-611. doi: 10.1007/s11523-020-00748-4.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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2013-005542-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
20130109
Identifier Type: -
Identifier Source: org_study_id
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