Clinical trial NCT02747043: Study to Assess if ABP798 is Safe & Effective in Treating Non Hodgkin Lymphoma Compared to Rituximab
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lymphoma, Non-Hodgkin
Keywords: CD20 Positive B-cell Non-Hodgkin Lymphoma
ABP 798
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2016-04-21
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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)

Primary outcomes:
measure: Percentage of Participants Who Responded (Overall Response Rate - ORR) by Week 28 Based on Independent Central Assessment of Disease
timeFrame: Post treatment up to Week 28
Secondary outcomes:
measure: Percentage of Participants Who Responded (Overall Response Rate - ORR) at Week 12 Based on Independent Central Assessment of Disease
timeFrame: Week 12
measure: Pharmacokinetic Serum Concentrations by Visit
timeFrame: Weeks 2, 3, 4, 12 and 20
measure: Percentage of Participants With Complete Depletion of Clusters of Differentiation 19-Positive (CD19+) Cell Count From Baseline to Day 8
timeFrame: Baseline (Day 1), Study Day 8
measure: Total Immunoglobulin G (IgG) Results by Visit
timeFrame: Baseline (Day 1), Day 8 (Week 2), Weeks 3, 4, 28
measure: Total Immunoglobulin M (IgM) Results by Visit
timeFrame: Baseline (Day 1), Day 8 (Week 2), Weeks 3, 4, 28
measure: Participants With Treatment-Emergent Adverse Events
timeFrame: Day 1 (post treatment) to Week 28
measure: Percentage of Participants With Treatment-emergent Adverse Events of Interest (AEOIs)
timeFrame: Day 1 (post treatment) to Week 28
measure: Number of Participants Who Developed Anti-drug Antibodies
timeFrame: Baseline (Day 1), Weeks 12, 20 and 28
measure: Participants' Progression-Free Survival (PFS) Status Based on the Independent Central Assessment of Disease
timeFrame: Day 1 up to Week 28
measure: Percentage of Participants Who Survived -- Overall Survival (OS)
timeFrame: Day 1 up to Week 28
Other outcomes:
Locations:
city: Encinitas
country: United States
facility: Research Site
state: California
city: Mount Sterling
country: United States
facility: Research Site
state: Kentucky
city: Billings
country: United States
facility: Research Site
state: Montana
city: Zanesville
country: United States
facility: Research Site
state: Ohio
city: Roanoke
country: United States
facility: Research Site
state: Virginia
city: Gosford
country: Australia
facility: Research Site
state: New South Wales
city: Frankston
country: Australia
facility: Research Site
state: Victoria
city: Perth
country: Australia
facility: Research Site
state: Western Australia
city: Plovdiv
country: Bulgaria
facility: Research Site
city: Stara Zagora
country: Bulgaria
facility: Research Site
city: Windsor
country: Canada
facility: Research Site
state: Ontario
city: Medellin
country: Colombia
facility: Research Site
state: Antioquia
city: Bogota
country: Colombia
facility: Research Site
state: Cundinamarca
city: Praha 5
country: Czechia
facility: Research Site
state: Praha
city: Ostrava - Poruba
country: Czechia
facility: Research Site
state: Severomoravsky KRAJ
city: Bordeaux Cedex
country: France
facility: Research Site
state: Aquitaine
city: Clermont Ferrand
country: France
facility: Research Site
state: Auvergne
city: Cesson-Sevigne
country: France
facility: Research Site
state: Bretagne
city: Boulogne sur Mer
country: France
facility: Research Site
state: NORD Pas-de-calais
city: La Rochelle
country: France
facility: Research Site
state: Poitou-charentes
city: Poitiers Cedex
country: France
facility: Research Site
state: Poitou-charentes
city: Batumi
country: Georgia
facility: Research Site
city: Tbilisi
country: Georgia
facility: Research Site
city: Tbilisi
country: Georgia
facility: Research Site
city: Tbilisi
country: Georgia
facility: Research Site
city: Freiburg
country: Germany
facility: Research Site
state: Baden-wuerttemberg
city: Augsburg
country: Germany
facility: Research Site
state: Bayern
city: Würzburg
country: Germany
facility: Research Site
state: Bayern
city: Kassel
country: Germany
facility: Research Site
state: Hessen
city: Münster
country: Germany
facility: Research Site
state: Nordrhein-westfalen
city: Leipzig
country: Germany
facility: Research Site
state: Sachsen
city: Flensburg
country: Germany
facility: Research Site
state: Schleswig-holstein
city: Athens
country: Greece
facility: Research Site
state: Attica
city: Athens
country: Greece
facility: Research Site
state: Attica
city: Patra
country: Greece
facility: Research Site
state: Peloponnese
city: Surat
country: India
facility: Research Site
state: Gujarat
city: Vadodara
country: India
facility: Research Site
state: Gujarat
city: Bangalore
country: India
facility: Research Site
state: Karnataka
city: Mangalore
country: India
facility: Research Site
state: Karnataka
city: Nashik
country: India
facility: Research Site
state: Maharashtra
city: Pune
country: India
facility: Research Site
state: Maharashtra
city: Bikaner
country: India
facility: Research Site
state: Rajasthan
city: Be'er Ya'akov
country: Israel
facility: Research Site
state: Rehoboth
city: San Giovanni Rotondo
country: Italy
facility: Research Site
state: Foggia
city: Bergamo
country: Italy
facility: Research Site
state: Lombardia
city: Pesaro
country: Italy
facility: Research Site
state: Pesaro E Urbino
city: Aviano
country: Italy
facility: Research Site
state: Pordenone
city: Candiolo
country: Italy
facility: Research Site
state: Torino
city: Brescia
country: Italy
facility: Research Site
city: Milano
country: Italy
facility: Research Site
city: Milano
country: Italy
facility: Research Site
city: Padova
country: Italy
facility: Research Site
city: Parma
country: Italy
facility: Research Site
city: Ravenna
country: Italy
facility: Research Site
city: Rimini
country: Italy
facility: Research Site
city: Terni
country: Italy
facility: Research Site
city: Chiba-city
country: Japan
facility: Research Site
state: Chiba
city: Fukuoka-shi
country: Japan
facility: Research Site
state: Fukuoka
city: Maebashi-city
country: Japan
facility: Research Site
state: Gunma
city: Kobe-city
country: Japan
facility: Research Site
state: Hyogo
city: Tsu
country: Japan
facility: Research Site
state: MIE
city: Utsunomiya City
country: Japan
facility: Research Site
state: Tochigi
city: Tachikawa-city
country: Japan
facility: Research Site
state: Tokyo
city: Tokyo
country: Japan
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Research Site
state: Gyeonggi-do
city: Busan
country: Korea, Republic of
facility: Research Site
state: Gyeongsangnam-do
city: Jinju-si
country: Korea, Republic of
facility: Research Site
state: Gyeongsangnam-do
city: Daegu
country: Korea, Republic of
facility: Research Site
city: Daegu
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Ulsan
country: Korea, Republic of
facility: Research Site
city: Mexico City
country: Mexico
facility: Research Site
state: Distrito Federal
city: Chihuahua
country: Mexico
facility: Research Site
city: Legnica
country: Poland
facility: Research Site
state: Dolnoslaskie
city: Toruń
country: Poland
facility: Research Site
state: Kujawsko-pomorskie
city: Kraków
country: Poland
facility: Research Site
state: Malopolskie
city: Gdańsk
country: Poland
facility: Research Site
state: Pomorskie
city: Targu-Mures
country: Romania
facility: Research Site
state: Mures
city: Targu-Mures
country: Romania
facility: Research Site
state: Mures
city: Timisoara
country: Romania
facility: Research Site
state: Timis
city: Bucuresti
country: Romania
facility: Research Site
city: Sabadell
country: Spain
facility: Research Site
state: Barcelona
city: Córdoba
country: Spain
facility: Research Site
state: Cordoba
city: Majadahonda
country: Spain
facility: Research Site
state: Madrid
city: La Laguna Tenerife
country: Spain
facility: Research Site
state: Santa CRUZ DE Tenerife
city: Barcelona
country: Spain
facility: Research Site
city: Caceres
country: Spain
facility: Research Site
city: Cadiz
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Salamanca
country: Spain
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
state: Kiev
city: Kyiv
country: Ukraine
facility: Research Site
state: Kiev
city: Uzhgorod
country: Ukraine
facility: Research Site
state: Transcarpathia
city: Chernivtsi
country: Ukraine
facility: Research Site
city: Dnipropetrovsk
country: Ukraine
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: 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.