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

NCT02747043 | Completed Phase 3 Results DMC

• 2 other identifiers: 201301092013-005542-11
• Study Type: interventional
• Target: 256
• Locations: 20 countries
• Sites: 98

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.

Conditions

Lymphoma, Non-Hodgkin

Keywords

CD20 Positive B-cell Non-Hodgkin Lymphoma; ABP 798

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Responded (Overall Response Rate - ORR) by Week 28 Based on Independent Central Assessment of Disease

  Overall response within the first treatment cycle was assessed according to International Working Group - Non-Hodgkin Lymphoma criteria (IWG-NHL criteria \[Cheson et al, 1999\]) by a central reader. Response was evaluated using computerized tomography (CT) scans and positron emission tomography (PET) (to assess nodal disease/organ enlargement), and bone marrow biopsy (to assess bone marrow infiltration). ORR was the percentage of participants with a best overall response of complete response (CR), unconfirmed complete response (CRu) or partial response (PR). Participants that do not meet the criteria for response were considered non-responders. CR was defined as no evidence of disease. CRu showed nodes in the original sum of the products (SPD) regressed by \>75% and/or indeterminate bone marrow results. PR was a ≥ 50% decrease in SPD of the six largest dominant nodes; \>=50% decrease in liver and spleen nodes, and no increase in size of other nodes nor any new sites of disease.

  Post treatment up to Week 28

Secondary Outcomes (10)

• Percentage of Participants Who Responded (Overall Response Rate - ORR) at Week 12 Based on Independent Central Assessment of Disease

  Week 12

• Pharmacokinetic Serum Concentrations by Visit

  Weeks 2, 3, 4, 12 and 20

• Percentage of Participants With Complete Depletion of Clusters of Differentiation 19-Positive (CD19+) Cell Count From Baseline to Day 8

  Baseline (Day 1), Study Day 8

• Total Immunoglobulin G (IgG) Results by Visit

  Baseline (Day 1), Day 8 (Week 2), Weeks 3, 4, 28

• Total Immunoglobulin M (IgM) Results by Visit

  Baseline (Day 1), Day 8 (Week 2), Weeks 3, 4, 28

Study Arms (2)

ABP 798

EXPERIMENTAL

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.

Biological: ABP 798

Rituximab

ACTIVE COMPARATOR

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.

Biological: Rituximab

Interventions

ABP 798 BIOLOGICAL

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.

Also known as: biosimilar to rituximab

ABP 798

Rituximab BIOLOGICAL

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.

Also known as: Rituxan

Rituximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Amgen: lead

Study Sites (98)

Research Site

Encinitas, California, 92024-1332, 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 2X3, Canada

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Medellín, Antioquia, 050034, Colombia

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Bogota, Cundinamarca, 110111, Colombia

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Prague, Prague, 150 06, Czechia

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Ostrava - Poruba, Severomoravsky KRAJ, 708 52, Czechia

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Bordeaux, Aquitaine, 33077, France

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Clermont-Ferrand, Auvergne, 63050, France

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Cesson-Sévigné, Brittany Region, 35576, France

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Boulogne-sur-Mer, Hauts-de-France, 62321, France

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La Rochelle, Poitou-charentes, 17000, France

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Poitiers, 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 im Breisgau, Baden-Wurttemberg, 79110, Germany

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Augsburg, Bavaria, 86156, Germany

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Würzburg, Bavaria, 97080, Germany

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Kassel, Hesse, 34125, Germany

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Münster, North Rhine-Westphalia, 48149, Germany

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Leipzig, Saxony, 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, 395010, India

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Vadodara, Gujarat, 390001, India

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Bangalore, Karnataka, 560068, India

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Mangalore, Karnataka, 575001, India

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Nashik, Maharashtra, 422004, India

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Pune, Maharashtra, 411 001, India

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Bikaner, Rajasthan, 334 003, India

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Be’er Ya‘aqov, Rehoboth, 7030000, Israel

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San Giovanni Rotondo, Foggia, 71013, Italy

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Bergamo, Lombardy, 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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Milan, 20141, Italy

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Milan, 20153, Italy

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Padua, 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, Chiba, 260-8717, Japan

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Fukuoka, Fukuoka, 811-1395, Japan

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Maebashi, Gunma, 371-8511, Japan

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Kobe, Hyōgo, 650-0047, Japan

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Tsu, Mie-ken, 514-8507, Japan

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Utsunomiya, Tochigi, 320-0834, Japan

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Tachikawa, Tokyo, 190-0014, Japan

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Tokyo, 150-8935, Japan

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Mexico City, Mexico City, 01120, Mexico

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Chihuahua City, 31203, Mexico

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Torun, Kuyavian-Pomeranian Voivodeship, 87-100, Poland

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Krakow, Lesser Poland Voivodeship, 31-826, Poland

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Legnica, Lower Silesian Voivodeship, 59-220, Poland

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Gdansk, Pomeranian Voivodeship, 80-219, Poland

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Târgu Mureş, Mureș County, 540042, Romania

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Târgu Mureş, Mureș County, 540136, Romania

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Timișoara, Timiș County, 300021, Romania

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Bucharest, 030171, Romania

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Seoul, Gyeonggi-do, 135-710, South Korea

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Seoul, Gyeonggi-do, 158-710, South Korea

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Jinju, Gyeongsangnam-do, 52727, South Korea

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Pusan, Gyeongsangnam-do, 48108, South Korea

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Daegu, 41931, South Korea

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Daegu, 42415, South Korea

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Seoul, 03080, South Korea

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Seoul, 03181, South Korea

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Seoul, 03722, South Korea

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Ulsan, 44033, South Korea

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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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Cadiz, 11009, Spain

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Cáceres, 10003, Spain

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Madrid, 28046, Spain

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Salamanca, 37007, Spain

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Kyiv, Kyiv City, 03115, Ukraine

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Kyiv, Kyiv City, 04112, Ukraine

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Uzhhorod, Zakarpattia Oblast, 88014, Ukraine

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Chernivtsi, 58013, Ukraine

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Dnipropetrovsk, 49055, Ukraine

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Related Publications (1)

• 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.

  PMID: 33044684 DERIVED

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

medinfo@amgen.com

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2016
• First Posted: April 21, 2016
• Study Start: May 25, 2016
• Primary Completion: June 28, 2019
• Study Completion: June 28, 2019
• Last Updated: September 10, 2022
• Results First Posted: August 18, 2020

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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.

Locations

UA (5); IN (7); CA (1); KR (10); ES (9); US (5); GR (3); CZ (2); BU (2); ME (2); IL (1); FR (6); JP (8); AU (3); PL (4); RO (4); DE (7); CO (2); GE (4); IT (13)