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

Completed · Phase 3

Conditions studied: Lymphoma, Non-Hodgkin

In brief

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.

Key facts

Study ID

NCT02747043

Run by

Amgen

People needed

256

Starts

2016-05-25

Expected to finish

2019-06-28

Last updated by the study team

2022-09-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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)

Where it is running

• Research Site — Mount Sterling, Kentucky, United States
• Research Site — Billings, Montana, United States
• Research Site — Zanesville, Ohio, United States
• Research Site — Roanoke, Virginia, United States
• Research Site — Gosford, New South Wales, Australia
• Research Site — Frankston, Victoria, Australia
• Research Site — Perth, Western Australia, Australia
• Research Site — Plovdiv, Bulgaria
• Research Site — Stara Zagora, Bulgaria
• Research Site — Windsor, Ontario, Canada
• Research Site — Medellín, Antioquia, Colombia
• Research Site — Bogota, Cundinamarca, Colombia
• Research Site — Prague, Prague, Czechia
• Research Site — Ostrava - Poruba, Severomoravsky KRAJ, Czechia
• Research Site — Bordeaux, Aquitaine, France
• Research Site — Clermont-Ferrand, Auvergne, France
• Research Site — Cesson-Sévigné, Brittany Region, France
• Research Site — Boulogne-sur-Mer, Hauts-de-France, France
• Research Site — La Rochelle, Poitou-charentes, France
• Research Site — Poitiers, Poitou-charentes, France
• Research Site — Batumi, Georgia
• Research Site — Tbilisi, Georgia
• Research Site — Tbilisi, Georgia
• Research Site — Tbilisi, Georgia
• Research Site — Encinitas, California, United States

Full record on ClinicalTrials.gov

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