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Register:	EUCTR
Last refreshed on:	10 December 2019
Main ID:	EUCTR2013-005542-11-ES
Date of registration:	04/07/2014
Prospective Registration:	Yes
Primary sponsor:	Amgen Inc.
Public title:	The trial is designed to determine the efficacy and safety of ABP 798 compared with rituximab in subjects with CD 20 positive B-cell non Hodgkin lymphoma
Scientific 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) - Not Applicable
Date of first enrolment:	17/12/2014
Target sample size:	250
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-005542-11
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2
Phase:	Human pharmacology (Phase I): yes Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment
Australia	Belarus	Bulgaria	Canada	Czech Republic	France	Germany	Greece
Hungary	Italy	Japan	Mexico	New Zealand	Poland	Romania	Russian Federation
Serbia	Spain	Taiwan	Ukraine	United States

Contacts

Name:	IHQ Medical Info-Clinical Trials
Address:	Dammstrasse 23, PO Box 1557 CH-6300 Zug Switzerland
Telephone:
Email:	Medinfointernational@amgen.com
Affiliation:	Amgen (EUROPE) GmbH

Name:	IHQ Medical Info-Clinical Trials
Address:	Dammstrasse 23, PO Box 1557 CH-6300 Zug Switzerland
Telephone:
Email:	Medinfointernational@amgen.com
Affiliation:	Amgen (EUROPE) GmbH

Key inclusion & exclusion criteria

Inclusion criteria:
Males and females > or = 18 and < 80 years of age.

Histological confirmed, Grade 1, 2 follicular B-cell NHL expressing CD20 within 3 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 28 days before randomization
- subjects must have had a baseline bone marrow biopsy within 3 months before randomization.

Low tumor burden based on the Groupe d'Etudes des Lymphomes Folliculaires (GELF) criteria.

Blood counts:
- absolute neutrophil count (ANC) > or = 1.5 x 109 g/dL (1,500/?L)
- lymphocytes < 1.5 x the upper limit of normal (ULN)
- platelets > or = 100 x 109 g/dL (100,000/?L)
- hemoglobin ? 10.0 g/dL

Adequate hepatic function as defined by:
-aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2 × ULN.

Adequate renal function as defined by creatinine < 1.5 x ULN or estimated creatinine clearance > or = 50 mL/min calculated by the Cockcroft-Gault method.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 125
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 125

Exclusion criteria:
Diffuse large cell component and/or Grade 3 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).

Any of the following before randomization:
-clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure [New York Heart Association ? Class III], serious uncontrolled cardiac arrhythmia);
- peripheral vascular disease, cerebrovascular accident, or transient ischemic attack in the previous 6 months.

Medically uncontrolled hypertension or systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg.

Known active or history of active tuberculosis (TB).

Positive for hepatitis B surface antigen, hepatitis B core antibody, or hepatitis C virus antibody at screening.

Known to be human immunodeficiency virus positive.

Recent infection requiring a course of systemic anti-infective agents that was completed < or = 7 days before randomization (with the exception of uncomplicated urinary tract infection).

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).

Live vaccines within 28 days prior to the first dose of IP.

History of neurologic symptoms suggestive of central nervous system demyelinating disease
Woman of childbearing potential who is pregnant or is breastfeeding.

Woman of childbearing potential who does not consent to use highly effective methods of birth control (eg, true abstinence, sterilization, birth control pills, Depo Provera injections, or contraceptive implants) during treatment and for an additional 12 months after the last administration of the protocol specified-treatment.

Man with a partner of childbearing potential who does not consent to use highly effective methods of birth control (eg, true abstinence, vasectomy, or a condom in combination with hormonal birth control or barrier methods used by the woman) during treatment and for an additional 12 months after the last administration of the protocol specified treatment.

Subject has known sensitivity to any of the products to be administered during the study, including mammalian cell derived drug products

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

CD20 positive B-cell non-Hodgkin lymphoma
MedDRA version: 17.0 Level: HLGT Classification code 10025320 Term: Lymphomas non-Hodgkin's B-cell System Organ Class: 10005329 - Blood and lymphatic system disorders

Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Intervention(s)

Product Name: ABP 798
Product Code: ABP 798
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: rituximab
CAS Number: 1446410-99-6
Current Sponsor code: ABP 798
Other descriptive name: ABP 798 - Biosimilar to rituximab
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-

Trade Name: Rituxan
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Rituximab
CAS Number: 174722-31-7
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-

Primary Outcome(s)

Primary end point(s): Primary efficacy endpoint: (risk difference [RD] of objective response rate [ORR] by week 28

Secondary Objective: To assess the pharmacokinetics (PK), pharmacodynamics, safety, tolerability, and immunogenicity of ABP 798 compared with rituximab

Main Objective: To evaluate the efficacy of ABP 798 compared with rituximab

Timepoint(s) of evaluation of this end point: Clinical disease assessment & PK sampling: v1 (D1), v2 (w2), v3 (w3), v4 (w4), v5 (w12), v6 (w20), end of study (w28)

CT Scan: screening, v5 (w12), end of study (w28)

Bone marrow biopsy: screening, end of study (w28)

Serum chemistry & Hematology: screening, v1 (D1), v2 (w2), v3 (w3), v4 (w4), v5 (w12), v6 (w20), end of study (w28)

Pharmacodynamic (CD19) and IgG and IgM: v1 (D1), v2 (w2), v3 (w3), v4 (w4), end of study (w28)

Secondary Outcome(s)

Secondary end point(s): Secondary Efficacy Criteria: Risk difference (RD) of overall response rate (ORR) at week 12.

Pharmacokinetic and Pharmacodynamic Criteria:
- Serum concentrations at predose and immediately after the end of infusion at weeks 4, 12, and 20.
-Percent of subjects with complete depletion of CD19 cell count, from baseline to study day 8, and total IgG and IgM antibody levels

Safety Criteria:
-Treatment-emergent adverse events (AEs) and serious AEs (SAEs)
-Clinically significant changes in laboratory values and vital signs
-Incidence of anti-drug antibodies
-On study progression-free survival (PFS)
-On study overall survival (OS)

Secondary ID(s)

2013-005542-11-DE

20130109

Source(s) of Monetary Support

Amgen Inc.

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date:
Contact:

Results

Results available:
Date Posted:
Date Completed:
URL:

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