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
- Conditions
- CD20 positive B-cell non-Hodgkin lymphomaMedDRA version: 20.0 Level: HLGT Classification code 10025320 Term: Lymphomas non-Hodgkin's B-cell System Organ Class: 10005329 - Blood and lymphatic system disordersTherapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2013-005542-11-BG
- Lead Sponsor
- Amgen Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 250
Males and females 18 years of age and older
Histological confirmed (by lymph node or extranodal region biopsy), Grade 1, 2, 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 involvment 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 > 16 cm 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)
5. Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1.
Blood counts:
• absolute neutrophil count (ANC) = 1.5 x 109 /L (1,500/µL)
• lymphocytes < 1.5 x the ULN
• platelets = 100 x 109 /L (100,000/µL)
• 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 = 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
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 in the 6 months 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 = 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 the 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)
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> 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)<br> <br> CT Scan: screening, v5 (w12), end of study (w28)<br> <br> Bone marrow biopsy: screening, end of study (w28)<br> <br> Serum chemistry & Hematology: screening, v1 (D1), v2 (w2), v3 (w3), v4 (w4), v5 (w12), v6 (w20), end of study (w28)<br> <br> Pharmacodynamic (CD19) and IgG and IgM: v1 (D1), v2 (w2), v3 (w3), v4 (w4), end of study (w28)<br> ;Main Objective: To evaluate the efficacy of ABP 798 compared with rituximab;Secondary Objective: To assess the pharmacokinetics (PK), pharmacodynamics, safety, tolerability, and immunogenicity of ABP 798 compared with rituximab;Primary end point(s): Primary efficacy endpoint: (risk difference [RD] of overall response rate [ORR] by week 28
- Secondary Outcome Measures
Name Time Method