CD20 positive B-cell non-Hodgkin lymphoma MedDRA version: 20.0 Level: HLGT Classification code 10025320 Term: Lymphomas non-Hodgkin's B-cell System Organ Class: 10005329 - Blood and lymphatic system disorders
Conditions
Interventions
Product Name: ABP 798
Product Code: ABP 798
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: rituximab
CA
Sponsors
Amgen Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 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 > 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 g/dL (1,500/µL) • lymphocytes =65 years) yes F.1.3.1 Number of subjects for this age range 125
Exclusion criteria
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 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 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) 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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; 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Efficacy Criteria: Risk difference (RD) of ORR at week 12 Pharmacokinetic and Pharmacodynamic Criteria: • Serum concentrations at predose and immediately after the end of infusion at week 12. • 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) ; 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) Antidrug antibodies: v1 (D1), v5 (w12), v6 (w20), end of study (w28) | — |
Countries
Australia, Bulgaria, Canada, Colombia, Czech Republic, France, Georgia, Germany, Greece, India, Israel, Italy, Japan, Korea, Republic of, Poland, Romania, Slovakia, Spain, Ukraine, United States
Contacts
Public ContactIHQ Medical Info-Clinical Trials
Amgen (EUROPE) GmbH
Outcome results
None listed