Study Complete
Sponsor ID
20130109
Study to assess if ABP798 is safe & effective in treating non Hodgkin lymphoma compared to rituximabJASMINE
Study Details
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.
Protocol Summary
Primary Outcome Measures
Risk difference (RD) of objective response rate (ORR)
Timeframe: Week 28
Risk difference (RD) of overall response rate (ORR)
Timeframe: Week 28
Secondary Outcome Measures
Risk difference of ORR
Timeframe: Week 12
Percent of subjects with complete depletion of CD19 cell count and total Immunoglobin G (IgG) and IgM antibody levels
Timeframe: Baseline to study day 8
Subject incidence of treatment-emergent AEs and serious adverse events
Timeframe: Up to Week 28
Incidence of anti-drug antibodies
Timeframe: Up to Week 28
On study progression-free survival
Timeframe: Up to Week 28
On study overall survival
Timeframe: Up to Week 28
Geometric mean ratio (GMR) of test (ABP 798)-to-reference (rituximab)
Timeframe: Predose and after end of infusion at week 12
Study Documents
Study Synopsis
Available Language(s): English
Plain Language Summary of Results
Available Language(s): Russian (Ukraine), Urdu, Spanish (Mexico), Marathi, Tamil, Malayalam, Hindi, Kannada, Czech, Russian (Israel), Italian, Hungarian, Hebrew, German, Georgian, Bulgarian, English, Arabic (Israel), French, Greek, Bengali, Telugu, Ukrainian, Spanish (Columbia), Korean, Spanish, Romanian, Polish, Japanese, Gujarati
Locations
Location
Research Site
Ostrava - Poruba, SEVEROMORAVSKY KRAJ, Czech Republic, 708 52
Status
Recruiting
Location
Research Site
Praha 5, Praha, Czech Republic, 150 06
Status
Recruiting
Location
Research Site
Salamanca, Salamanca, Spain, 37007
Status
Recruiting
Location
Research Site
Plovdiv, Plovdiv, Bulgaria, 4002
Status
Recruiting
Location
Research Site
Stara Zagora, STARA ZAGORA, Bulgaria, 6000
Status
Recruiting
Location
Research Site
Majadahonda, Madrid, Spain, 28222
Status
Recruiting
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