Study Complete
Sponsor ID
20130109

Study to assess if ABP798 is safe & effective in treating non Hodgkin lymphoma compared to rituximabJASMINE

Sponsor ID
20130109
Clinicaltrials.gov ID
NCT02747043
EUCTIS ID
N/A
EudraCT ID
2013-005542-11

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.

Additional Study Details

Phase
Phase 3
Product
N/A
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
256
Additional Study Details

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
Status
Contact Us
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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