NCT02809053View on ClinicalTrials.gov

A Randomized, Double-blind, Multi-center, Multi-national Trial to Evaluate the Efficacy, Safety, and Immunogenicity of SAIT101 Versus Rituximab as a First-line Immunotherapy Treatment in Patients With Low Tumor Burden Follicular Lymphoma

PHASE3CompletedINTERVENTIONAL
Enrollment

315

Participants

Timeline

Start Date

January 18, 2017

Primary Completion Date

July 17, 2019

Study Completion Date

January 10, 2020

Conditions
Lymphoma, Follicular
Interventions
BIOLOGICAL

SAIT101

Dose of 375mg/m2 body surface area (BSA) i.v. on Days 1, 8, 15, and 22

BIOLOGICAL

MabThera®

Dose of 375mg/m2 body surface area (BSA) i.v. on Days 1, 8, 15, and 22

Trial Locations (25)

1083

Research site, Budapest

2605

Research Site, Canberra

11009

Research site, Cadiz

15000

Reasearch site, Prague

22081

Research site, Hamburg

28040

Research site, Madrid

33343

Research site, Mersin

33505

Research site, Libourne

34098

Research site, Istanbul

49241

Research site, Busan

55139

Research site, Samsun

71013

Research site, San Giovanni Rotondo

86021

Research site, Poitiers

90603

Research site, Whittier

4810469

Research site, Temuco

500 05

Research site, Hradec Králové

128 08

Research site, Prague

05100

Research site, Terni

03720

Research site, Mexico City

0181

Research site, Pretoria

01757

Research site, Seoul

03080

Research site, Seoul

08907

Research site, L'Hospitalet de Llobregat

06340

Research site, Ankara

NR4 7UY

Research site, Norwich

All Listed Sponsors
lead

Archigen Biotech Limited

INDUSTRY

NCT02809053 - A Randomized, Double-blind, Multi-center, Multi-national Trial to Evaluate the Efficacy, Safety, and Immunogenicity of SAIT101 Versus Rituximab as a First-line Immunotherapy Treatment in Patients With Low Tumor Burden Follicular Lymphoma | Biotech Hunter | Biotech Hunter