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To Compare Efficacy and Safety Between CT-P10 and Rituxan in Patients With Low Tumour Burden Follicular Lymphoma

NCT02260804 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 258

Last updated 2021-04-08

Study results available
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Summary

To demonstrate that CT-P10 is similar to Rituxan in terms of efficacy as determined by overall response rate at 7 months

Conditions

Interventions

BIOLOGICAL

CT-P10

375mg/m2, IV on day1 of 4 cycles in induction period, and 12 cycles in maintenance period.

BIOLOGICAL

Rituxan

375mg/m2, IV on day1 of 4 cycles in induction period, Rituxan for the first 6 cycles and CT-P10 for the last 6 cycles in maintenance period.

Sponsors & Collaborators

Principal Investigators

  • SungHyun Kim · Celltrion

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-09
Primary Completion
2018-01-04
Completion
2019-09-04

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02260804 on ClinicalTrials.gov