CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 394 enrolled
Drug / intervention
PF-05280586 +1 morebiological
Likely dose
PF-05280586 375mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02213263
NCT02213263Phase 3Completed
CompareCT.gov

A PHASE 3, RANDOMIZED, DOUBLE-BLIND STUDY OF PF-05280586 VERSUS RITUXIMAB FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH CD20-POSITIVE, LOW TUMOR BURDEN, FOLLICULAR LYMPHOMA

Pfizer·interventional·Posted Aug 11, 2014·Updated Jun 20, 2019

In Brief

A Phase 3 clinical trial evaluating PF-05280586 and MabThera® for Follicular Lymphoma. Completed, enrolled 394 participants across 423 sites in 30 countries.

Detailed Summary

This study will compare the safety and effectiveness of PF-05280586 versus rituximab-EU in patients with CD20-positive, low tumor burden follicular lymphoma. The primary hypothesis to be tested in this study is that the effectiveness of PF-05280586, as measured by the Overall Response Rate, is similar to that of rituximab-EU.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFollicular Lymphoma
CountriesAustria, Belarus, Belgium, Brazil, Croatia, France, Georgia, Germany, Greece, India, Italy, Japan, Lebanon, Mexico, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, South Africa, South Korea, Spain, Switzerland, Thailand, Turkey (Türkiye), Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedAug 11, 2014
Enrollment StartSep 30, 2014
Primary CompletionOct 23, 2017
Study CompletionApr 19, 2018
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 11.9 years ago

Interventions

PF-05280586biological

PF-05280586 (rituximab-Pfizer) concentrate for solution for infusion 375mg/m2 administered via IV infusion on Days 1, 8, 15, and 22

MabThera®biological

MabThera® (rituximab-EU) concentrate for solution for infusion 375mg/m2 administered via IV infusion on Days 1, 8, 15, and 22