CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 231 enrolled
Drug / intervention
Obinutuzumab +3 moredrug
Likely dose
Obinutuzumab 1000 mgfrom 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/NCT01691898
NCT01691898Phase 2Completed
CompareCT.gov

A Randomized, Open-Label, Multicenter, Phase II Trial Evaluating the Safety and Activity of Pinatuzumab Vedotin (DCDT2980S) in Combination With Rituximab or Polatuzumab Vedotin (DCDS4501A) in Combination With Rituximab and a Non-Randomized Phase Ib/II Evaluation of Polatuzumab Vedotin in Combination With Obinutuzumab in Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma

Genentech, Inc.·interventional·Posted Sep 25, 2012·Updated Feb 21, 2020

In Brief

A Phase 2 clinical trial evaluating Obinutuzumab, Pinatuzumab Vedotin, and 2 other interventions for Follicular Lymphoma and Diffuse Large B-Cell Lymphoma. Completed, enrolled 231 participants across 41 sites in 6 countries.

Detailed Summary

This multicenter, open-label study will evaluate the safety and efficacy of pinatuzumab vedotin (DCDT2980S) or polatuzumab vedotin (DCDS4501A) in combination with rituximab (RTX), as well as of polatuzumab vedotin in combination with obinutuzumab in participants with relapsed or refractory (r/r) follicular lymphoma (FL) and r/r diffuse large B-cell lymphoma (DLBCL).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFollicular Lymphoma, Diffuse Large B-Cell Lymphoma
CountriesCanada, France, Germany, Italy, Netherlands, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 25, 2012
Enrollment StartSep 27, 2012
Primary CompletionMar 8, 2017
Study CompletionFeb 7, 2019
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 13.8 years ago

Interventions

Obinutuzumabdrug

Obinutuzumab 1000 mg will be administered by IV infusion on Days 1, 8, 15 of first 21-Day cycle and on Day 1 of subsequent 21-day cycles for up to 8 cycles.

Pinatuzumab Vedotindrug

Pinatuzumab Vedotin 1.8 or 2.4 mg/kg administered by IV infusion on Day 1 or 2 of every 21-day cycle.

Polatuzumab Vedotindrug

Polatuzumab Vedotin 1.8 or 2.4 mg/kg administered by IV infusion on Day 1 or 2 of every 21-day cycle.

Rituximabdrug

RTX 375 mg/m\^2 administered by IV infusion on Day 1 of every 21-day cycle.