CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 22 enrolled
Drug / intervention
Bendamustine +1 moredrug
Likely dose
Bendamustine 90 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/NCT01626352
NCT01626352Phase 2Completed

Phase II Study of Bendamustine and Ofatumumab in Elderly Patients With Newly Diagnosed Diffuse Large B-Cell Lymphoma Who Are Poor Candidates for R-CHOP Chemotherapy

SCRI Development Innovations, LLC·interventional·Posted Jun 22, 2012·Updated Nov 22, 2017

In Brief

A Phase 2 clinical trial evaluating Bendamustine and Ofatumumab for Diffuse Large B-Cell Lymphoma. Completed, enrolled 22 participants across 11 sites.

Detailed Summary

This is a single-arm, Phase II study designed to enroll and treat up to 64 patients. All patients in this study will receive ofatumumab and bendamustine as an IV infusion for 6 cycles (a cycle is defined as 21 days in length). Patients will receive as an IV infusion bendamustine Days 1 and 2 of Cycles 1 through 6 and ofatumumab Days 1 and 8 during Cycle 1 only and on Day 1 of Cycles 2 through 6.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJun 22, 2012
Enrollment StartOct 1, 2012
Primary CompletionSep 1, 2016
Study CompletionApr 1, 2017
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 14.0 years ago

Interventions

Bendamustinedrug

Patients will receive as an IV infusion bendamustine 90 mg/m\^2 Days 1 and 2 of Cycles 1 through 6.

Ofatumumabdrug

Patients will receive as an IV infusion ofatumumab 1000-mg IV Days 1 and 8 during Cycle 1 only, and on Day 1 of Cycles 2 through 6