CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 50 enrolled
Drug / intervention
Bendamustine hydrochloride +1 moredrug
Likely dose
Bendamustine hydrochloride 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/NCT01108341
NCT01108341Phase 2Completed
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An Open-Label Study to Evaluate the Efficacy and Safety of Treatment With Bendamustine in Combination With Ofatumumab in Previously Untreated Patients With Indolent B-Cell Non-Hodgkin's Lymphoma (NHL)

Cephalon·interventional·Posted Apr 22, 2010·Updated Aug 28, 2012

In Brief

A Phase 2 clinical trial evaluating Bendamustine hydrochloride and Ofatumumab for Non-Hodgkin's Lymphoma (NHL). Completed, enrolled 50 participants across 39 sites in 3 countries.

Detailed Summary

The primary objective of the study is to determine the efficacy, as measured by overall response (complete response + partial response) of bendamustine in combination with ofatumumab in previously untreated patients with indolent B-Cell Non-Hodgkin's Lymphoma (NHL).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Hodgkin's Lymphoma (NHL)
CountriesBelgium, Israel, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 22, 2010
Enrollment StartMay 1, 2010
Primary CompletionJul 1, 2011
Study CompletionOct 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 16.2 years ago

Interventions

Bendamustine hydrochloridedrug

Bendamustine will be administered at 90 mg/m\^2 as a 30-minute intravenous (iv) infusion on days 1 and 2 of each cycle.

Ofatumumabdrug

Ofatumumab will be administered at 300 mg as an iv infusion on day 1 and 1000 mg on day 8 of cycle 1 and 1000 mg on day 1 of each subsequent cycle.