CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 45 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/NCT00891839
NCT00891839Phase 2Completed
CompareCT.gov

An Open-Label Study of Bendamustine Hydrochloride in Combination With Rituximab in the Treatment of Patients With Relapsed/Refractory Mantle Cell Lymphoma

Cephalon·interventional·Posted May 1, 2009·Updated Nov 4, 2014

In Brief

A Phase 2 clinical trial evaluating Bendamustine and Rituximab for Mantle Cell Lymphoma. Completed, enrolled 45 participants across 13 sites in 2 countries.

Detailed Summary

The purpose of this study is to determine the efficacy and safety of the combination of bendamustine and rituximab in patients with relapsed/refractory mantle cell lymphoma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMantle Cell Lymphoma
CountriesCanada, United States
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 1, 2009
Enrollment StartJun 1, 2009
Primary CompletionDec 1, 2011
Study CompletionMay 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 17.2 years ago

Interventions

Bendamustinedrug

Bendamustine at 90 mg/m\^2 intravenously (iv) on days 1 and 2 of each 28-day cycle. Dosage calculations for bendamustine are based on the patient's body surface area (BSA) at baseline, using actual weight for calculations. If there is a 10% change in a patient's weight during treatment, the most recent weight is used to recalculate the BSA. The new BSA is used in determining the doses to be administered in any subsequent cycles.

Rituximabdrug

Patients receive 375 mg/m\^2 of rituximab, administered by iv infusion on day 1 of every 28-day cycle of treatment. Dosage calculations for rituximab are based on the patient's BSA at baseline, using actual weight for calculations. If there is a 10% change in a patient's weight during treatment, the most recent weight is used to recalculate the BSA. The new BSA is used in determining the doses to be administered in any subsequent cycles.