CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 51 enrolled
Drug / intervention
Bendamustine +2 moredrug
Likely dose
Bendamustine 20 mg/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/NCT01096992
NCT01096992Phase 2Completed
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A Phase I/II Clinical Trial of Fludarabine, Bendamustine, and Rituximab (FBR) in Previously Treated Patients With Chronic Lymphocytic Leukemia (CLL)

M.D. Anderson Cancer Center·interventional·Posted Mar 31, 2010·Updated Sep 25, 2019

In Brief

A Phase 2 clinical trial evaluating Bendamustine, Fludarabine, and 1 other intervention for Leukemia. Completed, enrolled 51 participants across 1 site.

Detailed Summary

The goal of Phase 1 of this clinical research study is to find the highest tolerable dose of bendamustine, combined with fludarabine and rituximab, that can be given to patients who have CLL that has been treated before. The goal of Phase 2 of this study is to find out if this drug combination can help to control the disease. The safety of this drug combination will also be studied.

Study Details

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

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 31, 2010
Enrollment StartApr 19, 2010
Primary CompletionMar 31, 2017
TodayJul 2, 2026
Enrollment to primary: 7.0 yearsPosted 16.3 years ago

Interventions

Bendamustinedrug

Phase 1: Starting Dose of 20 mg/m2 IV on Days 1,2,3 (after fludarabine) Phase 2: 30 mg/m2 by vein (fixed) on Days 1,2,3 (after fludarabine)

Fludarabinedrug

Course 1: 20 mg/m2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m2 IV, Days 1,2,3

Rituximabdrug

Course 1: 375 mg/m2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m2 IV, Day 1