A Multicenter, Open Label, Phase II Study of Bendamustine and Rituximab followed by 90-yttrium (Y) Ibritumomab Tiuxetan for Untreated Follicular Lymphoma (Fol-BRITe)

Conditions

Follicular Lymphoma

What is the purpose of this trial?

STUDY OBJECTIVES

Primary Objective:

To determine the complete response (CR) rate and overall response (OR) rate [CR + partial response (PR) rate] to a regimen of bendamustine and rituximab (B-R), followed by radioimmunotherapy (RIT) with 90-yttrium(Y) ibritumomab tiuxetan in subjects with untreated follicular lymphoma.

Secondary Objectives:

To characterize the safety profile of bendamustine and rituximab followed by 90-yttrium(Y) ibritumomab tiuxetan in subjects with untreated follicular lymphoma

To determine the CR and OR rate after B-R

To determine the CR and OR rate after 90-yttrium(Y) ibritumomab tiuxetan specifically the conversions from PR to CR

To determine the progression-free survival (PFS)

To determine time to next treatment (TTNT)

Exploratory Objectives:

To determine the molecular response after B-R as determined by qualitative polymerase chain reaction (PCR) of BCL2 from blood and bone marrow examination (required after B-R)

To determine the molecular response after 90-yttrium(Y) ibritumomab tiuxetan radioimmunotherapy from blood and bone marrow examination (required after RIT)


Participation Guidelines

Age:
18 Years and older
Gender:
Both

Click here for detailed information about who can participate in this trial.


Sponsor:
Cephalon
Dartmouth-Hitchcock Medical Center
Spectrum Pharmaceuticals, Inc
Dates:
October 2012
Last Updated:
Study HIC#:
1207010545

Clinicaltrials.gov ID: Yale2349468